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Myeloablative Allo HSCT With Related or Unrelated Donor for Heme Disorders

The primary research element is to determine whether a graft-versus-host disease (GVHD) prophylaxis regimen of post-transplant cyclophosphamide, tacrolimus and MMF will reduce the likelihood of chronic GVHD in patients receiving a standard hematopoietic myeloablative stem cell transplant. The treatment related components of this protocol are established clinical practices and are considered non-investigational. The primary endpoint is cumulative incidence of chronic GVHD requiring systemic immunosuppressive treatment at 1 year post-transplant.

Shernan Holtan
sgholtan@umn.edu
All
up to 60 Years old
Phase 2
This study is NOT accepting healthy volunteers
NCT03314974
STUDY00001087
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-
Inclusion Criteria:

• Age: ≤ 60 years of age
• Performance Status: Karnofsky ≥ 80%, Lansky play score ≥ 70
• Consent: Voluntary written consent (adult or legally authorized representative; or parental/guardian)
• Adequate Organ Function:
• Renal: Creatinine <2x upper limit of normal. Patients above this limit must have creatinine clearance ≥ 40 ml/min/1.73m2 as determined by an age-appropriate method, such as cystatin C GFR.
• Hepatic: Bilirubin, AST, alkaline phosphatase <4 times the upper limit of institutional normal
• Pulmonary: Diffusion capacity of oxygen, corrected for hemoglobin, > 50% of predicted. For pediatric patients not able to undergo PFTs or diffusion testing: O2 sat of >95% on room air
• Cardiac: Absence of decompensated congestive heart failure, or uncontrolled arrhythmia and left ventricular ejection fraction > 45%. For children not able to cooperate with MUGA or echocardiography, such should be clearly stated in the physician's documentation
• HIV Status: HIV infection with undetectable viral load. All HIV+ patients must be evaluated by Infectious Disease (ID) and a HIV management plan establish prior to transplantation Other
Inclusion Criteria:

• Women of child bearing potential and sexually active males with partners of child bearing potential must agree to use adequate birth control for the duration of treatment.
• Donor Availability: Patients considered for transplantation must have a sufficient graft as based on current criteria of the University of Minnesota Blood and Marrow Transplantation Program
• Eligible Diseases and Status: Patients are eligible unless their treatment is to be guided by a higher priority protocol.
• Acute Leukemias: Must be in remission by morphology (≤5% blasts). Also a small percentage of blasts that is equivocal between marrow regeneration vs. early relapse are acceptable provided there are no associated cytogenetic markers consistent with relapse.
• Acute Myeloid Leukemia (AML) and related precursor neoplasms: 2nd or greater complete remission (CR); first complete remission (CR1) in patients > 60 years old; CR1 in ≤ 60 years old that is NOT considered as favorable-risk.
• Favorable risk AML is defined as having one of the following:
• t(8,21) without cKIT mutation
• inv(16) or t(16;16) without cKIT mutation
• Normal karyotype with mutated NPM1 and wild type FLT-ITD
• Normal karyotype with double mutated CEBPA
• Acute prolymphocytic leukemia (APL) in first molecular remission at the end of consolidation
• Very high risk pediatric patients with AML: Patients <21 years, however, are eligible with (M2 marrow) with < 25% blasts in marrow after having failed one or more cycles of chemotherapy.
• Acute lymphoblastic leukemia (ALL)/lymphoma: second or greater CR; CR1 unable to tolerate consolidation chemotherapy due to chemotherapy-related toxicities; CR1 high-risk ALL.
• High risk ALL is defined as having one of the following:
• Evidence of high risk cytogenetics, e.g. t(9;22), t(1;19), t(4;11), other MLL rearrangements, IKZF1
• 30 years of age or older at diagnosis
• White blood cell counts of greater than 30,000/mcL (B-ALL) or greater than 100,000/mcL (T-ALL) at diagnosis
• CNS leukemia involvement during the course of disease
• Slow cytologic response (>10% lymphoblasts in bone marrow on Day 14 of induction therapy)
• Evidence of persistent immonophenotypic or molecular minimal residual disease (MRD) at the end of induction and consolidation therapy
• Very high risk pediatric patients with ALL: patients <21 years are also considered high risk CR1 if they had M2 or M3 marrow at day 42 from the initiation of induction or M3 marrow at the end of induction. They are eligible once they achieve a complete remission.
• Chronic Myelogenous Leukemia excluding refractory blast crisis: To be eligible in first chronic phase (CP1) patient must have failed or be intolerant to one or more tyrosine kinase inhibitors.
• Plasma Cell Leukemia after initial therapy, in patients who have achieved at least a partial remission
• Myeloproliferative Neoplasms/Myelofibrosis, either primary as a result of polycythemia vera or essential thrombocythemia, with disease risk of intermediate or high-risk according to DIPSS criteria. Blasts must be <10% by bone marrow aspirate morphology.
• Myelodysplasia (MDS) IPSS INT-2 or High Risk (i.e. RAEB, RAEBt) or Refractory Anemia with severe pancytopenia, transfusion dependence, or high risk cytogenetics or molecular features. Blasts must be < 10% by a representative bone marrow aspirate morphology.
• Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL), Marginal Zone B-Cell Lymphoma or Follicular Lymphoma are eligible if there was disease progression/relapse within 12 of achieving a partial or complete remission. Patients who had remissions lasting > 12 months, are eligible after at least two prior therapies. Patients with bulky disease (nodal mass greater than 5 cm) should be considered for debulking chemotherapy before transplant.
• Lymphoplasmacytic Lymphoma, Mantle-Cell Lymphoma, Prolymphocytic Leukemia are eligible after initial therapy in CR1+ or PR1+.
• Diffuse large Cell NHL > CR/> PR: Patients in CR/PR with initial short remission (<6 months) are eligible, or those who have failed/or are not eligible for autologous transplant.
• Lymphoblastic Lymphoma, Burkitt's Lymphoma, and other high-grade NHL after initial therapy if stage III/IV in CR1/PR1 or after progression if stage I/II < 1 year.
• Multiple Myeloma beyond PR2: Patients with chromosome 13 abnormalities, first response lasting less than 6 months, or β-2 microglobulin > 3 mg/L, may be considered for this protocol after initial therapy.
• Juvenile myelomonocytic leukemia
• Biphenotypic/Undifferentiated/Prolymphocytic Leukemias in first or subsequent CR.
• MRD positive leukemia (AML, ALL or accelerated/blast phase CML). Selected patients in morphologic CR, but with positive immunophenotypic (flow cytometry) or molecular evidence of MRD may be eligible if recent chemotherapy has not resulted in MRD negative status.
• Natural Killer Cell Malignancies
• Acquired Bone Marrow Failure Syndromes except for Fanconi Anemia or Dyskeratosis Congenita
• Other Leukemia Subtypes: A major effort in the field of hematology is to identify patients who are of high risk for treatment failure so that patients can be appropriately stratified to either more (or less) intensive therapy. This effort is continually ongoing and retrospective studies identify new disease features or characteristics that are associated with treatment outcomes. Therefore, if new features are identified after the writing of this protocol, patients can be enrolled with the approval of two members of the study committee.
Exclusion Criteria:

• Chemotherapy refractory large cell and high grade NHL (i.e., progressive disease after > 2 salvage regimens)
• CML in blast crisis
• Large cell lymphoma, mantle cell lymphoma and Hodgkin disease that is progressing on salvage therapy.
• Evidence of progressive disease by imaging modalities or biopsy
•persistent PET activity, though possibly related to lymphoma, is not an exclusion criterion in the absence of CT changes indicating progression.
• Active central nervous system malignancy
• if ≤ 18 years old, prior myeloablative transplant within the last 6 months. If >18 years old prior myeloablative allotransplant or autologous transplant
• Active HIV infection or known HIV positive serology
• active uncontrolled infection
• Pregnant or breastfeeding. The agents used in this study include Pregnancy Category D: known to cause harm to a fetus. Females of childbearing potential must have a negative pregnancy test prior to starting therapy.
Biological: HSCT with TBI Regimen, Biological: HSCT with Non-TBI Regimen
Acute Leukemia, Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Lymphoma, Chronic Myelogenous Leukemia, Plasma Cell Leukemia, Myeloproliferative Neoplasms, Myelofibrosis, Myelodysplasia, Refractory Anemia, High Risk Anemia, Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Marginal Zone B-Cell Lymphoma, Follicular Lymphoma, Lymphoplasmacytic Lymphoma, Mantle-Cell Lymphoma, Prolymphocytic Leukemia, Diffuse Large Cell Non Hodgkins Lymphoma, Lymphoblastic Lymphoma, Burkitt Lymphoma, High Grade Non-Hodgkin's Lymphoma, Adult, Multiple Myeloma, Juvenile Myelomonocytic Leukemia, Biphenotypic/Undifferentiated/Prolymphocytic Leukemias, MRD Positive Leukemia, Natural Killer Cell Malignancies, Acquired Bone Marrow Failure Syndromes
AML, ALL, MDS, NHL, CLL, CML, SLL
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Masonic Cancer Center at University of Minnesota — Minneapolis, Minnesota Tamy Grainger, RN - (tgraing1@fairview.org)

Ph I Trial of NAM NK Cells and IL-2 for Adult Pts With MM and NHL

This is a phase I single center study which uses a short course of chemotherapy followed by an infusion of natural killer (NK) cells that has been made from cells collected from the blood of a close relative. These cells, natural killer (NK) cells, are a type of white blood cell known to spontaneously attack cancer cells. Recently it was discovered that adding a derivative of vitamin B (nicotinamide or NAM) while the donor blood cells are being grown in the cell laboratory may improve the NK cell cancer killing ability. It also may improve the NK cells ability home into the tumor cells. The cell product used in this study is referred to as NAM-NK. The primary study endpoint is to determine the Maximum Tolerated Dose (MTD) of NAM-NK cells while maintaining safety.

Veronika Bachanova, MD
bach0173@umn.edu
All
18 Years to 70 Years old
Phase 1
This study is also accepting healthy volunteers
NCT03019666
STUDY00000774
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Patient
Inclusion Criteria:

• ≥18 to ≤70 years of age
• Meets one of the following disease criteria:
• Multiple Myeloma (MM) meeting one of the following:
• relapsed/refractory disease after two lines of therapies, including a proteasome inhibitor (bortezomib, carfilzomib or ixazomib) and an immunomodulatory drug (thalidomide, lenalidomide or pomalidomide)
• relapsed disease between 2-18 months of 1st autologous stem cell transplantation,
• relapsed disease at least 4 months after allogeneic stem cell transplantation with no evidence of active graft versus host disease and no availability of donor lymphocyte infusion
• measurable disease defined as serum IgG, A, M M-protein ≥ 0.5g/dL or serum IgD M-protein ≥ 0.5 g/dL, or urine M-protein ≥ 200 mg/24 hours
• at least 4 weeks since plasmapheresis
• at least 3 days between last corticosteroids and study treatment start
• CD20-positive B-cell Non-Hodgkin Lymphoma (NHL)
• CD20 expression confirmed by flow cytometry or immunohistochemistry and meeting one or more of the following:
• evidence of relapsed/refractory disease that has failed conventional therapy and failed/not eligible/refused studies of a higher priority,
• relapsed disease at least 60 days after autologous stem cell transplantation
• relapsed disease at least 4 months after allogeneic stem cell transplantation with no evidence of active graft versus host disease and no availability of donor lymphocyte infusion
• has measurable disease >1.5 cm in diameter
• HLA-haploidentical or mismatched related donor (aged 12 to 70 years) with donor/recipient match based on a minimum of intermediate resolution DNA based Class I typing of the A and B locus (at least 2/4 class I allele) and absence of recipient anti HLA antibodies against selected donor
• Karnofsky Performance Status ≥ 60%
•appendix III
• Adequate organ function within 14 days of study registration (30 days for pulmonary and cardiac assessments) defined as:
• Bone Marrow: Total white blood cell (WBC) count ≥ 3000/μL, absolute neutrophil count (ANC) ≥ 1000/μL, platelet count ≥ 75,000/μL and hemoglobin ≥ 8.0 g/dL
•may be waived if abnormalities are due to disease related bone marrow involvement
• Renal: creatinine ≤ 1.5 mg/dL or creatinine clearance ≥40mL/min using Cockcroft-Gault formula
• Hepatic: ALT or AST ≤ 3 x upper limit of institutional normal (ULN), total bilirubin ≤ 1.5 x ULN
• Pulmonary Function: oxygen saturation ≥ 90% on room air. If symptomatic or prior known impairment, pulmonary function ≥ 50% corrected DLCO and FEV1 is required
• Cardiac Function: LVEF ≥ 40%, no uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities
• Calcium (MM only): Corrected calcium < 11.5 mg/dL within 2 weeks prior to enrollment
• Able to be off prednisone or other immunosuppressive medications for at least 3 days prior to NAM-NK cell infusion (excluding preparative regimen pre-medications)
• Sexually active females of child bearing potential and males with partners of child bearing potential must agree to use effective contraception during therapy and for 4 months after completion of therapy
• Must have recovered from acute effects of prior therapy
•at least 2 weeks should have elapsed since the last dose of chemotherapy
• Voluntary written consent Patient
Exclusion Criteria:

• Active, untreated CNS involvement
• Chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL), or high-grade lymphomas (Burkittt's lymphoma/Lymphoblastic lymphoma)
• Pregnant or breastfeeding
•The agents used in this study include those that fall under Pregnancy Category D
•have known teratogenic potential. For elotuzumab arm: Women of child bearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 14 days of study treatment start (24 hours prior to the start of elotuzumab)
• Marked baseline prolongation of QT/QTc interval (e.g. demonstration of a QTc interval greater than 500 milliseconds)
• Class II or greater New York Heart Association Functional Classification criteria (appendix III) or serious cardiac arrhythmias likely to increase the risk of cardiac complications of cytokine therapy (e.g. ventricular tachycardia, frequent ventricular ectopy, or supraventricular tachyarrhythmia requiring chronic therapy)
• Active autoimmune disease requiring immunosuppressive therapy
• History of severe asthma, presently on chronic medications (a history of mild asthma requiring inhaled steroids only is eligible)
• New or progressive pulmonary infiltrates on screening chest x-ray or chest CT scan unless cleared for study by Pulmonary. Infiltrates attributed to infection must be stable/improving (with associated clinical improvement) after 1 week of appropriate therapy (4 weeks for presumed or documented fungal infections).
• Active uncontrolled bacterial, fungal, or viral infections
•all prior infections must have resolved following optimal therapy
• Known hypersensitivity to any of the study agents used
• For MM patients only:
• Prior radiotherapy within 2 weeks prior to the administration of study drug"
• Surgery within 4 weeks
• Chemo within 3 weeks (6 weeks for melphalan, or monoclonal antibodies)
• Received investigational drugs within the 14 days before 1st dose of study drug
• High titer of donor specific anti-HLA antibodies (MFI >1000) DONOR INCLUSION CRITERIA:
• HLA-haploidentical or mismatched related donor/recipient match based on a minimum of intermediate resolution DNA based Class I typing of the A and B locus (at least 2/4 class I allele) and absence of recipient anti HLA antibodies
• 12 to 70 years of age
•Priority should be given to age (<35 years), followed by HLA matching (haploidentical and if not available then fully mismatched donor).
• At least 40 kilogram body weight
• In general good health as determined by the evaluating medical provider
• Adequate organ function defined as:
• Hematologic: hemoglobin, WBC, platelet within 10% of upper and lower limit of normal range of test (gender based for hemoglobin),
• Hepatic: ALT < 2 x upper limit of normal,
• Renal: serum creatinine < 1.8 mg/dl
• Performance of a donor infectious disease screen panel including CMV Antibody, Hepatitis B Surface Antigen, Hepatitis B Core Antibody, Hepatitis C Antibody, HIV PCR, HIV ½ Antibody, HTLVA ½ Antibody, Rapid Plasma (RPR) Treponema , Trypanosoma Cruzi (T. Cruzi), HCV by NAT, HIV by NAT and WNV (West Nile Virus) by NAT or per current panel - must be negative for HIV and active hepatitis B
• Not pregnant
•females of childbearing potential must have a negative pregnancy test within 7 days of apheresis
• Able and willing to undergo apheresis
• Voluntary written consent (using assent form if donor < 18 years of age)
Biological: Nicotinamide Expanded Haploidentical or Mismatched Related Donor Natural Killer Cells
Multiple Myeloma, Non-Hodgkin Lymphoma, Diffuse Large B Cell Lymphoma, Mantle-Cell Lymphoma, Follicular Lymphoma, Indolent B Cell Lymphoma, Primary Mediastinal Lymphoma, Lymphoplasmacytic Lymphoma
MM, NHL, NK Cell, NK Cells
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Masonic Cancer Center, University of Minnesota — Minneapolis, Minnesota

Reduced Intensity (RIC) Conditioning And Transplantation of HLA-Haplo-HCT

This is a two stage phase II trial of HLA-haploidentical related hematopoietic cells transplant (Haplo-HCT) using a reduced intensity conditioning (cyclophosphamide, fludarabine, melphalan, total body irradiation) with modifications based on factors including age and comorbidities. Bone marrow is the donor graft source. This study is designed to estimate disease-free survival (DFS) at 1 year posttransplant. Since the goal is to estimate the DFS at a long-term time-point (1 year post-transplant), the design is a generalization of the Simon design. Rather than suspension of the trial for evaluation after stage 1, this design uses an optimal interim analysis for futility without suspension of accrual.

Najla El Jurdi
neljurdi@umn.edu
All
up to 75 Years old
Phase 2
This study is NOT accepting healthy volunteers
NCT02988466
1610M96901
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Inclusion Criteria:

• Karnofsky performance status of ≥70% or Lansky play score ≥ 70%
• A related haploidentical bone marrow donor with up to 2 or 3 HLA locus-mismatches
• The donor and recipient must be HLA identical for at least one haplotype (using high resolution DNA based typing) at the following genetic loci: HLA-A, HLA-B, HLA-C, and HLA-DRB1.
• Adequate liver and renal function
• Absence of decompensated congestive heart failure, or uncontrolled arrhythmia and left ventricular ejection fraction ≥ 40%
• Diffusion capacity corrected (DLCOcorr) > 40% predicted, and absence of O2 requirements
• > 6 months after prior autologous transplant (if applicable)
• Agrees to use contraception during study treatment
• Voluntary written consent (adult or parent/guardian with presentation of the minor information sheet, if appropriate)
• Patients who are HIV+ must have undetectable viral load. All HIV+ patients must be evaluated by Infectious Disease (ID) and a HIV management plan establish prior to transplantation
Exclusion Criteria:

• < 70 years with an available 5-6/6 HLA-A, B, DRB1 matched sibling donor
• Pregnancy or breastfeeding
• Current active and uncontrolled serious infection
• Acute leukemia in morphologic relapse/persistent disease defined as > 5% blasts in normocellular bone marrow OR any % blasts if blasts have unique morphologic markers (e.g. Auer rods).
• CML in blast crisis
• Large cell lymphoma, mantle cell lymphoma and Hodgkin disease that is progressive on salvage therapy.
• stable non-bulky disease is acceptable.
• Active central nervous system malignancy Criteria For Donor Selection:
• Donors must be HLA-haploidentical relatives of the patient, defined as having a shared HLA haplotype between donor and patient at HLA-A, -B, -C, and -DRB1.
• Eligible donors (14-70 years old) include biological children, siblings or half siblings, or parents, able and willing to undergo bone marrow harvesting.
• For donors <18 years, the maximum recipient weight (actual body weight) should not exceed 1.25 times the donor weight (actual body weight)1 In addition, bone marrow product volume should be limited to 20 ml/kg donor weight for donors <18 years.
Biological: Haplo HCT <55 years old, Biological: Haplo HCT ≥55 years old, Drug: GVHD Prophylaxis, Biological: Haplo HCT ≥55 and < 65 years old, Biological: Haplo HCT ≥65 and ≤75 years old
Hematologic Malignancies
Acute Leukemias, Acute myeloid leukemia (AML), Acute lymphoblastic leukemia (ALL)/lymphoma, Biphenotypic/Undifferentiated/Prolymphocytic Leukemias, Myelodysplastic syndrome, Chronic myelogenous leukemia, Minimal Residual Disease (MRD) positive leukemia, Leukemia or Myelodysplastic Syndromes (MDS) in aplasia, Myeloproliferative neoplasms/myelofibrosis, Relapsed large-cell lymphoma, mantle-cell lymphoma and Hodgkin lymphoma, Burkitt's lymphoma, Relapsed T-cell lymphoma, Natural Killer cell malignancies, Relapsed chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), marginal zone B-cell lymphoma, follicular lymphoma, Lymphoplasmacytic lymphoma, Relapsed multiple myeloma, Bone marrow failure syndromes
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Masonic Cancer Center at University of Minnesota — Minneapolis, Minnesota Tim Krepski - (tkrepsk1@fairview.org)

Myeloablative Consolidation Therapy and Tandem Autologous Stem Cell Rescue in Patients With High-Risk Neuroblastoma

To evaluate 3 year progression free survival (PFS) rate of high-risk neuroblastoma patients after treatment with a tandem consolidation of Thiotepa/ Cyclophosphamide and PBSC rescue followed by Carboplatin/Etoposide/ Melphalan (CEM) and PBSC rescue, as compared to historical controls of a single CEM consolidation course with PBSC rescue.

Ashish Gupta
gupta461@umn.edu
All
up to 30 Years old
Phase 2
This study is NOT accepting healthy volunteers
NCT02605421
1601M82901
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• Less than 30 years of age at diagnosis of neuroblastoma
• End of Induction disease evaluation demonstrating CR, PR, MR or SD
• Hematopoietic Recovery from last induction course of chemotherapy
• No uncontrolled infection
• Minimum frozen PBSCs of 2 x 10^6 CD34 cells/kg for each transplant are mandatory and a PBSC of 2 x 10^6 CD34 cells/kg for back-up are strongly recommended (thus, PBSC of no less than 6 x 10^6 CD34 cells/kg is encouraged). These must all be collected prior to the initiation of consolidation.
• Adequate organ function defined as:
• Hepatic: AST and ALT < 3 x upper limit of institutional normal; ALT ≤ 3 x ULN for age; total bilirubin ≤ 1.5 x ULN for age, if baseline was normal, > 1.0 1.5 x baseline if baseline was abnormal
• Cardiac: shortening fraction ≥ 27% or ejection fraction ≥ 45%, no clinical congestive heart failure
• Pulmonary: no evidence of dyspnea at rest and norequirement for supplemental oxygen
• Renal: Creatinine clearance or GFR > 60 mL/min/1.73m^2. If a creatinine clearance is performed at end induction and the result is < 100 ml/min/1.73m^2, a GFR must then be performed using a nuclear blood sampling method or iothalamate clearance method. Camera method is NOT allowed as measure of GFR prior to or during Consolidation therapy for patients with GFR or creatinine clearance of < 100 ml/min/1.73m^2
• Recovery from acute toxicities of last cycle of induction chemotherapy
• Appropriate written consent
•adult or parent/guardian if patient is < 18 years of age and minor information sheet if patient is > 8 years of age
Drug: Thiotepa, Drug: Cyclophosphamide, Drug: Melphalan, Drug: Etoposide, Drug: Carboplatin, Biological: Autologous Stem Cell Infusion, Biological: Granulocyte colony stimulating factor
Neuroblastoma
High-risk neuroblastoma, Neuroblastoma, Myeloablative chemotherapy, Myeloablative consolidation chemotherapy, Autologous peripheral blood stem cell rescue, PBSC, Autologous stem cell rescue
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Masonic Cancer Center, University of Minnesota — Minneapolis, Minnesota Lisa Burke, RN - (lburke3@Fairview.org)

UCB Transplant for Hematological Diseases Using a Non Myeloablative Prep

The primary objective is to estimate the probability of grade II-IV acute GVHD at Day 100 after unrelated donor umbilical cord blood transplantation using a non-myeloablative preparative regimen along with Sirolimus/MMF for GVHD prophylaxis in persons with hematologic malignancies.

Claudio Brunstein, MD
bruns072@umn.edu
All
up to 75 Years old
Phase 2
This study is NOT accepting healthy volunteers
NCT02722668
1603M84843
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Inclusion Criteria:

• Age, Performance Status, and Graft Criteria
• <70 years of age with no matched 5/6 or 6/6 sibling donor
•patients ≥ 70 and ≤ 75 years of age may be eligible if they have a Co-Morbidity score ≤ 2 (http://www.qxmd.com/calculate-online/hematology/hct-ci)
• Karnofsky score ≥ 70% (≥ 16 years) or Lansky score ≥ 50 (< 16 years)
• UCB graft selected according to current University of Minnesota umbilical cord blood graft selection algorithm
• Eligible Diseases All diseases listed below are advanced hematologic malignancies not curable by conventional chemotherapy. Responses to conventional treatment range from zero to 30% but are typically short lived.
• Acute Leukemias: Must be in remission by morphology (<5% blasts). Note cytogenetic relapse or persistent disease without morphologic relapse is acceptable. Also a small percentage of blasts that is equivocal between marrow regeneration vs. early relapse are acceptable provided there are no associated cytogenetic markers consistent with relapse.
• Acute Myeloid Leukemia (AML) and related precursor neoplasms: 2nd or greater complete remission (CR); first complete remission (CR1) in patients > 60 years old; CR1 in ≤ 60 years old that is NOT considered as favorable-risk. Favorable risk AML is defined as having one of the following:
• t(8,21) without cKIT mutation
• inv(16) or t(16;16) without cKIT mutation
• Normal karyotype with mutated NPM1 and wild type FLT-ITD
• Normal karyotype with double mutated CEBPA
• Acute prolymphocytic leukemia (APL) in first molecular remission at the end of consolidation
• Acute lymphoblastic leukemia (ALL)/lymphoma: second or greater CR; CR1 unable to tolerate consolidation chemotherapy due to chemotherapy-related toxicities; CR1 high-risk ALL. High risk ALL is defined as having one of the following:
• Evidence of high risk cytogenetics, e.g. t(9;22), t(1;19), t(4;11), other MLL rearrangements, IKZF1
• 30 years of age or older at diagnosis
• White blood cell counts of greater than 30,000/mcL (B-ALL) or greater than 100,000/mcL (T-ALL) at diagnosis
• CNS leukemia involvement during the course of disease
• Slow cytologic response (>10% lymphoblasts in bone marrow on Day 14 of induction therapy)
• Evidence of persistent immonophenotypic or molecular minimal residual disease (MRD) at the end of induction and consolidation therapy
• Biphenotypic/Undifferentiated/Prolymphocytic Leukemias in first or subsequent CR
• Chronic myelogenous leukemia in chronic or accelerated phase, or CML blast crisis in morphological remission (<5% blasts): Chronic phase patients must have failed at least two tyrosine kinase inhibitors, been intolerant to all available TKIs, or have T315I mutation.
• Myelodysplastic syndrome: IPSS INT-2 or High Risk; R-IPSS High or Very High; WHO classification: RAEB-1, RAEB-2; Severe Cytopenias: ANC < 0.8, Anemia or thrombocytopenia requiring transfusion; Poor or very poor risk cytogenetics based on IPSS or R-IPSS definitions; therapy-related MDS. Blasts must be < 5% by bone marrow aspirate morphology. If ≥5% blasts, patient requires chemotherapy for cytoreduction to <5% blasts prior to transplantation.
• MRD positive leukemia (AML, ALL or accelerated/blast phase CML). Selected patients in morphologic CR, but with positive immunophenotypic (flow cytometry) or molecular evidence of MRD may be eligible if recent chemotherapy has not resulted in MRD negative status.
• Leukemia or MDS in aplasia. These patients may be taken to transplant if after induction therapy they remain with aplastic bone marrow and no morphological or flow-cytometry evidence of disease ≥ 28 days post-therapy. These high risk patients will be analyzed separately.
• Burkitt's lymphoma in CR2 or subsequent CR
• Relapsed T-Cell Lymphoma that is chemotherapy sensitive in CR/PR that has failed or ineligible for an autologous transplant.
• Natural killer cell malignancies
• Large-cell lymphoma, Hodgkin lymphoma and multiple myeloma with chemotherapy sensitive disease who are ineligible for an autologous transplant.
• Relapsed Chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), marginal zone B-cell lymphoma, follicular lymphoma which have progressed within 12 months of achieving a partial or complete remission. Patients who had remissions lasting > 12 months, are eligible after at least two prior therapies. Patients with bulky disease should be considered for debulking chemotherapy before transplant. Patients with refractory disease are eligible, unless bulky disease and an estimated tumor doubling time of less than one month.
• Lymphoplasmacytic lymphoma, mantle-cell lymphoma, prolymphocytic leukemia are eligible after initial therapy if chemotherapy sensitive.
• Relapsed Multiple Myeloma that is chemotherapy sensitive and has failed or ineligible for an autologous transplant.
• Plasma Cell Leukemia after initial therapy if achieved at least in partial remission; or relapsed and achieved subsequent remission (CR/PR)
• Acquired Bone marrow failure syndromes, except for Fanconi anemia
• Myeloproliferative Neoplasms/Myelofibrosis
• Other Leukemia Subtypes: A major effort in the field of hematology is to identify patients who are of high risk for treatment failure so that patients can be appropriately stratified to either more (or less) intensive therapy. This effort is continually ongoing and retrospective studies identify new disease features or characteristics that are associated with treatment outcomes. Therefore, if new features are identified after the writing of this protocol, patients can be enrolled with the approval of two members of the study committee.
• Additional Criteria for Bulky Disease (lymphomas)
• If stable disease is best response, the largest residual nodal mass must < 5 cm (approximately)
• If response to previous therapy, the largest residual mass must represent a 50% reduction and be < 7.5 cm (approximately)
• Organ Function Criteria Adequate organ function is defined as:
• Cardiac: Absence of decompensated congestive heart failure, or uncontrolled arrhythmia and left ventricular ejection fraction > 40%. For children that are not able to cooperate with MUGA and echocardiography, such should be clearly stated in the physician's note.
• Pulmonary: DLCO, FEV1, FVC ≥ 40% predicted, and absence of O2 requirements. For children that are not able to cooperate with PFTs, a pulse oximetry with exercise should be attempted. If neither test can be obtained it should be clearly stated in the physician's note.
• Liver: Transaminases ≤ 5 x upper limit of normal (ULN) and total bilirubin ≤ 2.5 mg/dL except for patients with Gilbert's syndrome or hemolysis
• Renal: Creatinine ≤ 2.0 mg/dl (adults) and creatinine clearance ≥ 40 mL/min (pediatrics). Adults with a creatinine > 1.2 mg/dl or a history of renal dysfunction must have estimated creatinine clearance ≥ 40 ml/min/1.73m^2. Adequate performance status is defined as Karnofsky score ≥ 70% (≥ 16 years of age) or Lansky score ≥ 50 (pediatrics)
• Sexually active females of childbearing potential and males with partners of child-bearing potential must agree to use adequate birth control during study treatment.
• Voluntary written consent (adult or parent/guardian with presentation of the minor information sheet, if appropriate)
Exclusion Criteria:

• Pregnant or breast feeding. The agents used in this study include Pregnancy Category D: known to cause harm to a fetus. Females of childbearing potential must have a negative pregnancy test prior to starting therapy.
• Untreated active infection
• Active HIV infection or known HIV positive serology
• Less than 3 months since prior myeloablative transplant
• Evidence of progressive disease by imaging modalities or biopsy
•persistent PET activity, though possibly related to lymphoma, is not an exclusion criterion in the absence of CT changes indicating progression.
• CML in blast crisis
• Large cell lymphoma, mantle cell lymphoma and Hodgkin disease that is progressing on salvage therapy.
• Active central nervous system malignancy
Drug: Fludarabine, Drug: Cyclophosphamide, Drug: MMF, Drug: Sirolimus, Radiation: TBI, Biological: Umbilical cord blood cell infusion, Biological: ATG
Acute Leukemia, Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia/Lymphoma, Burkitt's Lymphoma, Natural Killer Cell Malignancies, Chronic Myelogenous Leukemia, Myelodysplastic Syndrome, Large-cell Lymphoma, Hodgkin Lymphoma, Multiple Myeloma, Relapsed Chronic Lymphocytic Leukemia, Relapsed Small Lymphocytic Lymphoma, Marginal Zone B-cell Lymphoma, Follicular Lymphoma, Lymphoplasmacytic Lymphoma, Mantle-cell Lymphoma, Prolymphocytic Leukemia, Bone Marrow Failure Syndromes, Myeloproliferative Neoplasms/Myelofibrosis, Biphenotypic/Undifferentiated/Prolymphocytic Leukemias, MRD Positive Leukemia, Leukemia or MDS in Aplasia, Relapsed T-Cell Lymphoma, Relapsed Multiple Myeloma, Plasma Cell Leukemia
AML, ALL, CML, CLL, SLL
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Masonic Cancer Center at University of Minnesota — Minneapolis, Minnesota Claudio Brunstein, MD - (bruns072@umn.edu)

Allo HSCT Using RIC for Hematological Diseases

This is a phase II trial using a non-myeloablative cyclophosphamide/ fludarabine/total body irradiation (TBI) preparative regimen followed by a related or unrelated donor stem cell infusion. It is a modification of the treatment plan which has been studied extensively over the last 10+ years which has shown consistent engraftment and low transplant related mortality (TRM).

Mark Juckett
juck0001@umn.edu
All
up to 75 Years old
Phase 2
This study is NOT accepting healthy volunteers
NCT02661035
1603M85362
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Inclusion Criteria:

• Age, Performance Status, and Graft Criteria
• Age 0 to 70 years of age with Karnofsky score ≥ 70% (≥ 16 years) or Lansky score ≥ 50 (< 16 years)
• Patients ≥ 70 and ≤ 75 years of age may be eligible if they have a HCT-CI Co-Morbidity score ≤ 2
• Must be ≥ 3 months after prior myeloablative transplant, if applicable
• 5/6 or 6/6 related donor match or a 7-8/8 HLA-A,B,C,DRB1 allele matched unrelated donor marrow and/or PBSC donor match per current institutional guidelines Related donors will be evaluated and collected per MT2012-14C; Unrelated donors will be identified and collected per usual procedures
• Eligible Diseases
• Acute Myeloid Leukemia (AML): high risk CR1 (as evidenced by preceding MDS, high risk cytogenetics, ≥ 2 cycles to obtain CR, erythroblastic or megakaryocytic leukemia, FLT-3 ITD +; CR2+. All patients must be in CR as defined by hematological recovery, AND <5% blasts by light microscopy within the bone marrow with a cellularity of ≥15%.
• Very high risk pediatric patients with AML: Patients <21 years, however, are eligible with (M2 marrow) with < 25% blasts in marrow after having failed one or more cycles of chemotherapy.
• Acute Lymphocytic Leukemia (ALL): factor that define high risk CR1 include but are not limited to cytogenetics demonstrating t(9;22), t (1:19), t(4;11), other MLL rearrangements, hypodiploidy, or IKZF1 abnormalities), DNA index < 0.81, > 1 cycle to obtain CR or presence minimal residual disease (MRD). Patients in CR2+ are eligible. All patients must be in CR as defined by hematological recovery, AND <5% blasts by light microscopy within the bone marrow with a cellularity of ≥15%.
• Very high risk pediatric patients with ALL: patients <21 years are also considered high risk CR1 if they had M2 or M3 marrow at day 42 from the initiation of induction or M3 marrow at the end of induction. They are eligible once they achieved a complete remission.
• Chronic Myelogenous Leukemia excluding refractory blast crisis: To be eligible in first chronic phase (CP1) patient must have failed or be intolerant to imatinib mesylate.
• Plasma Cell Leukemia after initial therapy, who achieved at least a partial remission
• Myelodysplasia (MDS) requiring transplant as defined as: IPSS INT-2 or High Risk; R-IPSS High or Very High; WHO classification: RAEB-1, RAEB-2; Severe Cytopenias: ANC < 0.8, Anemia or thrombocytopenia requiring transfusion; Poor or very poor risk cytogenetics based on IPSS or R-IPSS definitions; therapy-related MDS. Blasts must be < 5% by bone marrow aspirate morphology.
• Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL), Marginal Zone B-Cell Lymphoma or Follicular Lymphoma are eligible if there was disease progression/relapse within 12 of achieving a partial or complete remission. Patients who had remissions lasting > 12 months, are eligible after at least two prior therapies. Patients with bulky disease (nodal mass greater than 5 cm) should be considered for de-bulking chemotherapy before transplant.
• Lymphoplasmacytic Lymphoma, Mantle-Cell Lymphoma, Prolymphocytic Leukemia, NK cell malignancies are eligible after initial therapy in CR1+ or PR1+.
• Large Cell NHL > CR2/> PR2: Patients in CR2/PR2 with initial short remission (<6 months) are eligible.
• Lymphoblastic Lymphoma, Burkitt's Lymphoma, and other high-grade NHL after initial therapy if stage III/IV in CR1/PR1 or after progression if stage I/II < 1 year.
• Multiple Myeloma beyond PR2: Patients with chromosome 13 abnormalities, first response lasting less than 6 months, or β-2 microglobulin > 3 mg/L, may be considered for this protocol after initial therapy.
• Myeloproliferative Syndromes
• Organ Function Criteria Adequate organ function is defined as:
• Liver: AST and ALT < 5 x upper limit of normal and bilirubin < 3 x upper limit of normal
• Renal: Creatinine ≤ 2.0 mg/dl (adults) and estimated glomerular filtration rate (GFR) ≥ 40 mL/min (pediatrics). Adults with a creatinine > 1.2 mg/dl or a history of renal dysfunction must have estimated glomerular filtration rate (GFR) > 40 mL/min.
• Albumin > 2.5 g/dL
• Cardiac: Absence of decompensated congestive heart failure, or uncontrolled arrhythmia and left ventricular ejection fraction > 35%.
• Pulmonary: DLCOcorr ≥ 40% predicted, and absence of O2 requirements. For children that are not able to cooperate with PFTs, a pulse oximetry with or without exercise should be attempted. If neither test can be obtained it should be clearly stated in the physician's note.
• If recent mold infection (e.g. aspergillus) must have minimum of 30 days of therapy and responsive disease and be cleared by Infectious Disease
• Females of child bearing potential and sexually active males must agree to use adequate birth control during study treatment
• Voluntary written consent (adult or parent/guardian with presentation of the minor information sheet, if appropriate)
Exclusion Criteria:

• Pregnant or breast feeding. The agents used in this study include Pregnancy Category D: known to cause harm to a fetus. Females of childbearing potential must have a blood test or urine study within 14 days prior to registration to rule out pregnancy.
• Untreated active infection
• Active CNS disease
• Active HIV infection or known HIV positive serology
• Congenital bone marrow failure syndrome
• Previous irradiation that precludes the safe administration of an additional dose of 200 cGy of TBI
• CML in refractory blast crisis
• Intermediate or high grade NHL, mantle cell NHL, and Hodgkin disease that is progressive on salvage therapy. Stable disease is acceptable to move forward provided it is non-bulky.
• Multiple myeloma progressive on salvage chemotherapy
Drug: Allopurinol, Drug: Fludarabine, Drug: Cyclophosphamide, Drug: ATG, Radiation: TBI, Drug: Tacrolimus, Drug: MMF, Biological: Peripheral Blood Stem Cells, Biological: Related or Unrelated Bone Marrow Cells
Acute Myelogenous Leukemia, Acute Lymphocytic Leukemia, Chronic Myelogenous Leukemia, Plasma Cell Leukemia, Myelodysplastic Syndromes, Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, B-Cell Lymphoma, Follicular Lymphoma, Lymphoplasmacytic Lymphoma, Mantle-Cell Lymphoma, Prolymphocytic Leukemia, Lymphoblastic Lymphoma, Burkitt's Lymphoma, Non-Hodgkin's Lymphoma, Multiple Myeloma, Myeloproliferative Syndromes, Hematological Diseases
AML, ALL, CML, MDS, CLL, SLL, NHL
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Masonic Cancer Center at University of Minnesota — Minneapolis, Minnesota Tamy Grainger - (tgraing1@fairview.org)

Identifying Body Awareness-related Brain Network Changes During Cognitive Multisensory Rehabilitation for Reduced Neuropathic Pain in People With Spinal Cord Injury

This mechanistic Phase II clinical trial will utilize a design with a standard parallel-arm RCT. Participants will be randomized into two groups. The Immediate Therapy Group will receive 6 weeks of CMR, 1-on-1, in-person, 3x/week, 45 min/sessions immediately, followed by 6 weeks of standard of care (no therapy) at home as a monitoring/observation period. And the Delayed Therapy Group will first complete the monitoring/observation period with 6 weeks of standard of care (no therapy) at home, followed by 6 weeks of CMR. The healthy group will not receive therapy. The baseline data obtained in the healthy control group will be compared with the baseline data and post-CMR data in both SCI groups.

Ann Van de Winckel
avandewi@umn.edu
All
18 Years to 70 Years old
N/A
This study is also accepting healthy volunteers
NCT04706208
STUDY00008476
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Inclusion Criteria:
SCI participants:
• SCI of ≥ 3months
• medically stable with paraplegia (ASIA grade A-C, who can self-transfer with some assistance)
• neuropathic pain (>3 on the numeric pain rating scale) Able-bodied participants:
• sex and age matched
• healthy, able-bodied
Exclusion Criteria:

•MRI contra-indications (stabilizing hardware is typically MRI safe) including seizures, cognitive impairment, or other major medical complications
Behavioral: Cognitive Multisensory Therapy, Other: Usual Care, Behavioral: Clinical Assessment, Behavioral: Magnetic Resonance Imaging (MRI), Other: OPTIONAL: blood draw
Spinal Cord Injuries, Neuropathic Pain
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University of MInnesota (Brain Body Mind Lab, Division of Physical Therapy, Department of Rehab Med, Medical School) — Minneapolis, Minnesota Ann Van de Winckel - (avandewi@umn.edu)

MT2013-31: Allo HCT for Metabolic Disorders and Severe Osteopetrosis

To evaluate the ability to achieve high-level donor hematopoietic engraftment (defined as neutrophil recovery by Day +42 post-transplant and ≥ 80% donor cells on the myeloid fraction of peripheral blood at Day +100 post-transplant) using related and unrelated BM, PBSC, or UCB grafts following a reduced intensity conditioning regimen based on targeted-exposure busulfan, fludarabine +/- serotherapy in patients with inherited metabolic disorders and severe osteopetrosis.

Paul Orchard
orcha001@umn.edu
All
up to 55 Years old
Phase 2
This study is NOT accepting healthy volunteers
NCT02171104
1406M51542
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Inclusion Criteria:

• 0 through 55 years of age
• Adequate graft available
• Adequate organ function
• Eligible Diseases:
• Mucopolysaccharidosis Disorders:
• MPS IH (Hurler syndrome)
• MPS II (Hunter syndrome) if the patient has no or minimal evidence of symptomatic neurologic disease but is expected to have a neurologic phenotype
• MPS VI (Maroteaux-Lamy syndrome)
• MPS VII (Sly syndrome)
• Glycoprotein Metabolic Disorders:
• Alpha mannosidosis
• Fucosidosis
• Aspartylglucosaminuria
• Sphingolipidoses and Recessive Leukodystrophies:
• Globoid cell leukodystrophy
• Metachromatic leukodystrophy
• Niemann-Pick B patients (sphingomyelin deficiency)
• Niemann-Pick C subtype 2
• Peroxisomal Disorders:
• Adrenoleukodystrophy with cerebral involvement
• Zellweger syndrome
• Neonatal Adrenoleukodystrophy
• Infantile Refsum disease
• Acyl-CoA-Oxidase Deficiency
• D-Bifunctional enzyme deficiency
• Multifunctional enzyme deficiency
• Alpha-methylacyl-CoA Racmase Deficiency (AMACRD)
• Mitochondrial Neurogastrointestingal Encephalopathy (MNGIE)
• Severe Osteopetrosis (OP)
• Hereditary Leukoencephalopathy with axonal spheroids (HDLS; CSF1R mutation)
• Other Inherited Metabolic Disorders (IMD): Patients will also be considered who have other life-threatening, rare lysosomal, peroxisomal or other similar inherited disorders characterized by white matter disease or other neurologic manifestations for which there is rationale that transplantation would be of benefit, such as certain patients with Wolman's disease, GM1 gangliosidosis, I-cell disease, Tay-Sachs disease, Sandhoff disease or others.
• Voluntary written consent
Exclusion Criteria:

• Pregnancy
•menstruating females must have a negative serum or urine pregnancy test within 14 days of study treatment start
• Prior myeloablative chemotherapy exposure within 4 months of the start of conditioning on this protocol (patients excluded for this reason may be eligible for other institutional protocols)
• Uncontrolled bacterial, fungal or viral infections including HIV (including active infection with Aspergillus or other mold within 30 days)
Biological: Stem Cell Transplantation, Drug: IMD Preparative Regimen, Drug: Osteopetrosis Only Preparative Regimen, Drug: Osteopetrosis Haploidentical Only Preparative Regimen, Drug: cALD SR-A (Standard-Risk, Regimen A), Drug: cALD SR-B (Standard-Risk, Regimen B), Drug: cALD HR-D (High-Risk, Regimen C), Drug: cALD HR-D (High-Risk, Regimen D)
Mucopolysaccharidosis Disorders, Hurler Syndrome, Hunter Syndrome, Maroteaux Lamy Syndrome, Sly Syndrome, Alpha-Mannosidosis, Fucosidosis, Aspartylglucosaminuria, Glycoprotein Metabolic Disorders, Sphingolipidoses, Recessive Leukodystrophies, Globoid Cell Leukodystrophy, Metachromatic Leukodystrophy, Niemann-Pick B, Niemann-Pick C Subtype 2, Sphingomyelin Deficiency, Peroxisomal Disorders, Adrenoleukodystrophy With Cerebral Involvement, Zellweger Syndrome, Neonatal Adrenoleukodystrophy, Infantile Refsum Disease, Acyl-CoA Oxidase Deficiency, D-Bifunctional Enzyme Deficiency, Multifunctional Enzyme Deficiency, Alpha-methylacyl-CoA Racmase Deficiency, Mitochondrial Neurogastrointestingal Encephalopathy, Severe Osteopetrosis, Hereditary Leukoencephalopathy With Axonal Spheroids (HDLS, CSF1R Mutation), Inherited Metabolic Disorders
allogeneic hematopoietic cell transplantation, bone marrow transplantation, IMD, AMACRD, MNGIE, HDLS, OP, ALD
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Masonic Cancer Center, University of Minnesota — Minneapolis, Minnesota Lisa Burke - (lburke3@Fairview.org)

Second or Greater Allogeneic Hematopoietic Stem Cell Transplant Using Reduced Intensity Conditioning (RIC)

This is a treatment guideline for a second or greater allogeneic hematopoietic stem cell transplant (HSCT) using a reduced intensity conditioning (RIC) regimen. This regimen, consisting of busulfan, fludarabine, and low dose total body irradiation (TBI), is designed to promote engraftment in patients who failed to achieve an acceptable level of donor-derived engraftment following a previous allogeneic HSCT. While it will primarily be applied for the treatment of non-malignant diseases (NMD), on occasion it may be used to treat patients with malignant disorders as well.

Troy Lund
lundx072@umn.edu
All
up to 55 Years old
N/A
This study is NOT accepting healthy volunteers
NCT01666080
1207M17641
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Inclusion Criteria:

• Diagnosis of any disease for which a second or greater hematopoietic stem cell transplant is needed due to insufficient donor chimerism following hematopoietic recovery after previous HSCT. Determination of "insufficiency of donor chimerism" will be made by the treating transplant physician. Occasionally donor derived engraftment may be present, but sustained aplasia or failed recovery of sufficient hematopoiesis requires administration of a second graft. This intervention may be used for both situations.
• Donor Availability: Patients considered for transplantation must have a sufficient graft as based on current criteria of the University of Minnesota Blood and Marrow Transplantation Program
• Transplantation using sufficiently matched related donors (such as matched siblings) or unrelated donors will be considered. Both granulocyte-colony stimulating factor (GCSF) stimulated peripheral blood grafts and bone marrow grafts will be considered, although bone marrow will be the priority.
• Cord blood grafts, both related and unrelated, are also eligible. As this protocol will use a reduced intensity regimen, this protocol will use the current recommendations of the University of Minnesota for choosing cord blood grafts. If a single cord blood unit cell dose is insufficient, double cord transplantation should be considered if sufficiently matched cord blood units are available. The priority of choosing cord blood donors is based on the current institutional recommendations.
• Exclusion of Metabolic Disorder or other Inherited Disorder Carrier Status from related donor and unrelated cord blood grafts as appropriate for primary disease. At the discretion of the treating transplant physician, an allograft from the previous donor may be used, if available.
• Age, Performance Status, Consent
• Age: 0 to 55 years
• Consent: voluntary written consent (adult or parental/guardian)
Exclusion Criteria:

• Previous irradiation that precludes the safe administration of an additional dose of 200 cGy of total body irradiation (TBI). Radiation Oncology will evaluate all patients who have had previous radiation therapy or TBI for approval to receive an additional 200 cGy of TBI
• Pregnant or breastfeeding
• Active, uncontrolled infection
•infection that is stable or improving after 1 week of appropriate therapy (4 weeks for presumed or documented fungal infections) will be permitted
• HIV positive
• While it would be advantageous to begin therapy on this second transplant regimen > 6 months following a prior myeloablative regimen or >2 months after a reduced intensity regimen, it is recognized that there are circumstances where this may not be practical.
Drug: Busulfan, Drug: Fludarabine, Radiation: Total body irradiation, Biological: Stem cell transplant, Drug: Keppra
Hematologic Disorders, Hemoglobinopathies, Immunodeficiencies
second stem cell transplant, donor hematopoietic engraftment, hematopoietic stem cell transplantation, inherited metabolic disorder
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Masonic Cancer Center, University of Minnesota — Minneapolis, Minnesota Weston P. Miller, M.D. - (mill4991@umn.eud)

Allogeneic Hematopoietic Stem Cell Transplant for Patients With Primary Immune Deficiencies

This is a treatment guideline for allogeneic hemapoetic stem cell transplant (HSCT) in patients with primary immune deficiencies. Endpoints include time to engraftment, incidence of graft failure, incidence of chimerism at 100 days, 6 months, and 1 year; incidence of acute GVHD at 100 days and chronic GVHD at 6 months and 1 year; incidence of transplant related mortality at 6 months and incidence of disease free survival and overall survival at 6 months. All endpoints will be abstracted from routine data collected by the BMT Database.

Christen Ebens
ebens012@umn.edu
All
up to 50 Years old
N/A
This study is NOT accepting healthy volunteers
NCT01652092
1207M17321
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Inclusion Criteria:

• Diagnosis of immunodeficiency or histiocytic disorder including the following:
• Severe combined immunodeficiency (SCID
•all variants)
• Second bone marrow transplant (BMT) for SCID (after graft rejection)
• Omenn's Syndrome
• Reticular dysgenesis
• Wiskott-Aldrich syndrome
• Major histocompatibility complex (MHC) Class II deficiency (bare lymphocyte syndrome)
• Hyper IgM Syndrome (CD40 Ligand Deficiency)
• Common variable immunodeficiency (CVID) with severe phenotype
• Chronic Granulomatous Disease (CGD)
• Other severe Combined Immune Deficiencies (CID)
• Hemophagocytic Lymphohistiocytosis (HLH)
• X-linked Lymphoproliferative Disease (XLP)
• Chediak-Higashi Syndrome (CHS)
• Griscelli Syndrome
• Langerhans Cell Histiocytosis (LCH)
• Acceptable stem cell sources include:
• HLA identical or 1 antigen matched sibling donor eligible to donate bone marrow
• HLA identical or up to a 1 antigen mismatched unrelated BM donor
• Sibling donor cord blood with acceptable HLA match and cell dose as per current institutional standards
• Single unrelated umbilical cord blood unit with 0-2 antigen mismatch and minimum cell dose of >5 x 10^7 nucleated cells/kg as per current institutional guidelines
• Double unrelated umbilical cord blood units that are:
• up to 2 antigen mismatched to the patient
• up to 2 antigen mismatched to each other
• minimum cell dose of at least one single unit must be ≥ 3.5 x 10^7 nucleated cells/kg
• combined dose of both units must provide a total cell dose of ≥ 5 x 10^7 nucleated cells/kg
• Age: 0 to 50 years
• Adequate organ function and performance status. Exclusion Criteria
• pregnant or breastfeeding
• active, uncontrolled infection and/or HIV positive
• acute hepatitis or evidence of moderate or severe portal fibrosis or cirrhosis on biopsy
Drug: Alemtuzumab 0.3 mg, Drug: Cyclophosphamide, Drug: Busulfan, Biological: Stem Cell Transplantation, Drug: Fludarabine phosphate 40 mg, Drug: Melphalan, Drug: Alemtuzumab 0.2 mg, Drug: Busulfan, Drug: Fludarabine phosphate 30 mg, Drug: MESNA
SCID, Omenn's Syndrome, Reticular Dysgenesis, Wiskott-Aldrich Syndrome, Bare Lymphocyte Syndrome, Common Variable Immunodeficiency, Chronic Granulomatous Disease, CD40 Ligand Deficiency, Hyper IgM Syndrome, X-linked Lymphoproliferative Disease, Hemophagocytic Lymphohistiocytosis, Griscelli Syndrome, Chediak-Higashi Syndrome, Langerhan's Cell Histiocytosis
immunodeficiency disorder, histiocytic disorder
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Masonic Cancer Center, University of Minnesota — Minneapolis, Minnesota Angela R. Smith, M.D. - (smith719@umn.edu)

High Dose Chemotherapy and Autologous Transplant for Neuroblastoma

This therapy involves the use of consolidation chemotherapy, autologous stem cell rescue, post-transplant radiation therapy and a maintenance phase with Isotretinoin (Accutane, 13-cis-retinoic acid) therapy. If available, patients should also consider post-transplant therapy with cytokines and monoclonal antibody (ch14.18) on a COG or NANT trial. Ideally, patients should begin consolidation chemotherapy no later than 8 weeks after the start of Induction Cycle #6. (It is strongly recommended to begin consolidation within 4-6 weeks after starting Induction Cycle #6).

Ashish Gupta
gupta461@umn.edu
All
up to 30 Years old
N/A
This study is NOT accepting healthy volunteers
NCT01526603
1112M07741
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Inclusion Criteria:

• Less than 30 years of age at diagnosis of neuroblastoma
• No evidence of disease progression: defined as increase in tumor size of >25% or new lesions
• Recovery from last induction course of chemotherapy (absolute neutrophil count > 500 and platelet > 20,000)
• No uncontrolled infection
• Minimum frozen peripheral blood stem cells (PBSCs) of 2 x 10^6 CD34 cells/kg for transplant are mandatory and 2 x 10^6 CD34 cells/kg for back-up are strongly recommended (thus, PBSC of 4 x 106 CD34 cells/kg is encouraged)
• Adequate organ function defined as:
• Hepatic: aspartate aminotransferase (AST) < 3 x upper limit of institutional normal 8 Cardiac: shortening fraction ≥ 27% or ejection fraction ≥ 50%, no clinical congestive heart failure 8 Renal: Creatinine clearance or glomerular filtration rate (GFR) > 60 mL/min/1.73m^2 If a creatinine clearance is performed at end induction and the result is < 100 ml/min/1.73m^2, a GFR must then be performed using a nuclear blood sampling method or iothalamate clearance method. Camera method is NOT allowed as measure of GFR prior to or during Consolidation therapy for patients with GFR or creatinine clearance of < 100 ml/min/1.73m^2 Exclusion Criteria
• Patients with progressive disease should consider participating in phase I studies since consolidation therapy using the regimen outlined in this document have not been determined to be useful.
• Patients who are delayed in consolidation chemotherapy beyond 8 weeks, and don't meet organ function criteria.
Drug: Carboplatin, Biological: Autologous stem cell infusion, Biological: Granulocyte colony stimulating factor, Radiation: Radiation therapy, Drug: Isotretinoin (13-cis-retinoic acid), Drug: Melphalan, Drug: Etoposide
Neuroblastoma
peripheral blood stem cell transplantation, autologous stem cell transplant
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Masonic Cancer Center, University of Minnesota — Minneapolis, Minnesota Lisa Burke - (lburke3@Fairview.org)

Auto Transplant for High Risk or Relapsed Solid or CNS Tumors

Treatment guidelines for high risk or relapsed solid tumors consisting of a busulfan, melphalan, thiotepa conditioning followed by an autologous peripheral blood stem cell transplant and, if appropriate, disease specific radiation therapy at day 60+

Ashish Gupta
gupta461@umn.edu
All
up to 70 Years old
N/A
This study is NOT accepting healthy volunteers
NCT01505569
1107M02641
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Inclusion Criteria:
All patients must have histological verification of malignancy at original diagnosis.
• Eligible Diseases
• Arm A: Solid Tumor
• Ewing's Family Tumors (ES/PNET/DSRCT)
•metastatic at time of diagnosis and/or relapsed after therapy
• Renal Tumors
•relapsed (all histology
•Wilm's tumor) or at diagnosis (clear cell sarcoma and Rhabdoid tumor)
• Hepatoblastoma
•metastatic at time of diagnosis and/or relapsed after therapy
• Rhabdomyosarcoma
•metastatic at time of diagnosis and/or relapsed after therapy
• Soft Tissue Sarcoma
•chemotherapy responsive metastatic disease or chemotherapy responsive relapsed disease
• Primary Malignant Brain Neoplasms <18 years of age
•at diagnosis and/or relapse
• Retinoblastoma
•disseminated at diagnosis and/or relapsed
• CNS Lymphoma
•primary or secondary CNS lymphoma.
• Other High Risk Metastatic or Relapsed Solid Tumors
•to be approved by 2 or more pediatric hematology/oncology and bone marrow transplant (BMT) physicians
• Arm B: Certain CNS tumors
• Medulloblastoma: Children less than 36 months (3 years) of age at time of definitive surgery (for histopathologic diagnosis) who have high risk Medulloblastoma, defined as any one of the following: 1. > 1.5 cm2 residual disease following resection for any Medulloblastoma histology 2. lumbar CSF cytology positive for tumor cells by analysis of fluid collected either before definitive surgery or at least 10 days after definitive surgery 3. MRI evidence of (a) gross nodular seeding in the intracranial subarachnoid space or ventricular system distant from primary tumor site, M2; or (b) gross nodular seeding in the spinal subarachnoid space +/- evidence of intracranial seeding, M3; or (c) extraneural metastases, M4,
• Anaplastic Histologic Variant Medulloblastoma: less than 70 years of age, any metastatic stage, with total or sub-total resection.
• Infant Medulloblastoma: Children less than 8 months of age at the time of definitive surgery (for histopathologic diagnosis), any histology, any metastatic state, with total or sub-total resection.
• Supra-tentorial Primative Neuro-Ectodermal Tumor (PNET): Children less than 36 months (3 years) of age at time of definitive surgery (for histopathologic diagnosis) with or without metastatic disease
• Atypical Teratoid/Rhabdoid Tumor (AT/RT): less than 70 years of age with CNS AT/RT (with or without metastatic disease).
• Other High Risk CNS Tumors
•to be approved by 2 or more physicians (at least one oncologist and one BMT physician).
• Arm C: Germ Cell Tumors
• Confirmation of germ cell tumor (GCT) histology (both seminoma and nonseminoma). Tumor may have originated in any primary site. NOTE: In rare circumstances, patients will be allowed to enroll even if a pathologic diagnosis may not have been established. This would require a clinical situation consistent with the diagnosis of GCT (testicular, peritoneal, retroperitoneal or mediastinal mass, elevated tumor marker levels {HCG ≥ 500; AFP ≥ 500} and typical pattern of metastases). 1. One or more unfavorable prognostic features for achieving a CR with conventional-dose chemotherapy. Unfavorable prognostic features include: 2. extragonadal primary site 3. PD following an incomplete response (IR) to first-line therapy, 4. PD after a conventional-dose salvage (cisplatin + ifosfamide -based) regimen
• Arm D: Certain CNS Tumor patients who can only undergo one transplant
• Medulloblastoma: Children less than 36 months (3 years) of age at time of definitive surgery (for histopathologic diagnosis) who have high risk Medulloblastoma, defined as any one of the following:
• > 1.5 cm2 residual disease following resection for any Medulloblastoma histology
• lumbar CSF cytology positive for tumor cells by analysis of fluid collected either before definitive surgery or at least 10 days after definitive surgery
• MRI evidence of (a) gross nodular seeding in the intracranial subarachnoid space or ventricular system distant from primary tumor site, M2; or (b) gross nodular seeding in the spinal subarachnoid space +/- evidence of intracranial seeding, M3; or (c) extraneural metastases, M4,
• Anaplastic Histologic Variant Medulloblastoma: less than 70 years of age, any metastatic stage, with total or sub-total resection.
• Infant Medulloblastoma: Children less than 8 months of age at the time of definitive surgery (for histopathologic diagnosis), any histology, any metastatic state, with total or sub-total resection.
• Supra-tentorial Primative Neuro-Ectodermal Tumor (PNET): Children less than 36 months (3 years) of age at time of definitive surgery (for histopathologic diagnosis) with or without metastatic disease
• Atypical Teratoid/Rhabdoid Tumor (AT/RT): less than 70 years of age with CNS AT/RT (with or without metastatic disease).
• Other High Risk CNS Tumors including choroid plexus carcinoma in children- to be approved by 2 or more physicians (at least one oncologist and one BMT physician).
• Arm E: Neuroblastoma ** Neuroblastoma (ICD-O morphology 9500/3) or ganglioneuroblastoma (nodular or intermixed) verified by histology or demonstration of clumps of tumor cells in bone marrow with elevated urinary catecholamine metabolites.
• Disease Status at Enrollment
• Arm A, Arm B and Arm D must have fit one of the following:
• no evidence of disease or
• stable, non-progressive disease (defined as non-progressive abnormalities on physical exam or CT and/or MRI) within 4 weeks of study entry
• Arm C: Evidence of progressive or recurrent GCT (measurable or non-measurable) following one or more cisplatin-based chemotherapy, defined as meeting at least one of the following criteria:
• Tumor biopsy of new or growing or unresectable lesions demonstrating viable non-teratomatous GCT. Patients with incomplete gross resection where viable GCT is found are considered eligible.
• Consecutive elevated serum tumor markers (HCG or AFP) that are increasing. Increase of an elevated LDH alone does not constitute progressive disease.
• Development of new or enlarging lesions in the setting of persistently elevated HCG or AFP, even if the HCG and AFP are not continuing to increase.
• Arm E: Patients with the following disease stages at diagnosis are eligible, if they meet the other specified criteria.
• Patients with newly diagnosed neuroblastoma with INSS Stage 4 are eligible with the following:
• MYCN amplification (> 4-fold increase in MYCN signals as compared to reference signals), regardless of age or additional biologic features or
• Age > 18 months (> 547 days) regardless of biologic features or
• Age 12-18 months (365-547 days) with any of the following 3 unfavorable biologic features (MYCN amplification, unfavorable pathology and/or DNA index = 1) or any biologic feature that is indeterminate/unsatisfactory/unknown.
• Patients with newly diagnosed neuroblastoma with INSS Stage 3 are eligible with the following:
• MYCN amplification (> 4-fold increase in MYCN signals as compared to reference signals), regardless of age or additional biologic features or
• Age > 18 months (> 547 days) with unfavorable pathology, regardless of MYCN status.
• Patients with newly diagnosed neuroblastoma with INSS Stage 2A/2B with MYCN amplification (> 4-fold increase in MYCN signals as compared to reference signals), regardless of age or additional biologic features.
• Patients with newly diagnosed neuroblastoma with INSS Stage 4S with MYCN amplification (> 4-fold increase in MYCN expression signals as compared to reference signals), regardless of additional biologic features.
• Patients ≥ 365 days initially diagnosed with neuroblastoma INSS Stage 1, 2, 4S who progressed to aStage 4 without interval chemotherapy.
• Age and Performance Status
• Age and Performance Status, Arm A
• Age: 0
•70 years
• Performance status: Karnofsky Performance Status ≥ 50% for patients > 16 years of age or Lansky Play Score ≥ 50 for patients ≤ 16 years of age (Note: Neurologic deficits in patients with CNS tumors must be stable for a minimum of 1 week prior to study entry)
• Age and Performance Status, Arm B
• Age: see Eligible diseases, section 3.1, for age criteria
• Performance status: Karnofsky Performance Status ≥ 50% for patients > 16 years of age or Lansky Play Score ≥ 50 for patients ≤ 16 years of age (Note: Neurologic deficits in patients with CNS tumors must be stable for a minimum of 1 week prior to study entry)
• Age and Performance Status, Arm C
• Age: 0-70 years of age
• Performance status: Karnofsky Performance Status ≥ 70% for patients > 16 years of age or Lansky Play Score ≥ 70 for patients ≤ 16 years of age
• Age and Performance Status, Arm D
• Age: see Eligible diseases, section 3.1, for age criteria
• Performance status: Karnofsky Performance Status ≥ 50% for patients > 16 years of age or Lansky Play Score ≥ 50 for patients ≤ 16 years of age (Neurologic deficits in patients with CNS tumors must be stable for a minimum of 1 week prior to study entry)
• Age and Performance Status, Arm E
• Age: Patients must be ≤ 30 years of age at the time of initial diagnosis.
• Performance status: Karnofsky Performance Status ≥ 50% for patients > 16 years of age or Lansky Play Score ≥ 50 for patients ≤ 16 years of age
• Organ Function
• Organ Function, Arm A
• Hematologic: hemoglobin of >9 gm/dl and platelet count > 20,000/μl. Patients may receive transfusions as necessary.
• Renal: GFR ≥ 50 ml/min/1.73m2 or serum creatinine ≤ 2.5 x ULN for age
• Hepatic: AST or ALT ≤ 5 x ULN and bilirubin ≤ 5 x ULN
• Cardiac: ejection fraction ≥ 45% or no clinical evidence of heart failure
• Pulmonary: oxygen saturation > 92% at rest (on room air)
• Organ Function, Arm B (to begin first consolidation cycle)
• Timing: patients must be fully recovered from radiation, induction chemotherapy or surgery prior to receiving consolidation, with minimum elapsed time of 2 weeks.
• Hematologic: ANC > 750/μl, hemoglobin of >8 gm/dl (may receive PRBC transfusions) and platelet count > 75,000/μl (transfusion independent).
• Renal: GFR ≥ 50 ml/min/1.73m2
• Hepatic: AST or ALT ≤ 2.5 x ULN and bilirubin ≤ 1.5 x ULN
• Cardiac: ejection fraction ≥ 45% or no clinical evidence of heart failure
• Pulmonary: oxygen saturation > 94% at rest (on room air)
• Central Nervous System: patients with seizure history are allowed if on anti-convulsants and well controlled; patients must not be in status epilepticus, coma or require assisted ventilation
• Organ Function, Arm C (to begin TI chemotherapy)
• Hematologic: ANC ≥ 750/mm3, platelets ≥ 75,000/mm3
• Renal: GFR ≥ 50 ml/min/1.73m2 or serum creatinine ≤ 2.5 x ULN for age
• Hepatic: AST or ALT ≤ 2.5 x upper limits of normal (ULN), if hepatic involvement < 5 x ULN; bilirubin ≤ 2.0 x upper limits of normal (ULN)
• Arms A and C: Patients with a history of CNS tumor involvement are eligible if they have completed treatment for CNS disease (radiotherapy or surgery or chemotherapy), have recovered from or stabilization of the side effects associated with the therapy and have no evidence of progressive CNS disease at the time of enrollment
• Organ Function, Arm D
• Timing: patients must be fully recovered from radiation, induction chemotherapy or surgery prior to receiving consolidation, with minimum elapsed time of 2 weeks.
• Hematologic: ANC > 750/μl, hemoglobin of >8 gm/dl (may receive PRBC transfusions) and platelet count > 75,000/μl (transfusion independent).
• Renal: GFR ≥ 50 ml/min/1.73m2
• Hepatic: AST or ALT ≤ 2.5 x ULN and bilirubin ≤ 1.5 x ULN
• Cardiac: ejection fraction ≥ 45% or no clinical evidence of heart failure
• Pulmonary: oxygen saturation > 92% at rest (on room air)
• Central Nervous System: patients with seizure history are allowed if on anti-convulsants and well controlled; patients must not be in status epilepticus, coma or require assisted ventilation
• Organ Function, Arm E
• No evidence of disease progression: defined as increase in tumor size of >25% or new lesions.
• Timing: Recovery from last induction course of chemotherapy.
• Minimum frozen PBSC of 4 x 106 CD34 cells/kg as 2 aliquots; i.e. 2 x 106 CD34 cells/kg for each transplant are mandatory. A third aliquot of 2 x 106 CD34 cells/kg is strongly recommended for back-up.
• Hepatic: AST < 3 x upper normal
• Cardiac: Shortening fraction ≥ 27%, or ejection fraction ≥ 50%, no clinical congestive heart failure.
• Renal: Creatinine clearance or GFR > 60 ml/min/1.73m2 (If a creatinine clearance is performed at end of induction and the result is < 100 ml/min/1.73m2, a GFR must be performed using a nuclear blood sampling method or iothalamate clearance method. Camera method is NOT allowed as measure of GFR prior to or during Consolidation therapy for patients with GFR or creatinine clearance of < 100 ml/min/1.73m2.)
Exclusion Criteria:

• Arm A, B, C, and D:
• Pregnant or breastfeeding
• Active, uncontrolled infection and/or human immunodeficiency virus (HIV) positive constitute progressive disease.
• Concomitant enrollment on clinical study (such as COG study) that does not allow co-enrollment on this standard of care protocol (Arm B only)
• Arm E: Pregnant or breastfeeding
• Active, uncontrolled infection and/or HIV positive
• Known contraindication to PBSC collection. Examples of contraindications might be a weight or size less than that determined to be feasible at the collecting institution, or a physical condition that would limit the ability of the child to undergo apheresis catheter placement (if necessary) and/or the apheresis procedure.
• Patients that are 12-18 months of age with INSS Stage 4 and all 3 favorable biologic features (ie, non- amplified MYCN, favorable pathology, and DNA index > 1).
Drug: Ifosfamide, Drug: Etoposide, Drug: Mesna, Biological: G-CSF, Drug: Busulfan, Drug: Melphalan, Drug: Thiotepa, Biological: Autologous stem cell infusion, Radiation: Radiation, Drug: Carboplatin, Drug: Paclitaxel, Procedure: Leukapheresis, Drug: Anti-seizure prophylaxis, Drug: Ursodiol
Ewing's Family Tumors, Renal Tumors, Hepatoblastoma, Rhabdomyosarcoma, Soft Tissue Sarcoma, Primary Malignant Brain Neoplasms, Retinoblastoma, Medulloblastoma, Supra-tentorial Primative Neuro-Ectodermal Tumor (PNET), Atypical Teratoid/Rhabdoid Tumor (AT/RT), CNS Tumors, Germ Cell Tumors
autologous transplantation, high risk solid tumor, relapsed solid tumor
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Masonic Cancer Center, University of Minnesota — Minneapolis, Minnesota Lisa Burke - (lburke3@Fairview.org)

Hematopoietic Stem Cell Transplantation in the Treatment of Infant Leukemia

To determine the incidence of engraftment (defined as achieving donor derived neutrophil count >500/uL by day 42) in young children with leukemia or myelodysplastic syndrome undergoing a partially matched single unit umbilical cord blood transplant (UCBT) after a myeloablative preparative regimen consisting of busulfan, melphalan and fludarabine.

Christen Ebens
ebens012@umn.edu
All
up to 3 Years old
Phase 2
This study is NOT accepting healthy volunteers
NCT00357565
0511M77206
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Inclusion Criteria:

• Matched sibling donor (HLA 8/8), if available, or a unrelated partially HLA matched single unit based on the following priority:
• 1st priority: 4/6 matched unit, cell dose >5 x 10-7 nucleated cells/kg
• 2nd priority: 5/6 matched unit, cell dose > 4 x 10-7 nucleated cells/kg
• 3rd priority: 6/6 matched unit, cell dose > 3 x 10-7 nucleated cells/kg
• Patients aged ≤ 3 years at diagnosis (not age of transplant) with hematological malignancy as detailed below:
• Acute myeloid leukemia: high risk CR1 as evidenced by:
• High risk cytogenetics t(4;11) or other MLL rearrangements; chromosome 5, 7, or 19 abnormalities; complex karyotype (>5 distinct changes); ≥ 2 cycles to obtain complete response (CR); CR2 or higher; Preceding myelodysplastic syndrome (MDS); All patients must be in CR or early relapse (i.e., <15% blasts in BM).
• Acute lymphocytic leukemia: high risk CR1 as evidenced by: High-risk cytogenetic: t(4;11) or other MLL rearrangements; hypodiploid; t(9;22); >1 cycle to obtain CR; CR2 or higher; All patients must be in CR as defined by hematological recovery, AND <5% blasts by light microscopy within the bone marrow with a cellularity of ≥15%.
• Myelodysplasia (MDS) IPSS Int-2 or High risk (i.e. RAEB, RAEBt) or refractory anemia with severe pancytopenia or high risk cytogenetics. Blasts must be < 10% by a representative bone marrow aspirate morphology.
• Persistent or rising minimal residual disease (MRD) after standard chemotherapy regimens: Patients with evidence of minimal residual disease at the completion of therapy or evidence of rising MRD while on therapy. MRD will be defined by either flow cytometry (>0.1% residual cells in the blast gate with immune phenotype of original leukemic clone), by molecular techniques (PCR or FISH) or conventional cytogenetics (g-banding).
• New Leukemia Subtypes: A major effort in the field of pediatric hematology is to identify patients who are of high risk for treatment failure so that patients can be appropriately stratified to either more (or less) intensive therapy. This effort is continually ongoing and retrospective studies identify new disease features or characteristics that are associated with treatment outcomes. Therefore, if new high risk features are identified after the writing of this protocol, patients can be enrolled with the approval of two members of the study committee.
• Recipients must have a Lansky score ≥ 50% and have acceptable organ function defined as:
• Renal: glomerial filtration rate > 60ml/min/1.73m^2
• Hepatic: bilirubin, AST/ALT, ALP < 5 x upper limit of normal,
• Pulmonary function: oxygen saturation >92%
• Cardiac: left ventricular ejection fraction > 45%.
• Voluntary written informed consent before performance of any study-related procedure not part of normal medical care.
Exclusion Criteria:

• Active infection at time of transplantation (including active infection with Aspergillus or other mold within 30 days).
• History of HIV infection or known positive serology
• Myeloablative transplant within the last 6 months.
• Evidence of active extramedullary disease (including central nervous system leukemia).
Biological: filgrastim, Drug: busulfan, Drug: cyclosporine, Drug: fludarabine phosphate, Drug: melphalan, Drug: mycophenolate mofetil, Procedure: umbilical cord blood transplantation
Leukemia, Myelodysplastic Syndromes, Childhood Acute Myeloid Leukemia in Remission, Recurrent Childhood Acute Myeloid Leukemia, Secondary Acute Myeloid Leukemia, Childhood Acute Lymphoblastic Leukemia in Remission, Previously Treated Myelodysplastic Syndrome, Secondary Myelodysplastic Syndrome, Refractory Anemia With Excess Blasts in Transformation, Refractory Anemia With Excess Blasts, Refractory Anemia, De Novo Myelodysplastic Syndrome, Childhood Myelodysplastic Syndrome
MDS, AML
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Masonic Cancer Center, University of Minnesota — Minneapolis, Minnesota Christen Ebens, MD - (ebens012@umn.edu)

Stem Cell Transplant for Juvenile Myelomonocytic Leukemia (JMML)

To determine the probability of long-term disease-free survival in patients with JMML treated with busulfan (BU), cyclophosphamide (CY) and melphalan (L-PAM) followed by hematopoietic cell transplantation.

Margaret MacMillan, MD
macmi002@umn.edu
All
up to 18 Years old
Phase 1/Phase 2
This study is NOT accepting healthy volunteers
NCT00167219
9911M24961
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Inclusion Criteria:

• Patients must have a diagnosis of JMML and fulfill these minimal criteria (International diagnostic criteria for JMML):
• Leukocytosis (> 13,000) with absolute monocytosis (> 1,000)
• The presence of immature myeloid cells in the peripheral blood
• Less than 30% marrow blasts
• Absence of t(9:22) or BCR-ABL transcript
• Adequate major organ function including:
• Cardiac: ejection fraction > 45%
• Hepatic: no clinical evidence of hepatic failure (e.g. coagulopathy, ascites)
• Karnofsky performance status > 70% or Lansky score > 50%
• Creatinine must be < 2 x normal for age
• Written informed consent.
Exclusion Criteria:

• Active uncontrolled infection within one week of HCT.
Biological: Stem Cell Transplant, Drug: Preparative Regimen
Juvenile Myelomonocytic Leukemia
Stem cell transplant, long term survival, retinoic acid
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Masonic Cancer Center, University of Minnesota — Minneapolis, Minnesota Lisa Burke - (lburke3@Fairview.org)

FT596 With Rituximab as Relapse Prevention After Autologous HSCT for NHL

Veronika Bachanova, MD
bach0173@umn.edu
All
18 Years and over
Phase 1
This study is NOT accepting healthy volunteers
NCT04555811
STUDY00010214
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Inclusion Criteria:

• Diagnosis of diffuse large B cell lymphoma or aggressive (high-grade) B-cell lymphoma for which an autologous stem cell transplant is planned or recently completed
• High risk for relapse defined as at least one of the below:
• Primary induction failure (no complete or partial remission at any point after diagnosis
• Initial remission duration < 12 months
• Lack of complete metabolic (PET scan) response after 2-3 cycles of salvage chemotherapy
• Evidence of c-myc and bcl-2 and/or bcl-6 re-arrangement (double hit or triple hit lymphoma)
• Age-adjusted IPI 2-3 at relapse
• Age 18 years or older at the time of signing consent.
• Agrees to use adequate contraception (or evidence of sterility) for at least 12 months after the last dose of rituximab.
• Agrees and signs the separate consent for up to 15 years of follow-up (Long-term Follow-up study CPRC#2020LS052)
• Provides voluntary written consent prior to the performance of any research related activities.
Exclusion Criteria:

• Receipt of any investigational therapy within 28 days prior to the first dose of FT596 or planned use of an investigational therapy during the first 100 days after transplant
• Planned post-transplant irradiation prior to Day +100
• Seropositive for HIV, active Hepatitis B or C infection with detectable viral load by PCR
• Body weight <50kg
• Known allergy to the following FT596 components: albumin (human) or DMSO
• Unable to receive rituximab Post-HSCT Reconfirmation of eligibility
• No life-threatening medical issues (i.e. ongoing Grade 4 adverse events) where, in the opinion of the treating investigator, use of FT596 is not in the patient's best interest.
• No active uncontrolled infection.
• Adequate organ function post-transplant including:
• alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤5 x ULN (Grade 2 CTCAE v5)
• total bilirubin ≤1.5 x ULN (Grade 1 CTCAE v5)
• serum creatinine ≤1.5 x ULN (Grade 1 CTCAE v5)
• oxygen saturation ≥93% on room air
• For Day 30 dosing only
•CBC requirement consistent with engraftment (ANC>500, platelet>20,000 without transfusion support within previous 7 days). There are no CBC parameters for Day 7 dosing.
• No requirement for systemic immunosuppressive therapy (> 5mg prednisone daily) during the FT596 dosing period.
Drug: FT596, Drug: Rituximab
NHL, Non Hodgkin Lymphoma, Diffuse Large B Cell Lymphoma, High-grade B-cell Lymphoma
auto HSCT, Stem cell transplantation, Lymphoma
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University of Minnesota — Minneapolis, Minnesota

The Effect of Inflammation and Damage to Lymph Node Structures on Durable Protective Immunity Following Yellow Fever Vaccination

Timothy Schacker
schac008@umn.edu
All
18 Years to 60 Years old
Phase 1/Phase 2
This study is also accepting healthy volunteers
NCT04269265
STUDY00004946
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Inclusion Criteria:

• No contraindication to Yellow Fever vaccine (immunosuppressed for any reason or on an immunosuppressive drug where a live virus vaccine is contraindicated).
• If female of childbearing age must agree to contraception for one month following administration of the vaccination.
Exclusion Criteria:

• History of yellow fever or previous vaccination for yellow fever
• Known bleeding disorder
• Prior surgery complicated by clotting abnormality
• Psychiatric or behavioral disorder that, in the opinion of the investigator, will make it difficult for the participant to complete the study
• History of acute hypersensitivity reaction to any component of the vaccine (including gelatin, eggs, egg products, or chicken protein).
• Thymus disorder associated with abnormal immune function
• Immunosuppression from any of the following: HIV infection or AIDS, malignant neoplasms, primary immunodeficiencies, transplantation, transplantation, immunosuppressive or immunomodulatory therapy (corticosteroids, alkylating agents, antimetabolites, TNF inhibitors, IL-1 blocking agents, monoclonal antibodies targeting immune cells), previous radiation therapy.
• Pregnant or breastfeeding at the time of vaccination.
• Planning to conceive within 28 days of enrollment and vaccination with the yellow fever vaccine.
Biological: Yellow Fever Vaccine
Yellow Fever
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University of Minnesota — Minneapolis, Minnesota Timothy Schacker, MD - (olso7966@umn.edu)

A Study of the Drug Letermovir (LTV) as Prevention for Recurrent of Cytomegalovirus (CMV) Infection

This is an open-label single arm trial of letermovir (LTV, Prevymis) for prevention of recurrent CMV infection in allogeneic hematopoietic cell transplantation (HCT) recipients with history of CMV infection. The study is being conducted at MSKCC and at the University of Minnesota. Thirty-six HCT recipients who are ≥12 years of age, had clinically significant CMV infection treated with CMV antivirals and are at high risk for recurrent CMV infection, defined as receiving a transplant from an HLA mismatched donor (including cord blood), acute or chronic graft versus host disease (GVHD) requiring either topical and/or systemic steroid treatment within 14 days prior to enrollment, or T cell-depleted (CD34+-selected) allograft, will be eligible to participate in the study.

Jo-Anne Young, MD
vanbu004@umn.edu
All
12 Years and over
Phase 2
This study is NOT accepting healthy volunteers
NCT04017962
STUDY00011646
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Inclusion Criteria:

• Age >/= 12 years (any weight)
• Have received allogenic HCT
• Have received preemptive therapy for clinically significant CMV infection post-HCT and have completed preemptive therapy no longer than 7 days prior to enrollment. Preemptive treatment includes ganciclovir, valganciclovir, foscarnet or cidofovir. Clinically significant CMV infection is defined as CMV viremia requiring preemptive therapy or CMV EOD. Patients who have received LTV prophylaxis prior to onset of clinically significant CMV infection prior to enrollment (see also exclusion criteria below).
• Have one or more risk factors for recurrent CMV infection: 1. Human leukocyte antigen (HLA) mismatch
• HLA-related (sibling) donor with at least one mismatch at the HLA-A, -B or -DR gene loci
• Haploidentical donor
• Unrelated donor with at least one mismatch at the HLA-A, -B, -C or -DRC1gene loci, or
• Cord blood as stem cell source 2. Acute or chronic GVHD requiring either topical steroids for gastrointestinal GVHD and/or systemic steroid treatment (>/= 1mg/kg/day of prednisone or equivalent dose of another corticosteroid) within 14 days prior to enrollment 3. T-cell-depleted allograft
• For adult patients, able to provide written consent and complete the informed consent. For patients under 18 years, the patient's parent(s) or legal guardian(s) must provide informed consent and the patient must provide written assent to participation in the study.
• Willing and able to comply with trial instructions and requirements
• Male and female patients of childbearing potential must be willing to use a highly effective method of contraception for the course of the study. Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the patient. Subject eligibility criteria for the observational cohort:
• Age 18 years or older
• First allogenic peripheral blood or marrow HCT
• LTV prophylaxis starting <30 days post HCT and given for at least 6 weeks
• T-cell count >/=100 at day +100
Exclusion Criteria:

• Clinically significant CMV infection present at enrollment
• Breakthrough CMV infection while on primary LTV prophylaxis (unless patient non-adherent or unable to adequately absorb letermovir or presence of documented resistance to LTV.
• Glomerular filtration rate (GFR) • Severe hepatic impairment (Child Pugh C)
• Routine use of high-dose acyclovir (doses of > 800 mg twice daily), valacyclovir (doses of > 500mg twice daily), or famciclovir (doses > 500mg/day) for varicella zoster virus (VZV)/herpes simplex virus prophylaxis; limited treatment courses at higher doses for VZV infections are permissible if treatment duration dose not exceed 14 days total. Short courses of IV cidofovir for adeno virus (ADV) are permissible
• Suspected or known hypersensitivity to active or inactive ingredients of LTV formulations
• Patients treated with a medication whose administration with LTV is ontraindicated and whose discontinuation is not possible. Contraindicated medications include pimozide, ergot alkaloids and pitavastatin or simvastatin when co-administered with cyclosporine.
• Imminent demise (expected survival <6 weeks)
• Documented positive result for human immunodeficiency virus antibody (HIV-Ab) or for hepatitis C virus antibody (HCV-Ab) with detectable HCV RNA, or hepatitis B surface antigen (HBsAg) at any time prior to HCT
• Need for mechanical ventilation and/or vasopressor support at the time of enrollment
• Pregnancy or breastfeeding
• Plans to conceive or father children within the projected duration of the trial
• History of current evidence of any condition, therapy, lab abnormality, or other circumstance that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or would place the subject at undue risk as judged by the investigator, such that it is not in the best interest of the subject to participate in this study. Exclusion criteria for observational cohort:
• Clinically significant CMV infection during the 100 days following HCT. Clinically significant CMV infection defined as either CMV viremia requiring preemptive therapy with CMV antivirals or CMV end organ disease (EOD)
• Grade 3-4 GVHD
• Cord blood as cell source for HCT
• Treatment with systemic steroids (>0.5mg/kg for 2 weeks or longer) prior to enrollment
Drug: Letermovir Pill, Other: blood draw
CMV, CMV Infection, Hematopoietic Cell Transplant
HCT, CMV infection, Letermovir, LTV, Memorial Sloan Kettering Cancer Center, 19-174
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University of Minnesota — Minneapolis, Minnesota Jo-Anne Young, MD

The ACT Trial: Effects of Combined Aerobic Exercise and Cognitive Training in MCI

This study will be a multi-site, single-blinded, randomized controlled trial (RCT) that will screen older adults with mild cognitive impairment (MCI) using 4 steps (over the phone, in-person interview including informed consent, medical verification, exercise stress test/magnetic resonance imaging [MRI]). We will enroll 128 participants (target 96 completers, assuming 25% attrition rate at 6 months). After baseline assessment, participants will be enrolled and randomized within age (65-74 years of age or ≥75 years of age) and study site (Minnesota or Rochester) strata centrally at the University of Minnesota (UMN) to one of four groups: ACT, cycling only, SOP only, or control with equal allocation and using a randomization scheme generated by our UMN biostatistician (CI: Vock). Group allocations will be concealed to all investigators and data collectors. The interventions will last for 6 months with 12-month follow-up. Outcomes include: 1) cognition: composite measures of executive function and episodic memory, 2) AD signature cortical thickness: composite using structural magnetic resonance imaging (MRI), 3) functional connectivity in DMN: resting-state using functional MRI (fMRI), 4) aerobic fitness, and 5) clinical and pathological AD conversion. Cognition and aerobic fitness will be assessed at baseline, 3, 6, 12, and 18 months; AD conversion at 6, 12, and 18 months; and AD signature cortical thickness and DMN at baseline, 6, 12, and 18 months. PIs Yu and Lin have developed and tested strategies in their preliminary studies to successfully ensure the protection of human participants.

Dereck Salisbury
salis048@umn.edu
All
65 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT03313895
STUDY00001135
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Inclusion Criteria:

• A clinical diagnosis of MCI, Community-dwelling, Age 65 years and older, English-speaking, Adequate visual acuity, Verified exercise safety by medical provider, Stable on drugs affecting cognitive and psychological status, Verified MRI safety, and Capacity to consent.
Exclusion Criteria:

• Geriatric Depression Scale < 5, Resting heart rate (HR) ≤50 due to arrhythmia or ≥100 beats/min, Neurological (e.g., dementia, head trauma), psychiatric (e.g., bipolar, schizophrenia, or depression), or substance dependency (alcohol or chemical dependency) in the past 5 years that are the main contributor to MCI, Contraindications to exercise, e.g. unstable angina, recent surgery, New symptoms or diseases that have not been evaluated by a health care provider, Current enrollment in another intervention study related to cognitive improvement (reduce confounding effects on outcomes), and Abnormal MRI findings.
Behavioral: ACT, Behavioral: Cycling Only, Behavioral: Cognitive Training Only, Behavioral: Stretching and Mental Stimulating Activities
Mild Cognitive Impairment
cognitive impairment, Alzheimer's disease, exercise, cognitive training, imaging
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University of Minnesota — Minneapolis, Minnesota Russell Spafford, MS - (spaff010@umn.edu) Dereck Salisbury, PhD - (salis048@umn.edu)

Effect of N-803 on B Cell Follicles in Antiretroviral Treated HIV Disease

The primary objectives of this study are: -To determine the impact of N-803 on the frequency and function of CD8+ T cells in B cell follicles. -To determine the safety of N-803 HIV+ ART suppressed individuals by assessment of adverse events experienced by participants during the conduct of the trial.

Timothy Schacker
schac008@umn.edu
All
18 Years to 65 Years old
Phase 1
This study is NOT accepting healthy volunteers
NCT04808908
STUDY00007810
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Inclusion Criteria:

• HIV-1 infection, documented by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 antigen or plasma HIV-1 RNA viral load.
• On continuous antiretroviral therapy for over 24 months without any interruptions of greater than 14 consecutive days, without plans to modify ARTduring the study period.
• Screening plasma HIV RNA levels < 20 copies/mL and on at least 1 determination in past 12 months (isolated single values greater than or equal to 20 but < 200 copies/mL will be allowed if they were preceded and followed by undetectable viral load determinations)
• Screening CD4+ T cell count greater than or equal to 350 cells/mm3 and nadir CD4+ T cell count of >200 per participant report.
• Ability to be off prednisone and other immunosuppressive drugs for at least 14 days before screen. Inhaled, nasal spray, and topical steroids are acceptable.
• Acceptable blood pressure and heart rate parameters within normal limits (systolic = 88-140mmHg; diastolic = 50-<90mmHg; heart rate = 46-100 bpm). Treatment with antihypertensive medication is allowed. However, if someone is on a beta-blocker this must be switched to another class of medication as there is a theoretical risk for bradycardia if the participant were to experience cytokine release syndrome symptoms (which has not happened with this drug delivered SQ).
• Sexually active females of child bearing potential and males with partners of child bearing potential must agree to use effective contraception during study participation and for 1 month following the final study visit (4 months after final dose of study drug). Acceptable birth control is defined as the following: (1) For female participants of childbearing potential, two of the following forms of contraception are required, one of which must be a barrier method: 1. Condoms (male or female) with or without a spermicidal agent 2. Diaphragm or cervical cap with spermicide 3. Intrauterine device (IUD) with published data showing that expected failure rate is < 1% per year 4. Tubal ligation 5. Hormone-based contraceptive such as oral birth control pills
• Laboratory tests performed within 14 days of study enrollment must be a grade 0 or 1 as defined by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, with the following exceptions: 1. Platelet counts (≥ 150,000/mm3) 2. Hemoglobin > 12.5 g/dL for men and > 11.5 g/dL for women. It is not acceptable for patients to be transfused to meet this requirement. The use of Epogen is permitted. 3. Estimated Cr Cl (eGFR) > 50
Exclusion Criteria:

• Active or recent malignancy requiring systemic chemotherapy or surgery in the preceding 36 months or for whom such therapies are expected in the subsequent 12 months; minor surgical removal of localized skin cancers (squamous cell carcinoma, basal cell carcinoma) are not exclusionary
• Chronic liver disease defined as Class B and C on the Child-Pugh chronic liver disease scale.
• Active and poorly controlled atherosclerotic cardiovascular disease (ASCVD), as defined by 2013 ACC/AHA guidelines, including a previous diagnosis of any of the following: 1. acute myocardial infarction 2. acute coronary syndromes 3. stable or unstable angina 4. coronary or other arterial revascularization 5. stroke 6. transient ischemic attack (TIA) 7. peripheral arterial disease presumed to be of atherosclerotic origin.
• History of potential immune-mediated medical conditions requiring concomitant treatment with immunomodulatory drugs, and/or exposure to any immunomodulatory drug in the 30 days prior to screen (e.g. corticosteroid therapy equal to or exceeding a dose of 15 mg/day of prednisone for more than 10 days, IL-2, interferon, methotrexate, cancer chemotherapy). NOTE: use of inhaled, nasal steroid or topical steroid lotions and creams is not exclusionary. Prior exposure to N-803 is not exclusionary if prior exposure occurred at least 6 months before screen.
• Unable to undergo leukapheresis procedure
• Exposure to any experimental therapies within 90 days of study screen. Exposure to long acting injectable ART therapies is not exclusionary.
• Latent TB infection or active TB disease prior to completing a standard regimen of anti-TB therapy that is defined as meeting PPD criteria for TB exposure or a positive quantiferon gold test collected at screening.
• Active fungal infection requiring systemic antifungal therapy
• Active herpes outbreak or varicella-zoster virus infection requiring episodic treatment
• Chronic active hepatitis B or C. For Hepatitis B this will be defined as HBs antigen + and for Hepatitis C this will be defined as Hepatitis C antibody positive and Hepatitis C PCR+.
• History and/or presence of any clinically significant disease or disorder, such as cardiovascular, pulmonary, renal, hepatic, neurological, gastrointestinal and psychiatric/mental disease/disorder, which, in the opinion of the site Principle Investigator may either put the subject at risk because of participation in the study, influence the results of the study or the subject's ability to participate in the study.
• Any degree of baseline QT/QTc interval prolongation (QTc interval > 450 msec in males and > 470 msec in females.)
• Any ischemic changes seen in the stress treadmill test administered per the discretion of the PI in order to assess any other EKG abnormalities outlined in study protocol
• History or evidence of uncontrollable CNS disease such as dementia, demyelinating disease, Parkinson's, or a CNS degenerative disease that, in the opinion of the site Principle Investigator, may either put the subject at risk because of participation in the study, influence the results of the study or the subject's ability to participate in the study.
• Prior organ allograft or allogeneic transplantation
• Planning or current pregnancy or breastfeeding
• Any clinically indicated vaccination (other than influenza) administered within 14 days of screen
Biological: N-803
Hiv, HIV Infections, AIDS
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Hennepin County Medical Center — Minneapolis, Minnesota Kelly Garcia-Myers
University of Minnesota — Minneapolis, Minnesota Kristin Boman

Improving Outcome for Family Caregivers of Older Adults With Complex Conditions: The Adult Day Plus (ADS Plus) Program (ADS Plus)

To evaluate the efficacy of ADS Plus, a family-based intervention program, in 30 adult day service programs throughout the United States among 240 family caregivers over a 12-month evaluation period.

All
21 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT02927821
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Inclusion Criteria:
Caregivers are eligible to participate at time of intake at an Adult Day Service (ADS) if they:
• are initially enrolling their relative in one of the 30 participating ADS sites
• expect to use ADS for a minimum of 1 week for 6 months
• have primary responsibility for care of the ADS client
• speak English
• provided > 8 hours of assistance to client in past week
• have a telephone and are willing to participate in 4 telephone interviews (baseline, 3 month check-in; 6 and 12 month follow-ups)
• are 21 years of age or older (male or female).
Exclusion Criteria:
caregivers and older adult clients are not eligible if:
• they plan to move from the area within 6 months
• either caregiver or client has been hospitalized >3 times in past year
• either caregiver or client is in active treatment for a terminal illness or are in hospice
• caregiver is involved in other caregiver support services/trials.
Behavioral: ADS Plus
Stress
Adult Day Care Centers, Caregivers
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University of Minnesota — Minneapolis, Minnesota Joseph Gaugler, PhD - (gaug0015@umn.edu)

Brivaracetam to Reduce Neuropathic Pain in Chronic Spinal Cord Injury

This clinical trial will determine if the drug Brivaracetam will reduce neuropathic pain in individuals with spinal cord injuries.

Leslie Morse
morsel@umn.edu
All
18 Years and over
Phase 1/Phase 2
This study is NOT accepting healthy volunteers
NCT04379011
STUDY00010959
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Inclusion Criteria:

• Spinal cord injury (SCI)
• Participants must have completed inpatient rehabilitation and are living in the community
• Participant who have severe below-level neuropathic pain (daily average 9/10 or 10/10)
• Participants must have tried and failed to achieve adequate pain relief with the use of other drugs (i.e treatment failed to decrease their pain below a level of 9) and can continue to take spasmolytics, pregabalin, gabapentin, and opioids in unchanged dosing throughout the trial
Exclusion Criteria:

• Pprogressive myelopathy secondary to posttraumatic cord tethering
• Syringomyelia
• Brain injury limiting the ability to follow directions
• Pregnancy or lactation
• Epilepsy
• Impaired liver or renal function
• Contraindications to brivaracetam or pyrrolidine derivatives including allergy, or contraindications to MRI including retained bullet fragments, noncompatible metal implants, and implanted devices such as baclofen pumps
Drug: Brivaracetam, Other: Placebo
Spinal Cord Injuries
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University of Minnesota School of Medicine — Minneapolis, Minnesota Leslie R Morse, DO - (morsel@umn.edu) Nguyen Nguyen, MPH - (nguy4139@umn.edu)

FRESH-TEEN: Families Responsibility Education Support Health for Teens (FRESH-TEEN)

The two primary aims of the study are: -To evaluate the efficacy of PEER and BWL on the target adolescent’s weight over the 18 months of the study, and -To evaluate the efficacy of PEER and BWL on the target adolescent’s emotion regulation skills and emotional eating over the 18-months of the study.

Carol Peterson
peter161@umn.edu
All
13 Years to 16 Years old
N/A
This study is NOT accepting healthy volunteers
NCT03674944
STUDY00003419
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Inclusion Criteria:

• Adolescent age 13-16 years
• BMI percentile 85%85%-99.9% (adolescent only)
• Ability to read English at a minimum 6th grade level (both adolescent and parent); and willing to participate in a 6-month treatment and all assessments (both adolescent and parent)
Exclusion Criteria:
1. Current enrollment in a weight management program (Child and Parent); 2. Medication that is specifically prescribed for weight loss (Child and Parent); 3. Medical or psychiatric condition that may interfere with treatment participation (Child and Parent); 4. Regular use of compensatory behavior for weight loss (e.g., purging) during the past six months (Child and Parent); 5. Current pregnancy or lactating (Child and Parent); 6. Change in psychotropic medication during the previous three months (Child and Parent).
Behavioral: Behavioral Weight Loss (BWL) + Emotion Regulation (ER), Behavioral: Behavioral Weight Loss (BWL)
Overweight and Obesity
Overweight, Obesity, Overeating, Treatment, Body Mass Index, Intervention, Behavioral Treatment, Dialectical Behavior Therapy, Emotion Regulation
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Ambulatory Research Center - University of Minnesota — Minneapolis, Minnesota Carol Peterson, Ph.D. - (peter161@umn.edu)

Evaluating a Healthy Restaurant Kids Meals Policy

All
18 Years and over
This study is also accepting healthy volunteers
NCT04330235
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Inclusion Criteria:

• Adult 18 years of age or older
• Parent or legal guardian of a child 2-10 years of age
• Purchasing at least one food or beverage item for the child at the restaurant (if purchasing foods or beverages for multiple children, only items purchased for the youngest child 2-10 years of age will be included)
• Able to speak and understand English or Spanish Additional criteria for dietary recalls:
• Parent or legal guardian 18 years of age or older is present for the recall
• If child for whom the restaurant meal was purchased is 6 years of age or older, child is present for the recall
• If child for whom the restaurant meal was purchased is 9 years of age or older, the child is present for the recall and is able to speak and understand English or Spanish
Exclusion Criteria:

• Younger than 18 years of age
• Is not a parent or legal guardian to a child 2-10 years of age
• Is not purchasing one or more food or beverage items for the child at the restaurant
• Does not speak or understand English or Spanish Additional criteria for dietary recalls:
• Parent or legal guardian is not present for the recall
• The restaurant meal was purchased for a child 6 years of age or older, who is not present for the recall
• Child 9 years of age or older, for whom the restaurant meal was purchased, is not able to speak or understand English or Spanish
Other: Healthy Default Kids' Beverage Policy
Diet Habit
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University of Minnesota — Minneapolis, Minnesota

Spinal Manipulation and Patient Self-Management for Preventing Acute to Chronic Back Pain (PACBACK)

The long-term objective is to reduce overall low back pain (LBP) burden by testing scalable, first-line, non-pharmacologic strategies that address the biopsychosocial aspects of acute/sub-acute LBP and prevent transition to chronic LBP. This is a novel randomized hybrid trial addressing both effectiveness and implementation. A total of 1180 patients will be enrolled with nonspecific LBP of 2-12 weeks duration, at medium or high risk of developing chronic LBP. This multi-site, predominantly pragmatic, phase III trial has two main aims. Aim 1 will assess the effectiveness of Spinal Manipulation Therapy (SMT), Supported Self-Management (SSM), and SMT+SSM relative to Medical Care (MC) in a randomized trial using a 2x2 factorial design. Aim 2 will use mixed methods to gather data about influences on the interventions that could affect interpretation of results and future implementation.

Gert Bronfort
bronf003@umn.edu
All
18 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT03581123
SITE00000150
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Inclusion Criteria:

• At least 18 years of age
• Acute or sub-acute low back pain
• Average low back pain severity ≥3 on the 0-10 numerical rating scale over 7 days
• Medium or high risk for persistent disabling back pain according to the STarT Back screening tool
• Ability to read and write fluently in English
Exclusion Criteria:

• Non-mechanical causes of low back pain
• Contraindications to study treatments (e.g,. surgical fusion of lumbar spine)
• Active management of current episode of low back pain by another healthcare provider
• Serious co-morbid health condition that either requires medical attention or has a risk for general health decline over the next year
• Pregnancy, current or planned during study period and nursing mothers
• Inability or unwillingness to give written informed consent
Behavioral: Supported-Self Management (SSM), Other: Spinal Manipulation Therapy (SMT), Combination Product: SMT + SSM, Drug: Standard Medical Care (SMC)
Acute Pain, Low Back Pain, Mechanical
acute/subacute low back pain, randomized clinical trial, self-management, behavioral modification, spinal manipulation therapy, standard medical care, secondary prevention
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University of Minnesota — Minneapolis, Minnesota Linda M Hanson, DC, MS - (hans4236@umn.edu)

Fatigue Management Programs for People With MS

Virgil Mathiowetz, PhD
mathi003@umn.edu
All
18 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT03550170
STUDY00003959
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Inclusion Criteria:

• Self-report diagnosis of MS
• Age ≥ 18 years
• Fatigue Severity Scale score ≥ 4
• Ability to speak English
Exclusion Criteria:

• Individual must be capable of providing consent (Assessed with questionnaire)
• Unable to access the internet or unable to travel to in-person sessions
Behavioral: Teleconference, Behavioral: Internet, Behavioral: 1-to-1, in-person
Multiple Sclerosis
Fatigue, Wellness, Multiple Sclerosis, Quality of life
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University of Minnesota — Minneapolis, Minnesota Virgil Mathiowetz, PhD - (mathi003@umn.edu)

Sacral Nerve Stimulation in Improving Bladder After Acute Traumatic Spinal Cord Injury

We propose the following research plan to demonstrate the utility of Sacral Neuromadulation (SNM) in acute spinal cord injury (SCI) with regard to neurogenic bladder outcomes: (1) to determine the effect of sacral neuromodulation on urodynamic parameters in the setting of acute spinal cord injury, (2) to assess the impact of sacral neuromodulation on patient-reported quality of life after acute spinal cord injury, and (3) to examine the impact of sacral neuromodulation on quantifiable clinical outcomes. (1) In a multicenter clinical trial, patients will be randomized to receive bilateral SNM devices versus control observation with standard of care medications and interventions. Success of the procedure will be determined with urodynamic parameters including maximum cystometric capacity, volume and pressure at first detrusor contraction, bladder compliance and presence of detrusor overactivity. (2) Patient quality of life will be assessed using the validated SCI-QOL bladder question bank. (3) Patients will be followed longitudinally and assessed for clinically important outcomes such as urinary incontinence, hospitalizations, need for anti-cholinergic medications, and number of symptomatic UTIs per year. Complications attributable to the device and need for device revision will be assessed longitudinally as well.

All
18 Years to 100 Years old
N/A
This study is also accepting healthy volunteers
NCT03083366
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Inclusion Criteria:

• Age > 18 years
• Ability to implant device less than 12 weeks post-SCI
• Presence of acute SCI at or above T12
• ASIA Scale A or B
• Expectation to perform CIC personally or have caretaker perform CIC
Exclusion Criteria:

• Inability to perform CIC
• Pre-existing SCI
• Pre-existing progressive neurological disorder
• Autonomic dysreflexia
• Prior sacral back surgery
• Posterior pelvic fracture with distortion of the sacroiliac joint
• Prior urethral sphincter or bladder dysfunction
• Chronic urinary tract infections prior to SCI
• Pregnancy at the time of enrollment
• Presence of coagulation disorder or need for anticoagulation that they cannot be stopped temporarily for procedure
• Any significant co-morbidity or illness that would preclude their participation or increase the risk to them having a surgical procedure
• Active untreated infection
• Traumatic injury to the genitourinary system
• Prior pelvic radiation, bladder cancer or other surgical procedure to the bladder that would effect baseline bladder physiology
Device: PrimeAdvanced Surescan 97702 Neurostimulator - Medtronic (Minneapolis, MN)
Spinal Cord Injury, Acute, Neurogenic Bladder, Incontinence, Urinary Tract Infections
spinal cord injury, Neurogenic, bladder, electrical stimulation, neuromodulation
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University of Minnesota — Minneapolis, Minnesota Kelly Ayd, BS - (plan0067@umn.edu)

UrApp for Childhood Nephrotic Syndrome Management (Incident Cohort)

Michelle Rheault
rheau002@umn.edu
All
18 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT04075656
STUDY00006828
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Inclusion Criteria:

• caregivers of patients ages 1-17 with steroid sensitive NS diagnosed within 42 days at time of enrollment
• ownership of a functioning iPhone
• access to WIFI/internet
• proficiency with the English language
Exclusion Criteria:

• end-stage kidney disease
• renal transplantation
• clinical or histologic evidence of secondary NS (e.g., systemic lupus erythematosus)
Behavioral: Standard of Care, Behavioral: UrApp
Idiopathic Nephrotic Syndrome
Pediatrics, mHealth, Behavioral intervention
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University of Minnesota Children's Hospital — Minneapolis, Minnesota

Pembrolizumab in Treating Participants With Recurrent Ovarian Cancer

To evaluate clinical anti-tumor activity of pembrolizumab monotherapy based on ORR as assessed by the investigator per irRECIST in patients with ROC whose tumors show an immunoreactive gene expression signature

Boris Winterhoff
bwinterh@umn.edu
Female
18 Years and over
Phase 2
This study is NOT accepting healthy volunteers
NCT03732950
STUDY00006054
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Inclusion Criteria:

• Be willing and able to provide written informed consent/assent for the trial
• Have received 1-5 prior lines for treating ROC (i.e. 2-6 total prior lines counting the front line) and must have a platinum-free interval (PFI) or a treatment-free interval (TFI) >= 3 months based on the last regimen received
• Have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
• Note: Tumor lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions
• Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) performance scale
• Have histologically diagnosed recurrent epithelial ovarian, fallopian or primary peritoneal ovarian cancer
• Have provided a tumor tissue sample either collected from a newly obtained tumor tissue biopsy or an archival tissue specimen. Subjects for whom newly obtained samples cannot be provided (e.g. inaccessible or subject safety concern) may submit an archived biopsy specimen. Formalin-fixed paraffin embedded (FFPE) block specimens are preferred to 20 unstained slides. Additional samples may be requested if tumor tissue provided is not adequate for quality and/or quantity as assessed by the central laboratory
• Performed within 10 days of treatment initiation: absolute neutrophil count (ANC) >= 1,500/mcL
• Performed within 10 days of treatment initiation: platelets >= 100,000/mcL
• Performed within 10 days of treatment initiation: hemoglobin >= 9 g/dL or >= 5.6 mmol/L without transfusion or erythropoietin (EPO) dependency (within 7 days of assessment)
• Performed within 10 days of treatment initiation: serum creatinine OR measured or calculated creatinine clearance (CrCl) (glomerular filtration rate [GFR] can also be used in place of creatinine or CrCl) =< 1.5 x upper limit of normal (ULN) OR >= 45 mL/min for subject with creatinine levels > 1.5 x institutional ULN
• Creatinine clearance should be calculated per institutional standard
• Performed within 10 days of treatment initiation: serum total bilirubin =<1.5 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
• Performed within 10 days of treatment initiation: aspartate aminotransferase (AST) (serum glutamate pyruvate transaminase [SGOT]) and aspartate aminotransferase (ALT) (serum glutamic-oxaloacetic transaminase [SGPT]) =< 2.5 x ULN OR =< 5 x ULN for subjects with liver metastases
• Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
• Have received front line platinum-based chemotherapy (preoperative chemotherapy is allowed)
• Female subjects of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study medication
• Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
Exclusion Criteria:

• Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 2 weeks of the first dose of treatment
• Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment
• Has a known history of active TB (Bacillus Tuberculosis)
• Hypersensitivity to pembrolizumab or any of its excipients
• Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study day 1 or who has not recovered (i.e., =< grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier
• Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study day 1 or who has not recovered (i.e., =< grade 1 or at baseline) from adverse events due to a previously administered agent
• Note: Subjects with =< grade 2 neuropathy are an exception to this criterion and may qualify for the study
• Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy
• Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer
• Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability
• Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment
• Has known history of, or any evidence of active, non-infectious pneumonitis
• Has an active infection requiring systemic therapy
• Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject?s participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator
• Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
• Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment
• Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent
• Has a known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies)
• Has known active hepatitis B (e.g., hepatitis B surface antigen [HBsAg] reactive) or hepatitis C (e.g., hepatitis C virus [HCV] ribonucleic acid [RNA] [qualitative] is detected)
• Has received a live vaccine within 30 days of planned start of study therapy
• Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist) are live attenuated vaccines, and are not allowed
Biological: Pembrolizumab
Recurrent Fallopian Tube Carcinoma, Recurrent Ovarian Carcinoma, Recurrent Primary Peritoneal Carcinoma
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University of Minnesota/Masonic Cancer Center — Minneapolis, Minnesota Erin E. Zielinski - (eezielin@umn.edu)

Neoadjuvant Combination Targeted and Immunotherapy for Patients With High-Risk Stage III Melanoma (NeoACTIVATE)

To estimate the percentage of patients with stage III BRAFm melanoma that achieves a pathologic complete response after 12 weeks of neoadjuvant vemurafenib/cobimetinib/atezolizumab. To estimate the percentage of patients with stage III BRAFwt melanoma that achieves a pathologic complete response after 12 weeks of neoadjuvant cobimetinib/atezolizumab. Adjuvant phase primary objectives: To assess recurrence-free survival (RFS) in patients with stage III BRAFm melanoma after neoadjuvant vemurafenib/cobimetinib/atezolizumab, surgery, and adjuvant atezolizumab. To assess RFS in patients with stage III BRAFwt melanoma after neoadjuvant cobimetinib/atezolizumab, surgery, and adjuvant atezolizumab.

Evidio Domingo Musibay
musib024@umn.edu
All
18 Years and over
Phase 2
This study is NOT accepting healthy volunteers
NCT03554083
STUDY00004666
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Inclusion Criteria:

• PRE-REGISTRATION: High-risk stage III melanoma, defined as (any of the following):
• Recurrent nodal metastasis, or
• Clinically detectable nodal metastasis, or
• Metastatic involvement of more than one nodal basin
• NOTE: For the purpose of pre-registration, high-risk stage III melanoma is defined based on clinical and imaging assessment (positron emission tomography/computed tomography [PET/CT], CT, or magnetic resonance imaging [MRI]). Histologic confirmation of nodal metastatic disease is not needed at the time of pre-registration, provided there is histologic confirmation of primary melanoma or a prior lymph node metastasis.
• PRE-REGISTRATION: Willing to submit archival tissue from a lymph node biopsy or undergo a needle biopsy for BRAF testing and for research purposes.
• PRE-REGISTRATION: Willing to forego anticancer treatments or investigational agents during pre-registration period.
• PRE-REGISTRATION: The following laboratory values obtained =< 28 days prior to pre-registration:
• Only for patients receiving therapeutic anticoagulation: stable anticoagulant regimen and stable international normalized ratio (INR).
• REGISTRATION: Histologic confirmation of stage III melanoma, as defined by the American Joint Committee on Cancer, 8th revised edition.
• REGISTRATION: Documentation of BRAFV600 mutation status in melanoma tumor tissue (archival or newly obtained) through use of a Clinical Laboratory Improvement Amendments (CLIA)-approved clinical mutation test.
• REGISTRATION: Surgically resectable disease, as determined by a melanoma surgical oncologist.
• REGISTRATION: Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• REGISTRATION: Life expectancy >= 26 weeks.
• REGISTRATION: Absolute neutrophil count (ANC) >= 1500/mm^3 obtained =< 14 days prior to registration.
• REGISTRATION: Platelet count >= 100,000/mm^3 obtained =< 14 days prior to registration.
• REGISTRATION: Hemoglobin >= 9.0 g/dL obtained =< 14 days prior to registration.
• REGISTRATION: Direct bilirubin =< institutional upper limit of normal (ULN) obtained =< 14 days prior to registration.
• REGISTRATION: Aspartate transaminase (AST) and alanine transaminase (ALT) =< 2 x ULN obtained =< 14 days prior to registration.
• REGISTRATION: Alkaline phosphatase < 2.5 x ULN obtained =< 14 days prior to registration.
• Creatinine =< 1.5 x ULN or creatinine clearance (CrCl) >= 40 mL/min on the basis of measured CrCl from a 24-hour urine collection or Cockcroft-Gault glomerular filtration rate estimation obtained =< 14 days prior to registration.
• REGISTRATION: Left ventricular ejection fraction (LVEF) >= 50% or institutional lower limit of normal (LLN) =< 6 months prior to registration.
• REGISTRATION: Average corrected QT interval (QTc) =< 450 ms on triplicate 12 lead electrocardiography (ECG) =< 28 days prior to registration.
• REGISTRATION: Negative pregnancy test done =< 7 days prior to registration, for persons of childbearing potential only.
• REGISTRATION: For persons of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use a contraceptive method with a failure rate of < 1% per year during the treatment period and for 6 months after the last dose of study treatment.
• REGISTRATION: For persons able to father a child: agreement to remain abstinent (refrain from heterosexual intercourse with a person of childbearing potential) or use contraceptive measures, and agreement to refrain from donating sperm.
• REGISTRATION: Provide written informed consent.
• REGISTRATION: Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study).
• REGISTRATION: Willing to provide tissue, blood, and stool samples for correlative research purposes.
Exclusion Criteria:

• PRE-REGISTRATION: Prior systemic anti-cancer therapy for melanoma (e.g., chemotherapy, hormonal therapy, targeted therapy, immunotherapy including anti-PD-1, anti-PDL1 agents, or other biologic therapies), with the following exceptions: adjuvant treatment with interferon, IL-2, granulocyte-macrophage colony-stimulating factor (GM-CSF) or vaccine therapies are allowed, if discontinued >= 28 days prior to pre-registration.
• PRE-REGISTRATION: Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm.
• PRE-REGISTRATION: For patients with concurrent diagnosis of primary melanoma with nodal involvement, major surgical procedure other than lymph node biopsy or wide local excision of primary melanoma =< 4 weeks prior to pre-registration, or anticipation of need for a major surgical procedure for reasons other than melanoma during the course of the study.
• PRE-REGISTRATION: For patients with nodal recurrence, surgical procedure or anti-cancer therapy for this recurrence (other than lymph node biopsy) or anticipation of need for a major surgical procedure for reasons other than melanoma during the course of the study.
• PRE-REGISTRATION: Prior radiotherapy for melanoma.
• PRE-REGISTRATION: History non-nodal melanoma metastasis or central nervous system (CNS) lesion(s) proven or clinically suspected to be metastasis.
• PRE-REGISTRATION: Active malignancy (other than melanoma) or malignancy =< 3 years prior to pre-registration.
• NOTE: with the exception of resected basal cell carcinoma (BCC), resected cutaneous squamous cell carcinoma (SCC), resected carcinoma in situ of the cervix, resected carcinoma in situ of the breast, in situ prostate cancer, non-muscle-invasive bladder cancer, or other curatively treated malignancies from which the patient has been disease-free for at least 3 years prior to pre-registration.
• PRE-REGISTRATION: Prior allogeneic stem cell or solid organ transplantation.
• PRE-REGISTRATION: History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan.
• PRE-REGISTRATION: History of autoimmune disease requiring systemic immunosuppressive or immune-modulatory therapy =< 5 years prior to pre-registration.
• PRE-REGISTRATION: Active psoriasis requiring therapy (systemic or topical).
• PRE-REGISTRATION: Known clinically significant liver disease, including alcoholism, cirrhosis, fatty liver, and other inherited liver disease as well as active viral disease.
• PRE-REGISTRATION: History of or evidence of retinal pathology on ophthalmologic examination including but not limited to:
• Neurosensory retinal detachment
• Central serous chorioretinopathy
• Retinal vein occlusion (RVO)
• Neovascular macular degeneration
• PRE-REGISTRATION: Immunocompromised patients and patients known to be human immunodeficiency virus (HIV) positive and currently receiving antiretroviral therapy.
• NOTE: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial.
• PRE-REGISTRATION: Uncontrolled intercurrent illness including, but not limited to:
• Ongoing or active infection
• Clinically significant cardiac dysfunction including:
• Symptomatic congestive heart failure defined as New York Heart Association class II or higher
• Unstable angina pectoris or new-onset angina =< 3 months prior to pre-registration
• Unstable cardiac arrhythmia
• Myocardial infarction =< 3 months prior to pre-registration
• Congenital long QT syndrome
• Clinically significant stroke, reversible ischemic neurological defect, or transient ischemic attack =< 6 months prior to pre-registration
• Any grade 3 hemorrhage or bleeding event =< 4 weeks prior to pre-registration
• Uncontrolled diabetes or symptomatic hyperglycemia
• Psychiatric illness/social situations that, in the judgement of the investigator, would a) limit compliance with study requirements, b) make the patient inappropriate for entry into this study, or c) interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens.
• PRE-REGISTRATION: Known hypersensitivity to biopharmaceutical agents produced in Chinese hamster ovary cells (example [ex]: recombinant follicle-stimulating hormone [FSH]).
• PRE-REGISTRATION: Known hypersensitivity to any components of the atezolizumab, cobimetinib, or vemurafenib formulations.
• PRE-REGISTRATION: History of severe allergic, anaphylactic or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins.
• REGISTRATION: Received anticancer treatments or investigational agents during pre-registration period.
• REGISTRATION: Clinically suspected non-nodal metastatic melanoma.
• REGISTRATION: For BRAF-mutant patients only: anticipated use of any concomitant medication =< 7 days prior to registration that is known to cause QT prolongation (which may lead to torsade de pointes).
• REGISTRATION: History of malabsorption or other clinically significant metabolic dysfunction that may interfere with absorption of oral study treatment or inability or unwillingness to swallow oral medication.
• REGISTRATION: Signs or symptoms of infection or has received antibiotics ≤14 days prior to registration.
• NOTE: Patients receiving prophylactic antibiotics (e.g., to prevent a urinary tract infection or chronic obstructive pulmonary disease exacerbation) are eligible for the study.
• REGISTRATION: Any of the following because this study involves investigational agents whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown:
• Pregnant persons
• Nursing persons
• Persons of childbearing potential who are unwilling to employ adequate contraception
• REGISTRATION: Treatment with a live, attenuated vaccine =< 4 weeks prior to registration, or anticipation of need for such a vaccine during the course of the study.
• REGISTRATION: Treatment with systemic immunosuppressive medication (including, but not limited to, prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor (TNF)-alpha agents) =< 2 weeks prior to registration, or anticipation of need for systemic immunosuppressive medication during the course of the study.
• NOTE: Patients who have received acute, low-dose systemic steroids (=< 10 mg/day oral prednisone or equivalent) prior to registration or a one-time pulse dose of systemic immunosuppressant medication (e.g., 48 hours of corticosteroids for a contrast allergy) are eligible for the study.
• NOTE: The use of inhaled corticosteroids for chronic obstructive pulmonary disease or asthma, mineralocorticoids (e.g., fludrocortisone), or low-dose corticosteroids for patients with orthostatic hypotension or adrenocortical insufficiency is allowed.
• REGISTRATION: Requirement for concomitant therapy or food that is prohibited during the study, or inability to abstain from alcohol during neoadjuvant phase.
Drug: Atezolizumab, Drug: Cobimetinib, Drug: Vemurafenib
Clinical Stage III Cutaneous Melanoma AJCC v8, Pathologic Stage III Cutaneous Melanoma AJCC v8, Pathologic Stage IIIA Cutaneous Melanoma AJCC v8, Pathologic Stage IIIB Cutaneous Melanoma AJCC v8, Pathologic Stage IIIC Cutaneous Melanoma AJCC v8, Pathologic Stage IIID Cutaneous Melanoma AJCC v8
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University of Minnesota/Masonic Cancer Center — Minneapolis, Minnesota Clinical Trials Office

Nivolumab With Ruxolitinib in Relapsed or Refractory Classical Hodgkin Lymphoma

This is a Phase I, multicenter, open-label, dose escalation study to evaluate the safety and tolerability of ruxolitinib when given with fixed dose nivolumab in patients with relapsed or refractory classical Hodgkin lymphoma (cHL). Up to 3 dose levels of ruxolitinib will be tested: 10 mg bid, 15 mg bid, and 20 mg bid. A dose level -1 of ruxolitinib 5 mg bid will be used only if dose level 1 proves too toxic. Participants will receive ruxolitinib at their assigned dose on a 28-day cycle with nivolumab 480 mg IV every 4 weeks until disease progression, unacceptable toxicity or for a maximum of 2 years. Cycle 1 only is expanded to 35 days to permit 1 week of ruxolitinib administration as a single agent before beginning every 4 week nivolumab. The dose escalation will use the continual reassessment method (CRM). The 1st 2 patients will enroll at dose level 1 (ruxolitinib 10 mg twice daily). The next cohort of 2 patients will not begin treatment until the last patient in the current cohort has reach day 35 after the 1st dose of ruxolitinib. Each new cohort of 2 patients will be assigned by the study statistician or designee at the same dose, 1 dose level higher, or 1 dose level lower. Once 10 patients are continuously enrolled at the same dose level, the MTD will be declared. Enrollment will continue at the MTD without staggering until a cumulative total of evaluable 20 patients are treated. Based on resources, the maximum number of allowable evaluable patients is 20. The simulations show it should be sufficient and safe to define the MTD for future efficacy trials. It is expected that 12 patients will be treated at the MTD. A sample size of 12 will achieve 79% power to detect a difference of ORR of 42% (equivalent of 5 responders) vs. null hypothesis of 12% using a two sided exact test with a significance level of 0.05. Participants will continue to receive the drugs until withdrawal criteria are met (e.g. toxicity, disease progression) or until 2 years duration of therapy.

Veronika Bachanova, MD
bach0173@umn.edu
All
18 Years and over
Phase 1/Phase 2
This study is NOT accepting healthy volunteers
NCT03681561
STUDY00001341
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Inclusion Criteria:

• Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
• Age ≥ 18 years at the time of consent.
• ECOG Performance Status of 0, 1 or 2.
• Histologically confirmed diagnosis of classical Hodgkin lymphoma that is relapsed or refractory
•historical biopsy at last relapse is acceptable. NOTE: a repeat biopsy is not required if the historical biopsy was performed at the most recent relapse, without remission in between.
• Presence of radiographically measurable disease (defined as the presence one or more ≥ 1.5 cm lesions, as measured in the longest dimension by PET/CT) within 4 weeks of study registration.
• Prior therapy with check-point inhibitors (nivolumab, pembrolizumab, others) and subsequent progressive disease, stable disease or mixed response
• Failed at least 2 prior therapies including cytotoxic chemotherapy including ABVD or similar, autologous transplantation, brentuximab vedotin, allogenic transplantation without active graft versus host disease Note: Patients who are eligible and willing to undergo autologous transplant should not be enrolled on this trial
• Prior cancer treatment must be completed at least 14 days prior to registration and the patient must have recovered from all reversible acute toxic effects of the regimen (other than alopecia) to ≤Grade 1 or baseline.
• Absolute Neutrophil Count ≥ 1000/μL
• Platelets ≥ 75,000/μL (or ≥50,000/mm3 if known BM involvement)
• Calculated creatinine clearance ≥ 40 cc/min using the Cockcroft-Gault formula
• Bilirubin ≤ 1.5 x upper limit of normal (ULN)
• Aspartate aminotransferase (AST) ≤ 2.5 × ULN
• Alanine aminotransferase (ALT) ≤ 2.5 × ULN
• Females of childbearing potential must have a negative serum pregnancy test within 7 days prior to registration. NOTE: Females are considered of child bearing potential unless they are surgically sterile (have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are naturally postmenopausal for at least 12 consecutive months
• Males who are sexually active with partners of child-bearing potential must be willing to abstain from heterosexual activity or adhere to contraception from the time of written consent until 7 months after treatment discontinuation.
• Patient must provide voluntary written informed consent prior to the performance of any research related tests or procedures.
Exclusion Criteria:

• Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study).
• Inability or unwillingness to swallow oral medication or any condition that precludes the administration and/or absorption of oral medications
• A life-threatening illness, medical condition or organ system dysfunction, which in the investigator's opinion, could compromise the patient's safety, interfere with the metabolism of study drugs, or put the study outcomes at undue risk
• Active central nervous system (CNS) involvement by lymphoma
• Uncontrolled cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction or any class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification
• Concomitant therapy with immunosuppressive agents, including systemic corticosteroids (doses ≤ 10 mg/day prednisone or equivalent are permitted).
• Has a history of autoimmune disease now or in past 3 years such as hepatitis, nephritis, hyperthyroidism, interstitial lung disease or colitis except vitiligo or alopecia, hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement or psoriasis not requiring systemic treatment
• HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of registration are eligible for this trial.
• Active Hepatitis B or C infection (defined as a positive Hepatitis B surface antigen (Ag) or detectable viral load by PCR). NOTES: Hepatitis B and C testing is required. Patients with positive Hepatitis B Ag may enroll if PCR is negative. Suppressive antiviral therapy should be considered for these patients as clinically indicated.
• Currently active, clinically significant hepatic impairment Child-Pugh class B or C
• Currently receiving a strong CYP3A4 Inhibitor (such as but not limited to boceprevir clarithromycin, conivaptan, grapefruit juice, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, mibefradil, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole) or Fluconazole >200 mg/day. Washout period of 1 week is required.
• History of stroke or intracranial hemorrhage within 6 months of study registration
Drug: Ruxolitinib, Drug: Nivolumab
Hodgkin Lymphoma
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Location Contacts
University of Minnesota — Minneapolis, Minnesota Erin Zielinski - (eezielin@umn.edu)