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Treatment of GVHD in Hematopoietic Stem Cell Transplant (HSCT) Recipients Using AAT Plus Corticosteroids (CS) Compared With Corticosteroids Alone

This study is a phase III, multicenter, double-blinded, randomized, placebo-controlled trial designed to compare AAT and corticosteroids (CS) to placebo and CS as first line therapy for patients with high-risk acute GVHD. The primary objective of this trial is to compare the rate of complete response (CR) and partial response (PR) on Day 28 post-randomization between AAT and CS versus placebo to match (PTM) and CS in patients with high-risk acute GVHD.

Najla El Jurdi
neljurdi@umn.edu
All
18 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT04167514
STUDY00007934
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Inclusion Criteria:

• Patients 18 years of age or older
• Initial presentation of acute GVHD after allogeneic hematopoietic cell transplantation for any indication
• Any graft or donor source or conditioning intensity
• Clinical diagnosis of acute GVHD requiring systemic therapy with corticosteroids
Exclusion Criteria:

• Prior exogenous AAT exposure for GVHD prophylaxis
• Relapsed, progressing, or persistent malignancy
• de novo chronic GVHD or overlap syndrome developing before or present at the time of enrollment
• Receiving other drugs for the treatment of GVHD
• Receiving systemic CS for any indication within 7 days before the onset of acute GVHD
Biological: Alpha-1 antitrypsin (AAT), Drug: Placebo
Graft Versus Host Disease (GVHD)
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University of Minnesota — Minneapolis, Minnesota Use Central Contact

SI Joint Stabilization in Long Fusion to the Pelvis (SILVIA)

Standard multilevel fusion surgery with fixation to pelvis using S2AI screws Same + use of iFuse-3D in the “bedrock” trajectory

Jonathan Sembrano
sembr001@umn.edu
All
21 Years to 75 Years old
N/A
This study is NOT accepting healthy volunteers
NCT04062630
STUDY00007463
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Inclusion Criteria:
1. Age 21-75 at time of screening 2. Patient scheduled for multilevel (>3 levels) spinal fusion surgery with planned fixation to the pelvis using S2AI screws 3. Patient has signed study-specific informed consent form 4. Patient has the necessary mental capacity to participate and is physically able to comply with study protocol requirements
Exclusion Criteria:
1. Indication for multilevel spine fusion surgery is any of the following: 1. Congenital neuromuscular disease 2. Prior pelvic fixation (i.e., patient already has S2AI or iliac bolts in place, current surgery indicated to revise this hardware) 3. Grade IV spondylolisthesis 2. Prior sacroiliac joint fusion/fixation on either side 3. Presence of spinal cord stimulator 4. Presence of severe hip pain that could impair functional and quality of life improvement from complex spine surgery 5. Surgeon plans to use iliac screw for pelvic fixation 6. Any known sacral or iliac pathology 7. Any condition or anatomy that makes treatment with the iFuse Implant System infeasible 8. Known metabolic bone disease 9. Severe osteoporosis 10. Known allergy to titanium or titanium alloys 11. Use of medications known to have detrimental effects on bone quality and soft-tissue healing 12. Neurologic condition that would interfere with postoperative physical therapy 13. Current local or systemic infection that raises the risk of surgery 14. Patient currently receiving or seeking short- or long-term worker's compensation and/or currently involved in injury litigation related to the SI joint or low back pain. 15. Currently pregnant or planning pregnancy in the next 2 years 16. Prisoner or a ward of the state. 17. Known or suspected drug or alcohol abuse 18. Uncontrolled psychiatric disease that could interfere with study participation 19. Fibromyalgia
Device: iFuse 3-D in Bedrock Configuration, Procedure: Multilevel Lumbar Fusion surgery
Sacroiliac Joint Disruption, Scoliosis Lumbar Region
Adult Scoliotic Spinal Deformity, Sacroiliac joint pain, multilevel lumbar surgery, SI Joint pain
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University of Minnesota — Minneapolis, Minnesota Christopher Martin, MD - (mart1865@umn.edu) Allison Wolf - (wolfx494@umn.edu)

Evaluation of Stool Based Markers for the Early Detection of Colorectal Cancers and Adenomas

The purpose of this study if to determine if stool or blood can be used to detect colon cancers as early or earlier than colonoscopy. The researchers plan to use these samples to learn about specific proteins (also known as biomarkers) that may indicate colon polyps, colon cancer or an increased risk of developing colon cancer. In order to learn more about preventing and detecting colon and rectal cancer, we are collecting samples from subjects with cancer, adenomas, and colonoscopies who may be at risk for polyps.

Aasma Shaukat
shaukat@umn.edu
All
18 Years and over
This study is NOT accepting healthy volunteers
NCT00843375
STUDY0006174
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Inclusion Criteria:

• Willing to sign informed consent
• Able to physically tolerate removal of up to 60 ml of blood
• Adults at least 18 years old
• Willing to collect 1-2 stool samples and prepare a Fecal Immunochemical Test (FIT)
• Pregnant or nursing women who otherwise meet the eligibility criteria may participate
• Subjects with one of the following:
• Colorectal adenocarcinoma-not treated and in colon at time of stool collection (CRC bin)
• Adenoma-pathologically confirmed adenoma present in colon at time of stool collection (Adenoma Bin)
• Higher Risk Normal Bin
• Subjects with a personal history of adenomas (confirmed by pathology) with none present on qualifying colonoscopy
• Subjects with a personal history of CRC (longer than 3 years ago because of exclusion criteria of cancer within last 3 years) with none present at time of qualifying colonoscopy
• Any family history of CRC (1st degree relative)
• Normal Control Bin
• No history or current finding of any colon neoplasia including CRC, adenomas, no personal or family history of HNPCC or FAP
• Subjects who had CRC that was successfully treated at least three years ago may be considered eligible for the adenoma bin if their polyps are adenomas and there is no evidence of CRC or for the higher risk normal bin as noted above.
• Subjects whose screening colonoscopy shows any of these types of polyps may be included in the normal or the higher risk normal bin if they meet the other criteria noted above.
• Hyperplastic polyps
• Benign mucosal polyps
• Polypoid granulation tissue
• Prolapsed mucosal polyps
• Inflammatory polyp
• Transitional mucosal polyp
• Lipoma
• Gangleoneuroma
• Neuroma
• Hamartomatous polyp
Exclusion Criteria:

• Cancer patients who have had any surgery, radiation, or chemotherapy for their current colorectal cancer prior to collecting the baseline samples
• Patients with a history of or clinically active Inflammatory Bowel Disease
• Patients with known HNPCC or FAP
• Inability to provide informed consent.
• Other active malignancy within 3 years of enrollment except any of the following:
• Squamous cell carcinoma of the skin
• Basal cell carcinoma of the skin
• Carcinoma in situ of the cervix, Stages Ia or Ib invasive squamous cell carcinoma of the cervix treated by surgery only. (Excluded if had pelvic radiation)
• Stage Ia Grade 1 adenocarcinoma of the endometrium treated with surgery
• Subjects with known HIV or chronic viral hepatitis
Colonic Neoplasms
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University of Minnesota — Minneapolis, Minnesota

Evaluating Effectiveness and Long Term Safety of Damoctocog Alfa Pegol in Patients, Who Have Been Diagnosed With Hemophilia A (HEM-POWR)

Multinational, open-label, prospective, non-interventional, multicenter, cohort study. The objectives of this study are to assess the effectiveness and long term safety of prophylaxis with damoctocog alfa pegol in the real-world setting through the collection of total bleeding events and analysis of the annualized bleeding rate (ABR) in the different prophylaxis regimens (following approved local label or any other regimen prescribed by the physician as part of normal clinical practice) in patients with hemophilia A. The analyses will be stratified, based on severity of hemophilia, severity of patient bleeding profile, disease characteristics, prophylaxis regimen, age, and time on treatment (i.e., damoctocog alfa pegol-naive or not).

Joan Beckman
beckm092@umn.edu
All
Not specified
This study is NOT accepting healthy volunteers
NCT03932201
STUDY00006977
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Inclusion Criteria:

• Diagnosis of hemophilia A.
• Patients previously treated for Hemophilia A.
• Patients without previous history of inhibitors or patients with previous history of inhibitors on standard prophylaxis therapy for at least 1 year prior to study entry.
• No current evidence of FVIII inhibitor or clinical suspicion of FVIII inhibitor.
• Initiation of or currently on damoctocog alfa pegol with any kind of treatment modality (on-demand, prophylaxis, or intermittent prophylaxis).
• Signed informed consent/assent.
Exclusion Criteria:

• Concurrent participation in an investigational program with interventions outside of routine clinical practice.
• Diagnosis of any other bleeding/coagulation disorder other than hemophilia A.
• Contra-indications according to the local marketing authorization.
• Patient on immune tolerance induction (ITI) treatment at the time of enrollment.
Drug: Damoctocog alfa pegol (Jivi, Bay94-9027)
Hemophilia A
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Regents of University of Minnesota — Minneapolis, Minnesota

Clinical Transplant-Related Long-term Outcomes of Alternative Donor Allogeneic Transplantation (BMT CTN 1702)

Claudio Brunstein, MD
bruns072@umn.edu
All
Not specified
N/A
This study is NOT accepting healthy volunteers
NCT03904134
STUDY00006361
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Inclusion Criteria:
Patients fulfilling the inclusion criteria will be eligible for enrollment in this study. Of those who consent, only patients who lack a suitable HLA-identical or 1 allele or antigen mismatched related donors are evaluable. Patients with an HLA-identical sibling or 1 allele or antigen mismatched family member donor are evaluable as long as the center deems the family member donor as unsuitable for other reasons. Patients may co-enroll with other interventional or observational studies. 1. Patients of all ages with AML, ALL, MDS, NHL, HL, AA, or SCD are eligible. 2. Any planned conditioning regimen and GVHD prophylaxis approach is eligible. 3. Patients must be considered suitable allogeneic transplant candidates at the time of enrollment based on medical history, physical examination, and available laboratory tests. Specific testing for organ function is not required for eligibility but, if available, these tests should be used by the treating physician to judge transplant suitability. 4. Patient and physician must intend to proceed with allogeneic HCT within the next 6 months if a suitable donor is identified. 5. Center plans to follow the algorithm for alternative donor identification: (a) for subjects who are Very Likely to find a MUD, attempt to identify a matched unrelated donor; (b) for a subjects who are Very Unlikely to find a MUD, proceed expeditiously to a haploidentical, cord blood or mismatched unrelated donor. 6. Signed informed consent, and assent if applicable. Consent may be signed prior to completion of family typing but patients will only be considered evaluable upon confirmation that there is no suitable HLA-identical or 1 allele or antigen mismatched related donor available.
Exclusion Criteria:
1. Prior allogeneic HCT (prior autologous transplant is allowed) 2. Previous formal unrelated donor search
Other: Donor Search Prognosis Score
Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndromes, Non-hodgkin Lymphoma, Hodgkin Lymphoma, Acquired Aplastic Anemia, Sickle Cell Disease
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University of Minnesota — Minneapolis, Minnesota Claudio Brunstein, MD, PhD - (bruns072@umn.edu) Jenna Johnson - (joh03025@umn.edu)

A Prospective, Multi-center, Randomized Controlled Blinded Trial Demonstrating the Safety and Effectiveness of VNS Therapy® System as Adjunctive Therapy Versus a No Stimulation Control in Subjects With Treatment-Resistant Depression (RECOVER)

Ziad Nahas
znahas@umn.edu
All
18 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT03887715
STUDY00009412
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Inclusion Criteria:
The patient must be in a major depressive disorder (MDD) episode for ≥ two years or have had at least four episodes of MDD, including the current episode. The patient's depressive illness meets a minimum criterion of four prior failed treatments of adequate dose and duration as measured by a tool designed for this purpose. The patient is experiencing a major depressive episode (MDE) as measured by a guideline recommended depression scale assessment tool on two visits, within a 45-day span prior to implantation of the VNS device. Patients must maintain a stable medication regimen for at least four weeks before device implantation.
Exclusion Criteria:
Current or lifetime history of psychotic features in any MDE; Current or lifetime history of schizophrenia or schizoaffective disorder; Current or lifetime history of any other psychotic disorder; Current or lifetime history of rapid cycling bipolar disorder; Current secondary diagnosis of delirium, dementia, amnesia, or other cognitive disorder; Current suicidal intent; or Treatment with another investigational device or investigational drugs.
Device: Vagus Nerve Stimulation (VNS)
Treatment Resistant Depression
VNS, Depression, TRD
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University of Minnesota — Minneapolis, Minnesota Maxwell Thorpe - (thorp131@umn.edu)

Phase 1/2 Study of MRTX849 in Patients With Cancer Having a KRAS G12C Mutation KRYSTAL-1

This study will evaluate the clinical activity/efficacy of MRTX849 in cohorts of patients having selected solid tumor malignancies with KRAS G12C mutation.

Manish Patel
patel069@umn.edu
All
18 Years and over
Phase 1/Phase 2
This study is NOT accepting healthy volunteers
NCT03785249
STUDY00009695
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Inclusion Criteria:

• Histologically confirmed diagnosis of a solid tumor malignancy with KRAS G12C mutation
• Unresectable or metastatic disease
• Standard treatment is not available or patient declines
• Adequate organ function
Exclusion Criteria:

• History of intestinal disease or major gastric surgery or inability to swallow oral medications
• Other active cancer
Drug: MRTX849, Drug: Pembrolizumab, Drug: Cetuximab, Drug: Afatinib
Advanced Cancer, Metastatic Cancer, Malignant Neoplastic Disease
Adagrasib, KRAS, NSCLC, Colorectal Cancer, Colon Cancer, Metastatic Cancer, Pancreatic Cancer, Phase I Clinic, STK11 mutation, KRAS G12C
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Metro-Minnesota Community Oncology Research Consortium — Saint Louis Park, Minnesota
Minnesota Oncology — Minneapolis, Minnesota
University of Minnesota — Minneapolis, Minnesota

Dose-escalation Study of Safety of PBCAR0191 in Patients With r/r NHL and r/r B-cell ALL

To evaluate the safety and tolerability of PBCAR0191 in subjects with r/r B-ALL and r/r NHL and find an appropriate dose to optimize safety and efficacy. To evaluate the clinical benefit of PBCAR0191 in subjects with r/r B-ALL and r/r NHL. To evaluate the clinical activity of PBCAR0191 in subjects with r/r B-ALL and r/r NHL.

Joseph Maakaron
maaka001@umn.edu
All
18 Years and over
Phase 1/Phase 2
This study is NOT accepting healthy volunteers
NCT03666000
STUDY00009953
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Key Inclusion Criteria* Criteria for B-ALL:
• Relapsed or refractory CD19+ B-cell acute lymphoblastic leukemia (B-ALL).
• Philadelphia chromosome positive (Ph+) disease can be eligible if they are intolerant to tyrosine kinase inhibitor (TKI) therapy or if they have relapsed/refractory disease. Criteria for NHL:
• r/r CD19+ B-cell NHL that is histologically confirmed by archived tumor biopsy tissue from last relapse and corresponding pathology report. The following types of lymphoma are included:
• Diffuse large B-cell lymphoma (DLBCL) including Richter's transformation
• Primary mediastinal B-cell lymphoma (PMBL)
• FL including Grade 3B or transformed FL
• High-grade B-cell lymphoma
• Small lymphocytic lymphoma (SLL)
• Mantle cell lymphoma (MCL)
• Received at least 2 prior chemotherapy-containing regimens. Subjects with SLL must have previously failed at least 2 lines of chemotherapy/immunotherapy that included ibrutinib and idelalisib plus rituximab.
• Measurable or detectable disease according to the Lugano Classification.
• Criteria for both B-ALL and NHL:
• Eastern Cooperative Oncology Group performance status score of 0 or 1.
• An estimated life expectancy of at least 12 weeks according to the investigator's judgment.
• Seronegative for human immunodeficiency virus antibody (i.e., intact immune function).
• Subject has adequate bone marrow, renal, hepatic, pulmonary, and cardiac function defined as: 1. Estimated glomerular filtration rate (eGFR) >50 mL/min/1.73 m2. 2. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels both ≤3 times of upper limit of normal, unless there is suspected disease in the liver. 3. Total bilirubin <2.0 mg/dL, except in subjects with Gilbert's syndrome. 4. Platelet count ≥30,000/µL (platelet transfusions acceptable). 5. Left ventricular ejection fraction >45% as assessed by echocardiogram (ECHO) or multiple gated acquisition scan performed within 1 month before starting lymphodepleting chemotherapy. ECHO results performed within 6 months before Screening and at least 28 days after the last cancer treatment may be acceptable if the subject has not received any treatment with cardiotoxicity risks. 6. No clinically significant evidence of pericardial effusion or pleural effusion. 7. Baseline oxygen saturation >92% on room air. Key Exclusion Criteria* Criteria for B-ALL:
• Burkitt cell (L3 ALL) or mixed-lineage acute leukemia.
• Active CNS leukemia. Criteria for NHL:
• Active hemolytic anemia.
• Active CNS lymphoma.
• Criteria for B-ALL and NHL:
• Previous malignancy, besides the malignancies of inclusion (B-ALL or NHL), that has a high risk of relapse in the next 2 years.
• Uncontrolled and serious fungal, bacterial, viral, protozoal, or other infection.
• Any form of primary immunodeficiency.
• Active hepatitis B or C.
• Uncontrolled cardiovascular disease.
• Hypertension crisis or hypertensive encephalopathy within 3 months.
• Concomitant genetic syndrome or any other known bone marrow failure syndrome.
• Active uncontrolled autoimmune disease requiring active immunosuppression (excluding subjects needing steroids for physiologic replacement).
• Received stem cell transplant within 90 days.
• Active GvHD symptoms.
• Received systemic biologic agent within 30 days or 5 half-lives.
• Received systemic immunostimulatory agent within 30 days or 5 half-lives.
• Radiotherapy within 4 weeks determined on a case-by-case basis.
• Presence of pleural/peritoneal/pericardial catheter.
• Received live vaccine within 4 weeks before Screening.
• Current use of any anticoagulant or antiplatelet therapy.
• Additional criteria apply
Genetic: PBCAR0191, Drug: Fludarabine, Drug: Cyclophosphamide
Non-Hodgkin Lymphoma, B-cell Acute Lymphoblastic Leukemia
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University of Minnesota — Minneapolis, Minnesota Fiona He, MD - (fionahe@umn.edu)

OCS™ Lung TOP Registry For Donor Lungs for Transplantation (TOP)

To collect additional real-world safety and effectiveness data for the OCS™ Lung System and to expand the long-term clinical evidence supporting the use of OCS™Lung System in lung transplantation.

Stephen Huddleston
huddl007@umn.edu
All
18 Years and over
This study is NOT accepting healthy volunteers
NCT03639025
STUDY00003837
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This is an all-comers registry that will enroll all:
• Consented patients who receive OCS™ preserved double lung transplants from either standard criteria donors or donors initially deemed unacceptable; and
• Consented patients who receive a single lung transplant from OCS™ preserved lung pairs from either standard criteria donors or donors initially deemed unacceptable; and
• All donor lungs that were perfused on OCS Lung System. Enrolled patients will fall into one of the following three possible analysis categories:
• TOP SCDL PAS Primary Analysis Population: will be comprised of the first 289 eligible/PAS consented recipients transplanted with SCDL primary analysis population eligible donor lungs preserved on the OCS™ Lung System.
• TOP DLIDU Primary Analysis Population: Will be comprised of the first 266 eligible/PAS consented recipients transplanted with DLIDU primary analysis population eligible donor lungs preserved on the OCS™ Lung System.
• All Other Enrolled Patients: will be comprised of all OCS Lung transplanted patients in the TOP Registry that do not meet any of the above analysis populations.
Device: OCS Lung System
Lung Transplantation
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University of Minnesota — Minneapolis, Minnesota Nick Lemke - (ntlemke@umn.edu)

Conditioning SCID Infants Diagnosed Early (CSIDE)

To determine the incidence of humoral immune reconstitution by 2 years post-transplant in 2 SCID cohorts (IL2RG/JAK3, RAG1/RAG2) undergoing alternative donor HCT by randomized assignment to a busulfan preparative regimen targeted at cumulative area-under-the-curve (cAUC) exposure of 25-35 mg*h/L vs 55-65 mg*h/ L.

Angela Smith
smith719@umn.edu
All
up to 2 Years old
Phase 2
This study is NOT accepting healthy volunteers
NCT03619551
STUDY00006513
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Inclusion Criteria:
1. Infants with SCID, either typical or leaky or Omenn syndrome. 1. Typical SCID is defined as either of the following
• Absence or very low number of T cells (CD3+ T cells <300/microliter AND no or very low T cell function (<10% of lower limit of normal) as measured by response to phytohemagglutinin OR
• Presence of maternally derived T cells 2. Leaky SCID is defined as the following • Absence of maternally derived T cells • AND either one or both of the following (i, ii): i) <50% of lower limit of normal T cell function as measured by response to PHA OR <30% of lower limit of normal T cell function as measured by response to CD3 ii) Absent or <10% of lower limit of normal proliferative responses to candida and tetanus toxoid antigens (must document post vaccination or exposure for this criterion to apply) • AND at least two of the following (i through iii): i) CD3 T cells < 1500/microliter ii) >80% of CD3+ or CD4+ T cells are CD45RO+ AND/OR >80% of CD3+ or CD4+ T cells are CD62L negative AND/OR >50% of CD3+ or CD4+ T cells express HLA-DR (at < 4 years of age) AND/OR are oligoclonal T iii) Low TRECs and/or the percentage of CD4+/45RA+/CD31+ or CD4+/45RA+/CD62L+ cells is below the lower level of normal. 3. Omenn syndrome • Generalized skin rash
• Maternal lymphocytes tested for and not detected.
• >80% of CD3+ or CD4+ T cells are CD45RO+ AND/OR >80% of CD3+ or CD4+ T cells are CD62L negative AND/OR >50% of CD3+ or CD4+ T cells express HLA-DR (<2 years of age)
• Absent or low (up to 30% lower limit of normal (LLN)) T cell proliferation to antigens (Candida, tetanus) to which the patient has been exposed IF: Proliferation to antigen was not performed, but at least 4 of the following 8 supportive criteria, at least one of which must be among those marked with an asterisk (*) below are present, the patient is eligible as Omenn Syndrome. 1. Hepatomegaly 2. Splenomegaly 3. Lymphadenopathy 4. Elevated IgE 5. Elevated absolute eosinophil count 6. *Oligoclonal T cells measured by CDR3 length or flow cytometry (upload report) 7. *Proliferation to PHA is reduced to < 50% of lower limit of normal (LLN) or SI < 30 8. *Low TRECs and/or percentage of CD4+/RA+ CD31+ or CD4+/RA+ CD62L+ cells below the lower level of normal 2. Documented mutation in one of the following SCID-related genes a. Cytokine receptor defects (IL2RG, JAK3) b. T cell receptor rearrangement defects (RAG1, RAG2) 3. No available genotypically matched related donor (sibling) 4. Availability of a suitable donor and graft source 1. Haploidentical related mobilized peripheral blood cells 2. 9/10 or 10/10 allele matched (HLA-A, -B, -C, -DRB1, -DQB1) volunteer unrelated donor mobilized peripheral blood cells 5. Age 0 to 2 years at enrollment Note: to ensure appropriate hepatic metabolism, age at time of busulfan start: For IL2RG/JAK3: 8 weeks For RAG1/RAG2: 12 weeks 6. Adequate organ function defined as: 1. Cardiac: Left ventricular ejection fraction (LVEF) at rest ≥ 40% or, shortening fraction (SF) ≥ 26% by echocardiogram. 2. Hepatic: Total bilirubin < 3.0 x the upper limit of normal (ULN) for age (patients who have been diagnosed with Gilbert's Disease are allowed to exceed this limit) and AST and ALT < 5.0 x ULN for age. 3. Renal: GFR estimated by the updated Schwartz formula ≥ 90 mL/min/1.73 m2. If the estimated GFR is < 90 mL/min/1.73 m2, then renal function must be measured by 24-hour creatinine clearance or nuclear GFR, and must be > 50 mL/min/1.73 m2. 4. Pulmonary No need for supplemental oxygen and O2 saturation > 92% on room air at sea level (with lower levels allowed at higher elevations per established center standard of care).
Exclusion Criteria:
1. Presence of any serious life-threatening or opportunistic infection at time of enrollment and prior to the initiation of the preparative regimen. Serious infections as defined below that occur after enrollment must be reported immediately to the Study Coordinating Center, and enrollment will be put on hold until the infection resolves. Ideally enrolled subjects will not have had any infection. If patients have experienced infections, these must have resolved by the following definitions: a. Bacterial i. Positive culture from a sterile site (e.g. blood, CSF, etc.): Repeat culture(s) from same site must be negative and patient has completed appropriate course of antibacterial therapy (typically at least 10 days). ii. Tissue-based clinical infection (e.g. cellulitis): Complete resolution of clinical signs (e.g. erythema, tenderness, etc.) and patient has completed appropriate course of antibacterial therapy (typically at least 10 days). iii. Pneumonia, organism not identified by bronchoalveolar lavage: Complete resolution of clinical signs (e.g. tachypnea, oxygen requirement, etc.) and patient has completed appropriate course of antibacterial therapy (typically at least 10 days). If possible, radiographic resolution should also be demonstrated. b. Fungal i. Positive culture from a sterile site (e.g. blood, CSF, etc.): Repeat culture(s) from same site is negative and patient has completed appropriate course of antifungal therapy (typically at least 14 days). The patient may be continued on antifungal prophylaxis following completion of the treatment course. c. Pneumocystis i. Complete resolution of clinical signs (e.g. tachypnea, oxygen requirement, etc.) and patient has completed appropriate course of therapy (typically at least 21 days). If possible, radiographic resolution should also be demonstrated. The patient may be continued on prophylaxis following completion of the treatment course. d. Viral i. Viral PCRs from previously documented sites (blood, nasopharynx, CSF) must be re-tested and are negative. ii. If re-sampling a site is not clinically feasible (i.e. BAL fluid): Complete resolution of clinical signs (e.g. tachypnea, oxygen requirement, etc.). If possible, radiographic resolution should also be demonstrated. 2. Patients with HIV or HTLV I/II infection will be excluded.
Drug: Busulfan, Device: Cell processing for TCRαβ+/CD19+ depletion
SCID
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University of Minnesota — Minneapolis, Minnesota Anna Babcock - (kist0027@umn.edu) Andrea Middendorf - (midde019@umn.edu)

SpHincterotomy for Acute Recurrent Pancreatitis (SHARP)

This is a sham-controlled, single blinded with a blinded outcome assessment, multi-center, randomized clinical trial of endoscopic retrograde cholangiopancreatography (ERCP) with minor papilla endoscopic sphincterotomy (miES) for the treatment of recurrent acute pancreatitis (RAP) with pancreas divisum. ERCP with miES is often offered in clinical practice to patients with RAP, pancreas divisum, and no other clear risk factors for their acute pancreatitis episodes. We hypothesize that obstruction at the level of the minor papilla is one cause of RAP in pancreas divisum; miES will relieve the obstruction, thereby reducing the risk of a recurrent attack(s) of acute pancreatitis.

Martin Freeman
freem020@umn.edu
All
18 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT03609944
STUDY00004817
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Inclusion Criteria:
1. Patient must consent to be in the study and must have signed and dated an approved consent form. 2. >18 years 3. Two or more episodes of acute pancreatitis, with each episode meeting two of the following three criteria:
• abdominal pain consistent with acute pancreatitis (acute onset of a persistent, severe, epigastric pain often radiating to the back)
• serum lipase activity (or amylase activity) at least three times greater than the upper limit of normal
• characteristic findings of acute pancreatitis on CECT, MRI or transabdominal ultrasonography 4. At least one episode of acute pancreatitis within 24 months of enrollment 5. Pancreas divisum confirmed by prior MRCP that is reviewed by an abdominal radiologist at the recruiting site. 6. By physician assessment, there is no certain explanation for recurrent acute pancreatitis. 7. Subjects must be able to fully understand and participate in all aspects of the study, including completion of questionnaires and telephone interviews, in the opinion of the clinical investigator
Exclusion Criteria:
1. Prior minor papilla therapy (endoscopic or surgical) 2. Calcific chronic pancreatitis, defined as parenchymal or ductal calcifications identified on computed tomography or magnetic resonance imaging scan that is reviewed by an expert radiologist at the recruiting site. 3. Main pancreatic duct stricture* 4. Presence of a structural etiology for acute pancreatitis, such as anomalous pancreatobiliary union, periampullary mass, or pancreatic mass lesion on imaging* 5. Presence of a local complication from acute pancreatitis which requires pancreatogram 6. Regular use of opioid medication for abdominal pain for the past three months 7. Medication as the etiology for acute pancreatitis by physician assessment 8. TWEAK score ≥ 4
Procedure: ERCP with miES, Procedure: EUS
Pancreatitis, Pancreas Divisum, Pancreatitis, Acute, Pancreatitis Idiopathic, Pancreas Inflamed
ERCP, Endoscopic retrograde cholangiopancreatography, pancreatitis
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University of Minnesota — Minneapolis, Minnesota Ghislaine Feussom - (feuss001@umn.edu)

Study of the Safety and Efficacy of OMS721 in Patients With Immunoglobulin A (IgA) Nephropathy

This is a Phase 3, double-blind, randomized, placebo-controlled, study in patients aged 18 years and above with a biopsy-confirmed diagnosis of IgAN and with 24-hour UPE that is > 1 g/day at baseline. During the study, all patients will continue optimized renin-angiotensin system (RAS) blockade. The study consists of five periods: Screening, Run-In, Initial Treatment (Weeks 1-12), Response Evaluation (Weeks 13-24), and Follow-Up (Weeks 25 to end-of-study). The study duration for each patient is expected to last up to 160 weeks.

Patrick Nachman
pnachman@umn.edu
All
18 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT03608033
STUDY00002971
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Inclusion Criteria:

• Age 18 years or older at the onset of Screening
• Biopsy confirmed diagnosis of IgAN within 8 years prior to Screening
• Proteinuria of > 1 g/day within 6 months prior to Screening or uPCR > 0.75 by spot urine at Screening
• Mean of two proteinuria measurements > 1 g/day at baseline
• Estimated glomerular filtration rate of ≥ 30 mL/min/1.73 m2 at Screening and baseline
Exclusion Criteria:

• Treatment with immunosuppressants (e.g., azathioprine or cyclophosphamide), or cytotoxic drugs, for IgA within 8 weeks prior to Screening. Treatment with immunosuppressants or cytotoxic drugs for IgAN is not allowed during the Run-In Period. Treatment with immunosuppressants are allowed if such treatment is for indications other than IgAN.
• Treatment with eculizumab within 8 weeks prior to Screening. Treatment with eculizumab is not allowed during the Run-In Period.
• Treatment with systemic corticosteroids within 8 weeks prior to Screening. Treatment with systemic corticosteroids is not allowed during the Run-In Period.
• Uncontrolled BP, a systolic BP of > 150 mmHg and a diastolic BP of > 100 mmHg at rest despite the combination of two or more anti-hypertensives including ACEIs, ARBs, or direct renin inhibitors at Screening and baseline
• Female patients who are pregnant, breast feeding, or planning to become pregnant up through 12 weeks after the last dose of study drug, including possible retreatments
• Clinical or biological evidence of Type 1 diabetes mellitus (DM), or poorly controlled DM with hemoglobin A1c > 7.5 or with evidence of diabetic nephropathy on biopsy, systemic lupus erythematosus, IgA vasculitis (Henoch-Schonlein purpura), secondary IgAN, or other renal disease during Screening and Run-In
• History of renal transplantation
• Have a known hypersensitivity to any constituent of the investigational product
• Rapidly progressive glomerulonephritis
• Significant abnormalities in clinical laboratory values
• History of human immunodeficiency virus (HIV), evidence of immune suppression, active HCV infection (patients with positive anti-HCV antibody but a non-detected HCV RNA PCR can enroll), HBV infection (patients with positive HBsAg are excluded. For patients with isolated positive anti-HBc antibody, HBV DNA test by PCR must be non-detectable to enroll).
• Diagnosis of a malignancy except for adequately treated and cured basal or squamous cell skin cancer, curatively treated in situ disease, or other cancer from which the patient has been disease-free for ≥ 5 years
• Have received any other investigational drug or device or experimental procedures within 30 days of the Screening Visit (SV)
Biological: OMS721, Other: Vehicle (D5W or saline)
IgA Nephropathy
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University of Minnesota — Minneapolis, Minnesota Laura Haas - (lhaas@omeros.com)

SLIP II Registry: Spinal Laminectomy Versus Instrumented Pedicle Screw Fusion (SLIP II)

David Polly
pollydw@umn.edu
All
18 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT03570801
STUDY00003517
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Inclusion Criteria:

• Symptomatic lumbar spinal stenosis: defined as radicular and/or back pain either induced or aggravated by activity and relieved by rest.
• Single-level grade I degenerative spondylolisthesis (3-14mm)
Exclusion Criteria:

• Serious medical illness (ASA Class IV or higher)
• Spondylolysis
• Multilevel spondylolisthesis or high grade spondylolisthesis (grade II or greater than 14mm)
Other: Expert Panel Review
Lumbar Spondylolisthesis, Grade 1 Spondylolisthesis, Lumbar Spinal Stenosis, Degenerative Spondylolisthesis
Lumbar Spondylolisthesis, Grade 1 Spondylolisthesis, Lumbar Spinal Stenosis, Degenerative Spondylolisthesis
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University of Minnesota — Minneapolis, Minnesota David Polly, MD Allison Wolf - (wolfx494@umn.edu)

Long-Term Follow-up Protocol for Subjects Treated With Gene-Modified T Cells

This study is designed for the following purpose: - To assess the risk of delayed adverse events (AEs) following exposure to genemodified(GM) T cells - To monitor for long-term persistence of GM T cells, including analysis of vector integration sites, as appropriate. - To monitor for generation of replication competent retroviruses (RCR) - To assess long-term efficacy following treatment with GM T cells - Describe growth, developmental outcome, and sexual maturity status for subjects who were aged < 18 years at time of GM T cell treatment - To assess long term health-related quality of life following treatment with GM T cells

Veronika Bachanova, MD
bach0173@umn.edu
All
Not specified
Phase 2/Phase 3
This study is NOT accepting healthy volunteers
NCT03435796
STUDY00006610
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Inclusion Criteria:
Subjects who meet the following criteria will be eligible to participate in the Long-Term Follow-Up study: 1. All adult and pediatric subjects who received at least one GM T cells infusion in a previous Celgene sponsored or Celgene alliance partner sponsored study, and have discontinued, or completed the post-treatment follow-up period in the parent treatment protocol, as applicable. 2. Subject (and, parental/legal representative, when applicable) must understand and voluntarily sign an Informed Consent Form/Informed Assent Form prior to any study-related assessments/procedures being conducted. 3. Subject is willing and able to adhere to the study visit schedule and other protocol requirements.
Exclusion Criteria:
Not Applicable
Genetic: Gene-modified (GM) T cell therapy
Neoplasms
Long-term follow up, Gene-Modified T Cells, CAR T Cell
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University of Minnesota — Minneapolis, Minnesota

Effect of Tumor Treating Fields (TTFields, 150 kHz) as Front-Line Treatment of Locally-advanced Pancreatic Adenocarcinoma Concomitant With Gemcitabine and Nab-paclitaxel (PANOVA-3)

Adult patients with locally advanced, unresectable pancreatic carcinomas will be screened at baseline, and randomized 1:1 to treatment in either of two arms: standard-of-care palliative chemotherapy using gemcitabine + nab-paclitaxel (given on days 1, 8, and 15 of each 28-day cycle), or the same chemotherapeutic regimen with the addition of alternating electric tumor-treating fields (TTFields) applied to the patients abdominal cavity using pads attached to a source pack. The TTFields are applied 24 hours per day/7 days per week. Follow-up CT scans will be performed every 8 weeks, as is standard of care, with post-progression follow-up visits and survival follow-up visits every four weeks.

Emil Lou
emil-lou@umn.edu
All
18 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT03377491
STUDY00004177
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Inclusion Criteria:
1. 18 years of age and older 2. Life expectancy of ≥ 3 months 3. Histological/cytological diagnosis of de novo adenocarcinoma of the pancreas 4. Unresectable, locally advanced stage disease according to the following criteria:
• Head/uncinate process: 1. Solid tumor contact with SMA>180° 2. Solid tumor contact with the CA>180° 3. Solid tumor contact with the first jejunal SMA branch 4. Unreconstructible SMV/PV due to tumor involvement or occlusion (can be d/t tumor or bland thrombus) 5. Contact with most proximal draining jejunal branch into SMV
• Body and tail 1. Solid tumor contact of >180° with the SMA or CA 2. Solid tumor contact with the CA and aortic involvement 3. Unreconstructible SMV/PV due to tumor involvement or occlusion (can be d/t tumor or bland thrombus)
• No distant metastasis, including non-regional lymph node metastasis
• No borderline resectable (per Al-Hawary MM, et al., Radiology 201414) 5. ECOG score 0-2 6. Amenable and assigned by the investigator to receive therapy with gemcitabine and nab-paclitaxel 7. Able to operate the NovoTTF-100L(P) System independently or with the help of a caregiver 8. Signed informed consent form for the study protocol
Exclusion Criteria:
1. Prior palliative treatment (e.g. surgery, radiation) to the tumor 2. Cancer requiring anti-tumor treatment within the 5 years before inclusion, excluding treated stage I prostate cancer, in situ cervical or uterus cancer, in situ breast cancer and non-melanomatous skin cancer. 3. Serious co-morbidities: 1. Clinically significant (as determined by the investigator) hematological, hepatic and renal dysfunction, defined as: Neutrophil count < 1.5 x 10^9/L and platelet count < 100 x 10^9/L; bilirubin > 1.5 x Upper Limit of Normal (ULN); AST and/or ALT > 2.5 x ULN; and serum creatinine > 1.5 x ULN. 2. History of significant cardiovascular disease unless the disease is well controlled. Significant cardiac disease includes second/third degree heart block; significant ischemic heart disease; poorly controlled hypertension; congestive heart failure of the New York Heart Association (NYHA) Class II or worse (slight limitation of physical activity; comfortable at rest, but ordinary activity results in fatigue, palpitation or dyspnea). 3. History of arrhythmia that is symptomatic or requires treatment. Patients with atrial fibrillation or flutter controlled by medication are not excluded from participation in the trial. 4. History of cerebrovascular accident (CVA) within 6 months prior to randomization or that is not stable. 5. Active infection or serious underlying medical condition that would impair the ability of the patient to receive protocol therapy. 6. History of any psychiatric condition that might impair patient's ability to understand or comply with the requirements of the study or to provide consent. 4. Concurrent anti-tumor therapy beyond gemcitabine and nab-paclitaxel 5. Implantable electronic medical devices in the torso, such as pacemakers 6. Known severe hypersensitivities to medical adhesives or hydrogel, or to one of the chemotherapies used in this trial. 7. Pregnancy or breast-feeding (female patients with reproductive potential and their partners must accept to use effective contraception throughout the entire study period and for 3 months after the end of treatment). All patients who are capable of becoming pregnant must take a pregnancy test which is negative within 72 hours before beginning treatment. The definition of effective contraception is left up to the decision of the investigator. 8. Unable to follow the protocol for medical, psychological, familial, geographic or other reasons. 9. Admitted to an institution by administrative or court order.
Device: NovoTTF-100L(P), Drug: Gemcitabine, Drug: nab paclitaxel
Pancreas Adenocarcinoma
Locally Advanced Pancreatic Adenocarcinoma, TTFields, Tumor Treating Fields, Gemcitabine, nab-Paclitaxel, Minimal toxicity, TTF, Novocure
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University of Minnesota — Minneapolis, Minnesota Emil Lou, MD - (emil-lou@umn.edu)

Neihulizumab (AbGn-168H) in Patients With Steroid-refractory Acute Graft-versus-host Disease or Treatment-refractory Acute Graft-versus-host Disease

The purpose of this study is to understand the pharmacokinetic (PK) profile of the study drug in patients like you. PK samples tell us what your body does to process the drugs and how your body gets them out of your system. This study will also look at safety of the study drug, and signs of efficacy (clinically or by laboratory measurement) of the study drug in patients like you.

Shernan Holtan
sgholtan@umn.edu
All
12 Years and over
Phase 1
This study is NOT accepting healthy volunteers
NCT03327857
STUDY00003120
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Inclusion Criteria (must meet all of the following criteria): 1. Patients must have clinical aGVHD and pathologic findings consistent with the diagnosis by biopsy of at least 1 involved site, and 1. progressed after 3 days of treatment with methylprednisolone (MP) 2 mg/kg/day equivalent, or 2. did not improve after 7 days of treatment with MP 2 mg/kg/day equivalent, or 3. progressed to involve a new organ after treatment with MP 1 mg/kg/day equivalent for skin and upper gastrointestinal (GI) GVHD, or 4. recurred during or after a steroid taper 2. For single dose phase: Patients must have erythematous manifestations of cutaneous aGVHD. Characteristics of the rash must indicate active inflammation (red coloration) as distinct from resolving inflammation (brown coloration). 3. For single dose phase: Providers and patients must be willing to defer new systemic or cutaneous topical treatment of aGVHD for at least 36 hr after administration of Neihulizumab. 4. Patient must give informed consent and sign an approved consent form prior to any study procedures. 5. Females of childbearing potential must have a negative pregnancy test result before enrollment. Males and females of childbearing potential must agree to use a highly effective method of birth control during the study for at least 30 days after enrollment in the study. Exclusion Criteria (may not meet any of the following criteria): 1. For single dose phase: Prior administration of anti-lymphocyte globulin or anti- thymocyte globulin for treatment of aGVHD. 2. For multiple dose phase: Has received any systemic treatment in addition to corticosteroids for aGVHD. 3. Stage 4 lower GI GVHD, defined by the presence of ileus, severe abdominal pain, or overt GI bleeding. 4. Uncontrolled infections not responding to antimicrobial therapy or requiring intensive critical care or vasopressors. 5. Evidence of end-organ cytomegalovirus (CMV) or adenovirus infection. 6. Known to have adenovirus, or Epstein Barr virus (EBV) viremia from screening according to institutional standard practice. Patients receiving appropriate antiviral treatment for CMV, HHV6 or hepatitis viremia are eligible on a case-by-case basis. 7. HIV infection or a known HIV-related malignancy. 8. Tuberculosis, history of tuberculosis or a known positive Quantiferon test for tuberculosis. 9. Unplanned donor lymphocyte infusion (DLI) for residual or relapsed malignancy or mixed chimerism. DLI as part of the planned HCT protocol is allowed. 10. Known relapsed or progressive malignancy after transplant, posttransplant lymphoproliferative disease or any secondary malignancy diagnosed after HCT. 11. Absolute neutrophil count (ANC) <1000/mm3. 12. Total serum bilirubin concentration >3.0 mg/dL UNLESS attributed to GVHD. 13. Creatinine clearance < 30 mL/min calculated by Cockcroft-Gault equation. 14. Sodium (Na) concentration < 130 mmol/L. 15. Karnofsky Performance Status (KPS) or Lansky Performance Status < 20%. 16. Intensive care unit (ICU) care, life expectancy of less than 28 days, ongoing or unresolved hepatic sinusoidal obstruction syndrome, unstable hemodynamics, or evidence of current or previous clinically significant disease, medical condition or finding (including vital signs and ECG) that in the opinion of the Investigator, would compromise the safety of the patient or the quality of the data. 17. History of allergy or hypersensitivity to any systemically administered antibody agent or its excipients. 18. Pregnancy or nursing. 19. Less than 12 years of age.
Biological: Neihulizumab (AbGn-168H)
Steroid-refractory Acute Graft-versus-Host Disease, Treatment-refractory Acute Graft-versus-Host Disease
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University of Minnesota — Minneapolis, Minnesota Janine Delage - (jdelage@umn.edu)

Study of Crenolanib vs Midostaurin Following Induction Chemotherapy and Consolidation Therapy in Newly Diagnosed FLT3 Mutated AML

This study is meant to compare the efficacy of crenolanib with midostaurin administered following induction chemotherapy and consolidation therapy on event-free survival (EFS) in newly diagnosed acute myeloid leukemia subjects with FLT3 mutation.

Mark Juckett
juck0001@umn.edu
All
18 Years to 60 Years old
Phase 3
This study is NOT accepting healthy volunteers
NCT03258931
STUDY00002581
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Inclusion Criteria:

• Confirmed diagnosis of de novo AML according to World Health Organization (WHO) 2016 classification
• Presence of FLT3-ITD and/or D835 mutation(s) in bone marrow or peripheral blood
• Age ≥ 18 years and ≤ 60 years
• Adequate hepatic function within 48 hours prior to induction chemotherapy
• Adequate renal functions within 48 hours prior to induction chemotherapy
• ECOG performance status within 48 hours prior to induction chemotherapy ≤ 3
• Eligible for intensive cytarabine/daunorubicin (7+3) chemotherapy specified
Exclusion Criteria:

• Acute promyelocytic leukemia (APL)
• Known clinically active central nervous system (CNS) leukemia
• Severe liver disease
• Active infections
• Known, active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV)
• Known infection with human immunodeficiency virus (HIV)
• Prior systemic anti-cancer treatment (e.g. chemotherapy, tyrosine kinase inhibitors, immunotherapy, or investigational agents)(except for hydroxyurea and/or leukapheresis)
Drug: Crenolanib, Drug: Midostaurin, Drug: Cytarabine, Drug: Duanorubicin
Newly Diagnosed FLT3 Mutated AML
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University of Minnesota — Minneapolis, Minnesota Erica Warlick, MD - (ewarlick@umn.edu)

Diagnostic and Therapeutic Applications in Microarrays in Organ Transplantation

All
18 Years and over
This study is NOT accepting healthy volunteers
NCT01299168
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Inclusion Criteria:

• All kidney transplant recipients ≥18yrs of age undergoing a kidney biopsy for clinical indications, as determined by their physician or surgeon, will be eligible to enrol in the study.
Exclusion Criteria:

• Patients will be excluded from the study if they decline participation or are unable to give informed consent.
Validation Study of Molecular Diagnostic System, Development of Reporting System for Molecular Diagnosis, Incorporate Molecular Diagnosis Into Diagnostic Standards
global gene expression, molecular diagnostic classifiers
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University of Minnesota — Minneapolis, Minnesota

A Study of Androgen Annihilation in High-Risk Biochemically Relapsed Prostate Cancer

Emmanuel Antonarakis
anton401@umn.edu
Male
18 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT03009981
STUDY00003709
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Inclusion Criteria:

• Histologically confirmed prostate adenocarcinoma
• Prior radical prostatectomy
• Biochemically recurrent prostate cancer with PSA doubling time ≤ 9 months at the time of study entry. Calculation of PSA doubling time should include the use of all available PSA values obtained within past 6-12 months prior to randomization, with a minimum of 3 values separated by at least 2 weeks apart. PSA values obtained prior to therapeutic interventions (e.g. salvage radiation) will be excluded. PSA doubling time to be estimated using Memorial Sloan Kettering Cancer Center online calculator (https://www.mskcc.org/nomograms/prostate/psa-doubling-time)
• Prior adjuvant or salvage radiation or not a candidate for radiation based upon clinical assessment of disease characteristics and patient co-morbidities.
• Screening PSA > 0.5 ng/mL
• No definitive evidence of metastases on screening CT or MRI of abdomen/pelvis and radionuclide whole body bone scan per the judgment of the investigator. Abdominal and/or pelvic lymph nodes measuring 2 cm or less in short axis diameter are allowed. Lesions identified on other imaging modalities (e.g. PSMA or choline PET) that are not visualized on CT and/or MRI or radionuclide bone scan are allowed. Equivocal lesions on bone scan should be followed up with additional imaging as clinically indicated.
• Screening serum testosterone > 150 ng/dL
• Eastern Cooperative Oncology Group (ECOG) Performance Status grade 0 or 1
• Age ≥ 18 years
• Medications known to lower the seizure threshold must be discontinued or substituted at least 4 weeks prior to cycle 1 day 1
• Agrees to use a condom (even men with vasectomies) and another effective method of birth control if he is having sex with a woman of childbearing potential or agrees to use a condom if he is having sex with a woman who is pregnant while on study drug and for 3 months following the last dose of study drug. Must also agree not to donate sperm during the study and for 3 months after receiving the last dose of study drug.
• Adequate organ function as defined by the following laboratory values at screening:
• Serum aspartate transaminase (AST; serum glutamic oxaloacetic transaminase [SGOT]) and serum alanine transaminase (ALT; serum glutamic pyruvic transaminase [SGPT]) < 2.5 x upper limit of normal (ULN)
• Total serum bilirubin ≤1.5 x ULN. In subjects with Gilbert's syndrome, if total bilirubin is >1.5 × ULN, measure direct and indirect bilirubin and if direct bilirubin is ≤1.5 × ULN, subject may be eligible)
• Serum potassium ≥ 3.5 mmol/L. Supplementation and re-screening is allowed.
• Estimated creatinine clearance > 45 ml/min using Cockroft-Gault equation
• Platelets ≥ 100,000/microliter independent of transfusion and/or growth factors within 3 months prior to randomization
• Hemoglobin ≥ 9.0 g/dL independent of transfusion and/or growth factors within 3 months prior to randomization
• Serum albumin ≥ 3.0 g/dL
Exclusion Criteria:

• Prior androgen deprivation therapy and/or first generation anti-androgen (e.g. bicalutamide, nilutamide, flutamide) for biochemically recurrent prostate cancer. Prior ADT and/or first generation anti-androgen in the (neo)adjuvant and/or salvage setting before, during, and/or following radiation or surgery is allowed provided last effective dose of ADT and/or first-generation anti-androgen is > 9 months prior to date of randomization and total duration of prior therapy is ≤ 36 months.
• Prior treatment with CYP17 inhibitor (e.g. ketoconazole, abiraterone acetate, galeterone) or second generation androgen receptor antagonist including apalutamide or enzalutamide
• Prior chemotherapy for prostate cancer except if administered in neoadjuvant or adjuvant setting
• Use of 5-alpha reductase inhibitor within 42 days prior to cycle 1 day 1
• Use of investigational agent within 28 days prior to randomization
• Use of other prohibited medications within 7 days prior to cycle 1 day 1 on study (Arms B and C only)
• Prior bilateral orchiectomy
• Seizure or known condition that may pre-dispose to seizure (e.g. prior stroke within 1year to randomization, brain arteriovenous malformation, Schwannoma, meningioma, or other benign CNS or meningeal disease which may require treatment with surgery or radiation therapy)
• Uncontrolled hypertension
• Gastrointestinal disorder affecting absorption or the ability to swallow tablets
• Baseline severe hepatic impairment (Child-Pugh Class B & C)
• Intercurrent illness that is not controlled such as active infection, psychiatric illness/social situations that would limit compliance with study requirements
• Any chronic medical condition requiring a higher dose of corticosteroid than equivalent of 5 mg prednisone/prednisolone once daily
Drug: Apalutamide, Drug: LHRH Analogue, Drug: Abiraterone Acetate, Drug: Prednisone
Prostate Cancer
PSA, Degarelix, Apalutamide, Abiraterone Acetate, Radical Prostatectomy, Bicalutamide, Leuprolide, Lupron
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Metro Minnesota Community Oncology Research Consortium — Saint Louis Park, Minnesota Daniel Anderson, MD
University of Minnesota — Minneapolis, Minnesota Arpit Rao, MD

A Study of Maribavir Compared to Valganciclovir to Treat Cytomegalovirus Infections in People Who Have Received Stem Cell Transplants

Drug study - Maribavir in HSCT patients with CMV infections

Jo-Anne Young, MD
vanbu004@umn.edu
All
16 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT02927067
1703M11501
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Inclusion Criteria:

• Be able to provide written, personally signed, and dated informed consent to participate in the study before completing any study-related procedures. As applicable, a parent/both parents or legally authorized representative (LAR) must provide signature of informed consent and there must be documentation of assent by the participants before completing any study-related procedures. During the COVID-19 public health emergency, informed consent from a potential or current trial participant may, if permitted by local laws and regulations, be obtained via electronic informed consent (eIC) capabilities or an electronic face-to-face consent interview when these individuals are unable to travel to the site (FDA COVID-19 Guidance, 27 January 2021, Q11).
• Be greater than or equal to (>=) 16 years of age at the time of consent.
• Be a recipient of hematopoietic stem cell transplant.
• Have a documented asymptomatic CMV infection, with a screening value of CMV DNA >=1365 International Units per millilitre (IU/mL) to less than or equal to (<=) 273000 IU/mL in whole blood or >=455 IU/mL to <=91000 IU/mL in plasma in 2 consecutive assessments, separated by at least 1 day, as determined by local or central specialty laboratory quantitative polymerase chain reaction (qPCR) or comparable quantitative CMV DNA results. Both samples should be taken within 14 days prior to randomization with second sample obtained within 5 days prior to randomization. Same laboratory and same sample type (whole blood or plasma) should be used for these assessments. Asymptomatic CMV infection is defined as an infection that does not present with tissue invasive CMV disease, as assessed by the investigator. Participants with CMV DNA less than (<) 910 and >=455 IU/mL in plasma or <2730 and >=1365 IU/mL in whole blood will also need to meet at least 1 of the following criteria for high-risk CMV infection to be eligible: 1. Human leukocyte antigen (HLA)-related (sibling) donor with at least 1 mismatch at 1 of the following 3 HLA-gene loci: HLA-A, -B or -DR, 2. Haploidentical donor 3. Unrelated donor with at least 1 mismatch at 1 of the following 4 HLA -gene loci: HLA-A, -B, -C and -DRB1, 4. Use of umbilical cord blood as stem cell source, 5. Use of ex vivo T-cell-depleted grafts, 6. Grade 2 or greater graft-versus-host-disease (GVHD), requiring the use of systemic corticosteroids (defined as the use of >=1 milligram per kilogram per day (mg/kg/day) of prednisone or equivalent dose of another corticosteroid).
• Have the current CMV infection as the first episode of CMV viremia after HSCT, either primary or reactivation, which in the investigator's opinion requires treatment.
• Per investigator's judgment, be eligible for treatment with valganciclovir.
• Have all of the following results as part of screening laboratory assessments (results from either the central laboratory or a local laboratory can be used for qualification): 1. Absolute neutrophil count to >=1000 per cubic millimeter (/mm^3) [1.0*10^9/L]. 2. Platelet count >=25,000/mm^3 [25*10^9/L]. 3. Hemoglobin >=8 grams per deciliter (g/dL). 4. Estimated creatinine clearance >=30 milliliters per minute (mL/min).
• Have a negative serum beta human chorionic gonadotropin (beta-HCG) pregnancy test at screening, if a female of child bearing potential. Urine pregnancy tests may be done per institutional requirements; however they are not sufficient for eligibility determination. Sexually active females of child bearing potential must agree to comply with any applicable contraceptive requirements of the protocol. If male, must agree to use an acceptable method of birth control, as defined in the protocol, during the study treatment administration period and for 90 days afterward the last dose of study treatment.
• Be able to swallow tablets.
• Have life expectancy of >=8 weeks.
• Weigh >=40 kilograms (kg).
• Be willing and have an understanding and ability to fully comply with study procedures and restrictions defined in the protocol.
Exclusion Criteria:

• Have CMV tissue invasive disease as assessed by the investigator at the time of screening and randomization at Visit 2/Day 0.
• Have a CMV infection that is known to be genotypically resistant to ganciclovir, valganciclovir, foscarnet, or cidofovir based on documented evidence.
• Be presenting with recurrent CMV infection (defined as a new detection of CMV infection in a participants who had at least one previously documented episode of CMV infection post-transplant, and who has had at least 2 weeks of undetectable CMV DNA between the episodes during active surveillance, based on same local laboratory and same sample type). The Participants must also have been off any anti-CMV treatment between the current and prior infection. Otherwise, the current infection may be considered continuation of the prior infection.
• Require ganciclovir, valganciclovir, foscarnet, or cidofovir administration for conditions other than CMV when study treatment is initiated (example: herpes simplex virus [HSV] co-infection requiring use of any of these agents after the randomization) or would need a co-administration with maribavir for CMV infection.
• Be receiving leflunomide, letermovir, or artesunate when study treatment is initiated. Note: Participants who may be receiving leflunomide must discontinue the use at least 14 days prior to randomization at Visit 2/Day 0 and the first dose of study treatment. Participants receiving letermovir must discontinue use 3 days prior to first dose of study treatment. Participants receiving artesunate must discontinue the use prior to the first dose of study treatment.
• Be on treatment with anti-CMV agents (ganciclovir, valganciclovir, foscarnet or letermovir) for the current CMV infection for longer than 72 hours.
• Have known hypersensitivity to the active substance or to an excipient of the study treatments.
• Have severe vomiting, diarrhea, or other severe gastrointestinal illness within 24 hours prior to the first dose of study treatment that would preclude administration of oral medication.
• Require mechanical ventilation or vasopressors for hemodynamic support at the time of randomization.
• Be female and pregnant or nursing.
• Have previously completed, discontinued, or have been withdrawn from this study.
• Have received any investigational agent with known anti-CMV activity within 30 days before initiation of study treatment or CMV vaccine at any time.
• Have received any unapproved agent or device within 30 days before initiation of study treatment.
• Have any clinically significant medical or surgical condition that, in the investigator's opinion, could interfere with interpretation of study results, contraindicate the administration of the assigned study treatment, or compromise the safety or well-being of the participant.
• Have previously received maribavir.
• Have serum aspartate aminotransferase (AST) greater than (>) 5 times upper limit of normal (ULN) at screening, or serum alanine aminotransferase (ALT) >5 times ULN at screening, or total bilirubin >= 3.0*ULN at screening (except for documented Gilbert's syndrome), as analyzed by local or central laboratory.
• Have known (previously documented) positive results for human immunodeficiency virus (HIV). Participants must have a confirmed negative HIV test result within 3 months of study entry or, if unavailable, be tested by a local laboratory during the screening period.
• Have active malignancy with the exception of nonmelanoma skin cancer, as determined by the investigator. Participants who experience relapse or progression of their underlying malignancy (for which HSCT was performed), as determined by the investigator, are not to be enrolled.
• Be undergoing treatment for acute or chronic hepatitis C
Drug: Maribavir, Drug: Valganciclovir, Other: Placebo
Cytomegalovirus (CMV)
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University of Minnesota — Minneapolis, Minnesota Site Contact - (vanbu004@umn.edu)

A Safety Study of SGN-LIV1A in Breast Cancer Patients

This is a phase I dose-escalation study to define the safety and tolerability and establish a maximum tolerated dose of SGN-LIV1A in patients with LIV1A positive locally advanced or metastatic breast cancer. LIV-1 expression must be positive by central assessment. SGN-LIV1A will be administered at a dose of 0.5 - 2.8 mg/kg intravenously on day 1 of a 3 week treatment cycle. Patients will be evaluated for radiologic response after every 2 cycles of treatment for the first 8 cycles and after every fourth cycle thereafter. Patients with stable disease or better response will be eligible to continue receiving study treatment until disease progression or unacceptable toxicity. This study will evaluate the safety and tolerability of SGN-LIV1A as both monotherapy, in all breast cancer subtypes, and in combination with trastuzumab, in patients with HER2 positive breast cancer. In the monotherapy portion of the trial, a standard 3 + 3 dose escalation trial design will be utilized. At the completion of dose escalation, expansion cohorts at or below the maximum tolerated dose may be opened to enroll approximately 15 patients with specific breast cancer subtypes. In the combination portion of the study, patients with HER2 positive disease will receive SGN-LIV1A at or below the maximum tolerated dose determined in the monotherapy portion of the trial in combination with trastuzumab, a HER2 targeted therapy. Enrollment in combination therapy expansion cohorts will continue until approximately 15 patients are treated in each cohort. The recommended dosing in the combination expansion cohorts will be determined by the sponsor in consultation with the site monitoring committee after a review of all available data from the monotherapy portion of the study.

Heather Beckwith
einho003@umn.edu
Female
18 Years and over
Phase 1
This study is NOT accepting healthy volunteers
NCT01969643
STUDY00000180
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Inclusion Criteria:

• Pathologically confirmed diagnosis of breast cancer with radiographic evidence of incurable, unresectable, locally advanced or metastatic disease (LA/MBC)
• One of the following:
• Part A: Triple-negative disease (ER/PR/HER2-negative) and received at least 2 prior cytotoxic regimens in the incurable, unresectable, LA/MBC setting; or ER-positive and/or PR-positive/HER2-negative disease and received at least 2 prior cytotoxic regimens in the incurable, unresectable, LA/MBC setting and are no longer a candidate for hormonal therapy (not enrolling new patients);
• Part B: Combination Arm: HER2-positive disease and received at least 2 prior cytotoxic regimens in the incurable, unresectable, LA/MBC setting (not enrolling new patients);
• Part C: Triple-negative disease and received 2-4 prior non-hormonally-directed therapies in the MBC setting (not enrolling new patients);
• Part D and Part E (dose-expansion cohort): Triple-negative disease and received 1 prior non-hormonally-directed or cytotoxic therapy in the MBC setting; or
• Part E: HR+(ER-positive and/or PR-positive)/HER2-negative disease who are chemotherapy-eligible and not considered a candidate for further hormonal therapy. Must have received no more than 1 prior non-hormonally-directed or cytotoxic therapy in the LA/MBC setting.
• Part F: All of the following:
• Triple negative breast cancer
• No prior cytotoxic chemotherapy for unresectable locally advanced or metastatic stage disease
• Tumor tissue PD-L1 expression CPS <10 expression
• Parts A, B, C, and D: Newly obtained or archived tumor tissue biopsy, must be collected for central pathology determination of LIV-1 expression
• Parts E and F: Archival or fresh baseline tumor sample is required.
• Measurable disease
• Eastern Cooperative Oncology Group performance status 0 or 1
• Combination Arm: adequate heart function
Exclusion Criteria:

• Pre-existing neuropathy Grade 2 or higher
• Parts A, B, C, and D: Cerebral/meningeal disease that is related to the underlying malignancy and has not been definitively treated. Parts E and F: Known or suspected cerebral/meningeal metastasis that has not been definitively treated.
• Prior treatment with LV or prior treatment with an MMAE-containing therapy
• Combination Arm: hypersensitivity to trastuzumab
Drug: ladiratuzumab vedotin, Drug: Trastuzumab
Breast Cancer
Monomethyl auristatin E, Antibody-drug conjugate, Drug therapy, Metastatic, LIV-1 protein, human, Trastuzumab, Ladiratuzumab vedotin, hLIV22-vcMMAE, Seattle Genetics
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University of Minnesota — Minneapolis, Minnesota Seattle Genetics Trial Information Support - (clinicaltrials@seagen.com)
Virginia Piper Cancer Institute — Minneapolis, Minnesota Seattle Genetics Trial Information Support - (clinicaltrials@seagen.com)

A Registry for Participants With Chronic Hypoparathyroidism (PARADIGHM)

All
Not specified
This study is NOT accepting healthy volunteers
NCT01922440
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Inclusion Criteria:
1. Participants diagnosed with chronic hypoparathyroidism, ie, hypoparathyroidism with a duration of longer than 6 months, including: 1. Adult participants (greater than or equal to [>=] 18 years of age) who are receiving for chronic hypoparathyroidism any of the following options: standard therapy, standard therapy plus rhPTH(1-84), or rhPTH(1-84) therapy alone. 2. Pediatric participants (less than [<] 18 years of age) who are receiving for chronic hypoparathyroidism any of the following options: standard therapy, standard therapy plus rhPTH(1-84), or rhPTH(1-84) therapy alone.
Exclusion Criteria:
1. Participants or legally acceptable representatives unable to provide informed consent. 2. Participants using rhPTH(1-34) or used rhPTH(1-34) for more than 2 years and in the last 3 months. 3. Participants currently enrolled in an interventional clinical study (whether or not the study is related to hypoparathyroidism). Note that this does not include participants enrolled in other observational registries. 4. History of hypoparathyroidism resulting from a known activating mutation in the CaSR gene. 5. History of hypoparathyroidism resulting from impaired responsiveness to PTH (pseudohypoparathyroidism).
Drug: Combination product (Natpara) and drug or supplements [Disease and drug registry]
Chronic Hypoparathyroidism
Chronic Hypoparathyroidism, rhPTH(1-84), Observational study, parathyroid hormone (PTH), Drug registry, rhPTH(1-34)
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University of Minnesota — Minneapolis, Minnesota Site Contact - (HARI0049@UMN.EDU)

Idiopathic Pulmonary Fibrosis and Interstitial Lung Disease Prospective Outcomes Registry (IPF/ILD-PRO)

Idiopathic Pulmonary Fibrosis Prospective Outcomes (IPF-PRO) Registry is a prospective registry that will collect information regarding the natural history, health care interactions, participant reported questionnaire data to assess quality of life of IPF participants, and the methods of treatment of participants with a diagnosis of idiopathic pulmonary fibrosis (IPF) established at the enrolling centers. In addition, blood samples will be collected and banked for future research projects.

Hyun Kim
kimxx015@umn.edu
All
30 Years and over
This study is NOT accepting healthy volunteers
NCT01915511
1408M52921
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Inclusion Criteria:

• Willing and able to provide informed consent
• Established a new diagnosis of IPF by the enrolling subspecialty center (as defined by ATS/ERS/JRS/ALAT criteria)
• Age 30 years or older, or
• Diagnosis of a non-IPF ILD of any duration, including, but not limited to Idiopathic Non-Specific Interstitial, Pneumonia (iNSIP), Unclassifiable Idiopathic Interstitial Pneumonias (IIPs), Interstitial Pneumonia with Autoimmune Features (IPAF), Autoimmune ILDs such as Rheumatoid Arthritis (RA-ILD) and Systemic Sclerosis (SSc-ILD), Chronic Hypersensitivity Pneumonitis (HP), Sarcoidosis or Exposure-related ILDs such as asbestosis with progressive phenotype
Exclusion Criteria:

• Malignancy, treated or untreated, other than skin or early stage prostate cancer, within the past 5 years
• Currently listed for lung transplantation at the time of enrollment
• Currently enrolled in a clinical trial at the time of enrollment in this registry
Idiopathic Pulmonary Fibrosis, Interstitial Lung Disease
Idiopathic pulmonary fibrosis, Pulmonary fibrosis, IPF, Registry, 1199.174, Interstitial Lung Disease, ILD, Interstitial Lung Disease with Progressive Phenotype
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University of Minnesota — Minneapolis, Minnesota Mandi DeGrote - (carl1032@umn.edu)

International Guillain-Barré Syndrome Outcome Study (IGOS)

All
Not specified
This study is NOT accepting healthy volunteers
NCT01582763
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Inclusion Criteria:

• Fulfil diagnostic criteria for GBS of National Institute of Neurological Disorders and Stroke (NINDS). Patients with Miller Fisher syndrome and all other variants of GBS, including overlap syndromes, can be included.
• Inclusion of all males and females of all ages, independent of disease severity and treatment
• Inclusion within two weeks of onset of weakness
• Inclusion of patients transferred from another hospital if the stay in the first hospital was less than one week
• Opportunity to conduct a follow-up of at least one year
• Informed consent of patient or, in case of children, of parents or legal guardians
Exclusion Criteria:

• There are no exclusion criteria
Guillain-Barré Syndrome, Miller Fisher Syndrome
Guillain-Barré syndrome, Polyneuropathy, Autoimmune Diseases, Immune System Diseases, Neuromuscular Diseases, Outcome, Quality of life, Disability, Prognostic Determinants, Treatment, Immunoglobulins, Prognosis, Infections, Anti-ganglioside antibodies, Genetic polymorphisms, Electrophysiology, Cerebrospinal Fluid, Serum
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University of Minnesota — Minneapolis, Minnesota

Natural History Study of and Genetic Modifiers in Spinocerebellar Ataxias

All
6 Years and over
This study is NOT accepting healthy volunteers
NCT01060371
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Inclusion Criteria:

• Presence of symptomatic ataxic disease
• Definite molecular diagnosis of SCA 1, 2,3,or 6 either in the subject or another affected family member
• Willingness to participate in the study and ability to give informed consent.
• Age 6 years and above
Exclusion Criteria:

• Known recessive, X-linked and mitochondrial ataxias
• Exclusion of SCA 1, 2, 3 and 6 by previous DNA testing,
• A lack of willingness to participate in the study
Genetic: All Participants
Spinocerebellar Ataxia Type 1, Spinocerebellar Ataxia Type 2, Spinocerebellar Ataxia Type 3, Spinocerebellar Ataxia Type 6
Spinocerebellar Ataxia, Natural History, Genetic Modifiers, DNA testing
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University of Minnesota — Minneapolis, Minnesota

I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer (I-SPY)

To determine whether adding experimental agents to standard neoadjuvant paclitaxel (with or without trastuzumab), doxorubicin, and cyclophosphamide increases the probability of pathologic complete response (pCR) over standard neoadjuvant chemotherapy for each biomarker signature established at trial entry, and to determine for each experimental agent used, the predictive probability of success in a subsequent phase 3 trial for each possible biomarker signature.

Douglas Yee, MD
yeexx006@umn.edu
All
18 Years and over
Phase 2
This study is NOT accepting healthy volunteers
NCT01042379
STUDY00011111
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Inclusion Criteria:

• Histologically confirmed invasive cancer of the breast
• Clinically or radiologically measureable disease in the breast after diagnostic biopsy, defined as longest diameter greater than or equal to 25 mm (2.5cm)
• No prior cytotoxic regimens are allowed for this malignancy. Patients may not have had prior chemotherapy or prior radiation therapy to the ipsilateral breast for this malignancy. Prior bis-phosphonate therapy is allowed
• Age ≥18 years
• ECOG performance status 0-1
• Willing to undergo core biopsy of the primary breast lesion to assess baseline biomarkers
• Non-pregnant and non-lactating
• No ferromagnetic prostheses. Patients who have metallic surgical implants that are not compatible with an MRI machine are not eligible.
• Ability to understand and willingness to sign a written informed consent (I-SPY TRIAL Screening Consent)
• Eligible tumors must meet one of the following criteria: Stage II or III, or T4, any N, M0, including clinical or pathologic inflammatory cancer or Regional Stage IV, where supraclavicular lymph nodes are the only sites metastasis
• Any tumor ER/PgR status, any HER-2/neu status as measured by local hospital pathology laboratory and meets any tumor assay profile described in protocol section 4.1.2F
• Normal organ and marrow function: Leukocytes ≥ 3000/μL, Absolute neutrophil count ≥ 1500/μL, Platelets ≥ 100,000/μL, Total bilirubin within normal institutional limits, unless patient has Gilbert's disease, for which bilirubin must be ≤ 2.0 x ULN, AST(SGOT)/ALT (SGPT) ≤ 1.5 x institutional ULN, creatinine < 1.5 x institutional ULN
• No uncontrolled or severe cardiac disease. Baseline ejection fraction (by nuclear imaging or echocardiography) must by ≥ 50%
• No clinical or imaging evidence of distant metastases by PA and Lateral CXR, Radionuclide Bone scan, and LFTs including total bilirubin, ALT, AST, and alkaline phosphatase
• Tumor assay profile must include on of the following: MammaPrint High, any ER status, any HER2 status, or MammaPrint Low, ER negative (<5%), any HER2 status, or MammaPrint Low, ER positive, HER2/neu positive by any one of the three methods used (IHC, FISH, TargetPrint™)
• Ability to understand and willingness to sign a written informed consent document (I-SPY 2 TRIAL Consent #2)
Exclusion Criteria:

• Use of any other investigational agents within 30 days of starting study treatment
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to the study agent or accompanying supportive medications.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Drug: Standard Therapy, Drug: AMG 386 with or without Trastuzumab, Drug: AMG 479 (Ganitumab) plus Metformin, Drug: MK-2206 with or without Trastuzumab, Drug: AMG 386 and Trastuzumab, Drug: T-DM1 and Pertuzumab, Drug: Pertuzumab and Trastuzumab, Drug: Ganetespib, Drug: ABT-888, Drug: Neratinib, Drug: PLX3397, Drug: Pembrolizumab - 4 cycle, Drug: Talazoparib plus Irinotecan, Drug: Patritumab and Trastuzumab, Drug: Pembrolizumab - 8 cycle, Drug: SGN-LIV1A, Drug: Durvalumab plus Olaparib, Drug: SD-101 + Pembrolizumab, Drug: Tucatinib plus trastuzumab and pertuzumab, Drug: Cemiplimab, Drug: Cemiplimab plus REGN3767, Drug: Trilaciclib with or without trastuzumab + pertuzumab, Drug: SYD985 ([vic-]trastuzumab duocarmazine), Drug: Oral Paclitaxel + Encequidar + Dostarlimab (TSR-042) + Carboplatin with or without trastuzumab, Drug: Oral Paclitaxel + Encequidar + Dostarlimab (TSR-042) with or without trastuzumab
Breast Neoplasms, Breast Cancer, Breast Tumors, Angiosarcoma
Neoadjuvant, Breast, Cancer, Neoplasm, Adaptive, pCR, Pathologic Complete Response, Biomarkers signature, MRI Volume, Endocrine Therapy, Chemotherapy, Immunotherapy
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University of Minnesota — Minneapolis, Minnesota

A Study of Oral LOXO-292 (Selpercatinib) in Pediatric Participants With Advanced Solid or Primary Central Nervous System (CNS) Tumors (LIBRETTO-121)

Emily Greengard
emilyg@umn.edu
All
6 Months to 21 Years old
Phase 1/Phase 2
This study is NOT accepting healthy volunteers
NCT03899792
STUDY00008874
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Inclusion Criteria:

• Advanced or metastatic solid or primary CNS tumor which has failed standard of care therapies
• Evidence of an activating RET gene alteration in the tumor and/or blood
• Measurable or non-measurable disease
• Karnofsky (participants 16 years and older) or Lansky (participants younger than 16) performance score of at least 50
• Participant with primary CNS tumors or cerebral metastases must be neurologically stable for 7 days prior and must not have required increasing doses of steroids within the last 7 days
• Adequate hematologic, hepatic and renal function.
• Ability to receive study drug therapy orally or via gastric access
• Willingness of men and women of reproductive potential to observe conventional and effective birth control
Exclusion Criteria:

• Major surgery within two weeks prior to planned start of LOXO-292
• Clinically significant, uncontrolled cardiac, cardiovascular disease or history of myocardial infarction within 6 months prior to planned start of LOXO-292
• Active uncontrolled systemic bacterial, viral, fungal or parasitic infection
• Clinically significant active malabsorption syndrome
• Pregnancy or lactation
• Uncontrolled symptomatic hyperthyroidism or hypothyroidism (i.e. the participant required a modification to current thyroid medication in the 7 days before start of LOXO-292)
• Uncontrolled symptomatic hypercalcemia or hypocalcemia
• Known hypersensitivity to any of the components of the investigational agent, LOXO-292 or Ora-Sweet® SF and OraPlus®, for participants who will receive LOXO-292 suspension
• Prior treatment with a selective RET inhibitor(s) (including investigational selective RET inhibitor[s])
Drug: LOXO-292
Medullary Thyroid Cancer, Infantile Myofibromatosis, Infantile Fibrosarcoma, Papillary Thyroid Cancer, Soft Tissue Sarcoma
Loxo, LOXO-292, KIF5B-RET, M918T, CCDC6-RET, RET-PTC1, NCOA4-RET, RET-PTC, RET-PTC3, RET-PTC4, PRKAR1A-RET, RET-PTC2, GOLGA5-RET, RET-PTC5, ERC1-RET, KTN1-RET, RET-PTC8, HOOK3-RET, PCM1-RET, TRIM24-RET, RET-PTC6, TRIM27-RET, TRIM33-RET, RET-PTC7, AKAP13-RET, FKBP15-RET, SPECC1L-RET, TBL1XR1-RET, BCR-RET, FGRF1OP-RET, RFG8-RET, RET-PTC9, ACBD5-RET, MYH13-RET, CUX1-RET, KIAA1468-RET, FRMD4A-RET, SQSTM1-RET, AFAP1L2-RET, PPFIBP2-RET, EML4-RET, PARD3-RET, G533C, C609F, C609G, C609R, C609S, C609Y, C611F, C611G, C611S, C611Y, C611W, C618F, C618R, C618S, C620F, C620R, C620S, C630R, C630Y, D631Y, C634F, C634G, C634R, C634S, C634W, C634Y, K666E, E768D, L790F, V804L, V804M, A883F, S891A, R912P, CLIP1-RET, Y806C, RET fusion, RET alteration, RET mutation, RET rearrangement, RET translocation, Neoplasms by Site, Neoplasms, Non-Small Cell Lung Cancer, Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Cancer of Lung, Cancer of the Lung, Lung Cancer, Neoplasms, Lung, Neoplasms, Pulmonary, Pulmonary Cancer, Pulmonary Neoplasms, Respiratory Tract Neoplasms, Lung Diseases, Respiratory Tract Diseases, Carcinoma, Bronchogenic, Bronchial Neoplasms, Medullary Thyroid Cancer, Papillary Thyroid Cancer, Thyroid Diseases, Thyroid Neoplasms, Cancer of the Thyroid, Cancer of Thyroid, Neoplasms, Thyroid, Thyroid Adenoma, Thyroid Cancer, Thyroid Carcinoma, Endocrine System Diseases, Endocrine Gland Neoplasms, Head and Neck Neoplasms, Thoracic Neoplasms, CNS tumor, Primary CNS tumor, Colonic Neoplasms, Cancer of Colon, Cancer of the Colon, Colon Cancer, Colon Neoplasms, Colonic Cancer, Neoplasms, Colonic, Malignant tumor of Breast, Mammary Cancer, Mammary Carcinoma, Human, Mammary Neoplasm, Human, Neoplasms, Breast, Tumors, Breast, Human Mammary Carcinoma, Malignant Neoplasm of Breast, Breast Carcinoma, Breast Tumors, Cancer of the Breast, Breast Neoplasms, Breast Cancer, RET Inhibitor, MTC, NSCLC, Soft tissue sarcoma, Infantile Myofibromatosis, Infantile Fibrosarcoma
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University of Minnesota Hospital — Minneapolis, Minnesota

Pulmonary Hypertension Association Registry (PHAR)

Thenappan Thenappan
tthenapp@umn.edu
All
Not specified
This study is NOT accepting healthy volunteers
NCT04071327
1702M07281
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Inclusion Criteria:

• All age groups
• Written informed consent
• Pulmonary arterial hypertension (PAH), chronic thromboembolic pulmonary hypertension (CTEPH), or pediatric PH due to developmental lung disease
• Within 6 months of first outpatient visit at a PH Care Center
Exclusion Criteria:

• Diagnosis of WSPH Group 2 pulmonary hypertension
• Diagnosis of WSPH Group 3 pulmonary hypertension, except PH due to developmental lung disease
• Diagnosis of WSPH Group 5 pulmonary hypertension
Pulmonary Arterial Hypertension, Chronic Thromboembolic Pulmonary Hypertension, Pulmonary Hypertension
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University of Minnesota Health — Minneapolis, Minnesota Thenappan Thenappan, MD - (tthenapp@umn.edu) Gretchen Piechel - (gpeichel@umn.edu)

CAMPFIRE: A Study of Ramucirumab (LY3009806) in Children and Young Adults With Synovial Sarcoma

All
12 Months to 29 Years old
Phase 1/Phase 2
This study is NOT accepting healthy volunteers
NCT04145700
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Inclusion Criteria:

• Participants must have discontinued all previous treatments for cancer or investigational agents ≥7 days after the last dose or per the type of previous treatment as stated in the protocol and must have recovered from the acute effects to ≤Grade 2 for alopecia and decreased tendon reflex and to ≤Grade 1 for all other effects at the time of enrollment, unless otherwise noted. Consult with the Lilly clinical research physician or scientist for the appropriate length of time prior to the first dose of study treatment.
• Participants with relapsed, recurrent, or refractory SS.
• Participants must:
• Have measurable disease by Response Evaluation Criteria in Solid Tumors, Version (RECIST) 1.1.
• have received at least one prior line of systemic treatment (including neoadjuvant and adjuvant chemotherapy) that contains ifosfamide and/or doxorubicin, or any approved therapies for which they are eligible, unless the patient is not a suitable candidate for the approved therapy.
• not be eligible for surgical resection at time of enrollment.
• Adequate cardiac function, defined as: Shortening fraction of ≥27% by echocardiogram, or ejection fraction of ≥50% by gated radionuclide study.
• Adequate blood pressure (BP) control, defined as:
• Participants ≥18 years: Controlled hypertension defined as systolic BP ≤150 millimeters of mercury (mmHg) or diastolic BP ≤90 mmHg where standard medical management is permitted. Please note that ≥2 serial BP readings should be obtained and averaged to determine baseline BP.
• Participants <18 years: A BP ≤95th percentile for age, height, and gender measured as described in National High Blood Pressure Education Program Working Group (NHBPEPWG) on High Blood Pressure in Children and Adolescents (2004), where standard medical management is permitted. Please note that ≥2 serial BP readings should be obtained and averaged to determine baseline BP.
• Adequate hematologic function, as defined as:
• Absolute neutrophil count (ANC): ≥750/microliters (µL) granulocyte-colony stimulating factor (G-CSF) permitted up to 48 hours prior. Participants with documented history of benign ethnic neutropenia or other conditions could be considered with a lower ANC after discussion with and approval from the Lilly clinical research physician or scientist.
• Platelets: ≥75,000/cubic millimeters. Platelet transfusion permitted up to 72 hours prior.
• Hemoglobin: ≥8 grams per deciliter (g/dL) (≥80 g/liter). Transfusions to increase the participant's hemoglobin level to at least 8 g/dL are permitted; however, study treatment must not begin until 7 days after the transfusion, and complete blood count criteria for eligibility are confirmed within 24 hr of first study dose.
• Adequate renal function, as defined as:
• Creatinine clearance or radioscope glomerular filtration rate (GFR) ≥60 milliliters/minute/meters squared OR serum creatinine meeting the following parameters:
• for participants ≥18 years of age serum creatinine ≤1.5×upper limit of normal (ULN);
• for participants <18 years of age, serum creatinine based on age/gender as follows: Age 1 to <2 years maximum serum creatinine 0.6, Age 2 to <6 years maximum serum creatinine 0.8, Age 6 to <10 years maximum serum creatinine 1.0, Age 10 to <13 years maximum serum creatinine 1.2, Age 13 to <16 years maximum serum creatinine 1.5 for males and 1.4 for females, Age 16 to <18 years maximum serum creatinine 1.7 for males and 1.4 for females.
• Urine protein meeting the following parameters:
• for participants ≥18 years of age: <2+ on dipstick or routine urinalysis. If urine dipstick or routine analysis indicates proteinuria ≥2+, then a 24-hour urine must be collected and must demonstrate <2 grams of protein in 24 hours to allow participation in the study.
• for participants <18 years of age: ≤30 milligrams per deciliter urine analysis or <2+ on dipstick. If urine dipstick or routine analysis indicates proteinuria ≥2+, then a 24-hour urine must be collected and must demonstrate <1 g of protein in 24 hours to allow participation in the study.
• Adequate liver function:
• Total bilirubin: ≤1.5×ULN. Except participants with document history of Gilbert Syndrome who must have a total bilirubin level of <3.0×ULN.
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST): ≤2.5×ULN OR ≤5.0×ULN if the liver has tumor involvement.
• The participant has an adequate coagulation function as defined by International Normalized Ratio ≤1.5 or prothrombin time ≤1.5×ULN, and partial thromboplastin time ≤1.5×ULN if not receiving anticoagulation therapy. For participants receiving anticoagulants, exceptions to these coagulation parameters are allowed if they are within the intended or expected range for their therapeutic use. Participants must have no history of clinically significant active bleeding (defined as within 14 days of first dose of study drug) or pathological condition that carries a high risk of bleeding (for example, tumor involving major vessels or known esophageal varices).
• The participant has adequate hematologic and organ function ≤1 week (7 days) prior to first dose of study drug.
• Female participants of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to randomization. Male and female participants must agree to use highly effective contraception for the duration of the study and up to 3 months following the last dose of ramucirumab and 6 months following the last dose of docetaxel and gemcitabine in order to prevent pregnancy.
Exclusion Criteria:

• Participants with severe and/or uncontrolled concurrent medical disease or psychiatric illness/social situation that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol.
• Participants who have active infections requiring therapy.
• Participants with an active fungal, bacterial, and/or known severe viral infection including, but not limited to, human immunodeficiency virus (HIV) or viral (A, B, or C) hepatitis (screening is not required).
• Participants who have had allogeneic bone marrow or solid organ transplant are excluded.
• Surgery: Participants who have had, or are planning to have, the following invasive procedures are not eligible:
• Major surgical procedure, laparoscopic procedure, or significant traumatic injury within 28 days prior to enrollment.
• Central line placement or subcutaneous port placement is not considered major surgery.
• Core biopsy, fine needle aspirate, and bone marrow biopsy/aspirate are not considered major surgeries.
• Surgical or other wounds must be adequately healed prior to enrollment.
• Bleeding and thrombosis:
• Participants with evidence of active bleeding or a history of significant (≥Grade 3) bleeding event within 3 months prior to enrollment are not eligible.
• Participants with a bleeding diathesis or vasculitis are not eligible.
• Participants with known or prior history in the prior 3 months of esophageal varices are not eligible.
• Participants with a history of deep vein thrombosis requiring medical intervention (including pulmonary embolism) within 3 months prior to study enrollment are not eligible.
• Participants with a history of hemoptysis or other signs of pulmonary hemorrhage within 3 months prior to study enrollment are not eligible.
• Cardiac:
• Participants with a history of central nervous system (CNS) arterial/venous thromboembolic events (VTEs) including transient ischemic attack (TIA) or cerebrovascular accident (CVA) within 6 months prior to study enrollment are not eligible.
• Participants with myocardial infarction or unstable angina within the prior 6 months.
• Participants with New York Heart Association Grade 2 or greater congestive heart failure (CHF).
• Participants with serious and inadequately controlled cardiac arrhythmia.
• Participants with significant vascular disease (eg, aortic aneurysm, history of aortic dissection).
• Participants with clinically significant peripheral vascular disease.
• Participants who have a history of fistula, gastrointestinal (GI) ulcer or perforation, or intra-abdominal abscess within 3 months of study enrollment are not eligible.
• Participants with a history of hypertensive crisis or hypertensive encephalopathy within 6 months of study enrollment are not eligible.
• Participants who have non-healing wound, unhealed or incompletely healed fracture, or a compound (open) bone fracture at the time of enrollment are not eligible.
• Participants previously treated and progressed on combination gemcitabine and docetaxel regimen. Participants who received combination as maintenance therapy, without progression, would be eligible.
• Participants with a known hypersensitivity to ramucirumab, gemcitabine, docetaxel, or agents formulated with Polysorbate 80.
• Hepatic impairment:
• Severe liver cirrhosis Child-Pugh Class B (or worse).
• Cirrhosis with a history of hepatic encephalopathy.
• Clinically meaningful ascites resulting from cirrhosis and requiring ongoing treatment with diuretics and/or paracentesis.
• History of hepatorenal syndrome.
• The participant has a bowel obstruction, history or presence of inflammatory enteropathy or extensive intestinal resection (eg, hemicolectomy or extensive small intestine resection with chronic diarrhea), Crohn's disease, ulcerative colitis, or chronic diarrhea.
• The participant has symptomatic interstitial pneumonia or pulmonary fibrosis (or consistent findings of interstitial pneumonia/pulmonary fibrosis on imaging).
• Participants with central nervous system (CNS) involvement are ineligible.
Drug: Ramucirumab, Drug: Gemcitabine, Drug: Docetaxel
Synovial Sarcoma
soft tissue sarcoma, adolescents and young adults (AYAs), adolescent
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University of Minnesota Hospital — Minneapolis, Minnesota

CAMPFIRE: A Study of Ramucirumab (LY3009806) in Children and Young Adults With Desmoplastic Small Round Cell Tumor

All
12 Months to 29 Years old
Phase 1/Phase 2
This study is NOT accepting healthy volunteers
NCT04145349
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Inclusion Criteria:

• Participants must have discontinued all previous treatments for cancer or investigational agents ≥7 days after the last dose or per the type of previous treatment as stated in the protocol and must have recovered from the acute effects to ≤Grade 2 for alopecia and decreased tendon reflex and to ≤Grade 1 for all other effects at the time of enrollment, unless otherwise noted. Consult with the Lilly clinical research physician or scientist for the appropriate length of time prior to the first dose of study treatment.
• Participants with relapsed, recurrent, or refractory DSRCT.
• Participants must:
• Have measurable disease by Response Evaluation Criteria in Solid Tumors, Version (RECIST) 1.1.
• Have received at least one prior line of systemic treatment (including neoadjuvant and adjuvant chemotherapy). This prior treatment must include approved therapies for which they are eligible, unless the participant is not a suitable candidate for the approved therapy.
• Not be eligible for surgical resection at time of enrollment.
• Adequate cardiac function, defined as: Shortening fraction of ≥27% by echocardiogram, or ejection fraction of ≥50% by gated radionuclide study.
• Adequate blood pressure (BP) control, defined as:
• Participants ≥18 years: Controlled hypertension defined as systolic BP ≤150 millimeters of mercury (mmHg) or diastolic BP ≤90 mmHg where standard medical management is permitted. Please note that ≥2 serial BP readings should be obtained and averaged to determine baseline BP.
• Participants <18 years: A BP ≤95th percentile for age, height, and gender measured as described in National High Blood Pressure Education Program Working Group (NHBPEPWG) on High Blood Pressure in Children and Adolescents (2004), where standard medical management is permitted. Please note that ≥2 serial BP readings should be obtained and averaged to determine baseline BP.
• Adequate hematologic function, as defined as:
• Absolute neutrophil count (ANC): ≥750/microliters (µL) granulocyte-colony stimulating factor (G-CSF) permitted up to 48 hours prior. Participants with documented history of benign ethnic neutropenia or other conditions could be considered with a lower ANC after discussion with and approval from the Lilly clinical research physician or scientist.
• Platelets: ≥75,000/cubic millimeters. Platelet transfusion permitted up to 72 hours prior.
• Hemoglobin: ≥8 grams per deciliter (g/dL) (≥80 g/liter). Transfusions to increase the participant's hemoglobin level to at least 8 g/dL are permitted; however, study treatment must not begin until 7 days after the transfusion, and complete blood count criteria for eligibility are confirmed within 24 hr of first study dose.
• Adequate renal function, as defined as:
• Creatinine clearance or radioscope glomerular filtration rate (GFR) ≥60 milliliters/minute/meters squared OR serum creatinine meeting the following parameters:
• for participants ≥18 years of age serum creatinine ≤1.5×upper limit of normal (ULN);
• for participants <18 years of age, serum creatinine based on age/gender as follows: Age 1 to <2 years maximum serum creatinine 0.6, Age 2 to <6 years maximum serum creatinine 0.8, Age 6 to <10 years maximum serum creatinine 1.0, Age 10 to <13 years maximum serum creatinine 1.2, Age 13 to <16 years maximum serum creatinine 1.5 for males and 1.4 for females, Age 16 to <18 years maximum serum creatinine 1.7 for males and 1.4 for females.
• Urine protein meeting the following parameters:
• for participants ≥18 years of age: <2+ on dipstick or routine urinalysis. If urine dipstick or routine analysis indicates proteinuria ≥2+, then a 24-hour urine must be collected and must demonstrate <2 grams of protein in 24 hours to allow participation in the study.
• for participants <18 years of age: ≤30 milligrams per deciliter urine analysis or <2+ on dipstick. If urine dipstick or routine analysis indicates proteinuria ≥2+, then a 24-hour urine must be collected and must demonstrate <1 g of protein in 24 hours to allow participation in the study.
• Adequate liver function:
• Total bilirubin: ≤1.5×ULN. Except participants with document history of Gilbert Syndrome who must have a total bilirubin level of <3.0×ULN.
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST): ≤2.5×ULN OR ≤5.0×ULN if the liver has tumor involvement.
• The participant has an adequate coagulation function as defined by International Normalized Ratio ≤1.5 or prothrombin time ≤1.5×ULN, and partial thromboplastin time ≤1.5×ULN if not receiving anticoagulation therapy. For participants receiving anticoagulants, exceptions to these coagulation parameters are allowed if they are within the intended or expected range for their therapeutic use. Participants must have no history of clinically significant active bleeding (defined as within 14 days of first dose of study drug) or pathological condition that carries a high risk of bleeding (for example, tumor involving major vessels or known esophageal varices).
• The participant has adequate hematologic and organ function ≤1 week (7 days) prior to first dose of study drug.
• Female participants of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to randomization. Male and female participants must agree to use highly effective contraception for the duration of the study and up to 3 months following the last dose of ramucirumab and vinorelbine, and 12 months following the last dose of cyclophosphamide in order to prevent pregnancy.
Exclusion Criteria:

• Participants with severe and/or uncontrolled concurrent medical disease or psychiatric illness/social situation that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol.
• Participants who have active infections requiring therapy.
• Participants with an active fungal, bacterial, and/or known severe viral infection including, but not limited to, human immunodeficiency virus (HIV) or viral (A, B, or C) hepatitis (screening is not required).
• Participants who have had allogeneic bone marrow or solid organ transplant are excluded.
• Surgery: Participants who have had, or are planning to have, the following invasive procedures are not eligible:
• Major surgical procedure, laparoscopic procedure, or significant traumatic injury within 28 days prior to enrollment.
• Central line placement or subcutaneous port placement is not considered major surgery.
• Core biopsy, fine needle aspirate, and bone marrow biopsy/aspirate are not considered major surgeries.
• Surgical or other wounds must be adequately healed prior to enrollment.
• Bleeding and thrombosis:
• Participants with evidence of active bleeding or a history of significant (≥Grade 3) bleeding event within 3 months prior to enrollment are not eligible.
• Participants with a bleeding diathesis or vasculitis are not eligible.
• Participants with known or prior history in the prior 3 months of esophageal varices are not eligible.
• Participants with a history of deep vein thrombosis requiring medical intervention (including pulmonary embolism) within 3 months prior to study enrollment are not eligible.
• Participants with a history of hemoptysis or other signs of pulmonary hemorrhage within 3 months prior to study enrollment are not eligible.
• Cardiac:
• Participants with a history of central nervous system (CNS) arterial/venous thromboembolic events (VTEs) including transient ischemic attack (TIA) or cerebrovascular accident (CVA) within 6 months prior to study enrollment are not eligible.
• Participants with myocardial infarction or unstable angina within the prior 6 months.
• Participants with New York Heart Association Grade 2 or greater congestive heart failure (CHF).
• Participants with serious and inadequately controlled cardiac arrhythmia.
• Participants with significant vascular disease (eg, aortic aneurysm, history of aortic dissection).
• Participants with clinically significant peripheral vascular disease.
• Participants who have a history of fistula, gastrointestinal (GI) ulcer or perforation, or intra-abdominal abscess within 3 months of study enrollment are not eligible.
• Participants with a history of hypertensive crisis or hypertensive encephalopathy within 6 months of study enrollment are not eligible.
• Participants who have non-healing wound, unhealed or incompletely healed fracture, or a compound (open) bone fracture at the time of enrollment are not eligible.
• Participants previously treated and progressed on combination cyclophosphamide and vinorelbine regimen. Participants who received combination as maintenance therapy, without progression, would be eligible.
• Participants with a known hypersensitivity to ramucirumab, cyclophosphamide, vinorelbine or any of the excipients of the medicinal products.
• Hepatic impairment:
• Severe liver cirrhosis Child-Pugh Class B (or worse).
• Cirrhosis with a history of hepatic encephalopathy.
• Clinically meaningful ascites resulting from cirrhosis and requiring ongoing treatment with diuretics and/or paracentesis.
• History of hepatorenal syndrome.
• The participant has a bowel obstruction, history or presence of inflammatory enteropathy or extensive intestinal resection (eg, hemicolectomy or extensive small intestine resection with chronic diarrhea), Crohn's disease, ulcerative colitis, or chronic diarrhea.
• The participant has a urinary outflow obstruction.
• The participant has Grade 2 hematuria or non-infectious cystitis at the time of screening.
• Participants with central nervous system (CNS) involvement are ineligible.
Drug: Ramucirumab, Drug: Cyclophosphamide, Drug: Vinorelbine
Desmoplastic Small Round Cell Tumor
soft tissue sarcoma, adolescents and young adults (AYAs), adolescent
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Location Contacts
University of Minnesota Hospital — Minneapolis, Minnesota