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3289 Study Matches

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ACCESS: A Multi-Center, Phase II Trial of HLA-Mismatched Unrelated Donor Hematopoietic Cell Transplantation with Post-Transplantation Cyclophosphamide for Patients with Hematologic Malignancies (ACCESS)

HLA-Mismatched Unrelated Donor Hematopoietic Cell Transplantation With Post-Transplantation Cyclophosphamide

William Hogan
All
1 years and over
Phase 2
This study is NOT accepting healthy volunteers
2021-305092-P01-RST
21-006560
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Stratum 1 Recipient

Inclusion Criteria:


1. Age > 18 years and < 66 years (chemotherapy-based conditioning) or < 61 years (total
body irradiation [TBI]-based conditioning) at the time of signing informed consent

2. Planned MAC regimen as defined per protocol

3. Available partially HLA-MMUD (4/8-7/8 at HLA-A, -B, -C, and -DRB1 is required) with
age < 35 years

4. Product planned for infusion is PBSC

5. HCT Comorbidity Index (HCT-CI) < 5

6. One of the following diagnoses:

1. Acute myeloid leukemia (AML) acute lymphoblastic leukemia (ALL), or other acute
leukemia in 1st remission or beyond with ≤ 5% marrow blasts and no circulating
blasts or evidence of extra-medullary disease. Documentation of bone marrow
assessment will be accepted within 45 days prior to the anticipated start of
conditioning.

2. Patients with myelodysplastic syndrome (MDS) with no circulating blasts and with
< 10% blasts in the bone marrow (higher blast percentage allowed in MDS due to
lack of differences in outcomes with < 5% or 5-10% blasts in MDS). Documentation
of bone marrow assessment will be accepted within 45 days prior to the
anticipated start of conditioning.

7. Cardiac function: Left ventricular ejection fraction > 45% based on most recent
echocardiogram or multigated acquisition scan (MUGA) results

8. Estimated creatinine clearance > 60 mL/min calculated by equation

9. Pulmonary function: diffusing capacity of the lungs for carbon monoxide (DLCO)
corrected for hemoglobin > 50% and forced expiratory volume in first second (FEV1)
predicted > 50% based on most recent pulmonary function test results

10. Liver function acceptable per local institutional guidelines

11. Karnofsky performance status (KPS) of > 70%

12. Subjects ≥ 18 years of age or legally authorized representative must have the ability
to give informed consent according to applicable regulatory and local institutional
requirements.

Stratum 2 Recipient Inclusion Criteria

1. Age > 18 years at the time of signing informed consent

2. Planned NMA/RIC regimen as defined per protocol

3. Available partially HLA-MMUD (4/8-7/8 at HLA-A, -B, -C, and -DRB1 is required) with
age < 35 years

4. Product planned for infusion is PBSC

5. One of the following diagnoses:

1. Patients with acute leukemia or chronic myeloid leukemia (CML) with no
circulating blasts, no evidence of extramedullary disease, and with < 5% blasts
in the bone marrow. Documentation of bone marrow assessment will be accepted
within 45 days prior to the anticipated start of conditioning.

2. Patients with MDS with no circulating blasts and with < 10% blasts in the bone
marrow (higher blast percentage allowed in MDS due to lack of differences in
outcomes with < 5% or 5-10% blasts in MDS.) Documentation of bone marrow
assessment will be accepted within 45 days prior to the anticipated start of
conditioning.

3. Patients with chronic lymphocytic leukemia (CLL) or other leukemias (including
prolymphocytic leukemia) with chemosensitive disease at time of transplantation

4. Patients with lymphoma with chemosensitive disease at the time of transplantation

6. Cardiac function: Left ventricular ejection fraction > 45% based on most recent
echocardiogram or MUGA results with no clinical evidence of heart failure

7. Estimated creatinine clearance > 60 mL/min calculated by equation

8. Pulmonary function: DLCO corrected for hemoglobin > 50% and FEV1 predicted > 50% based
on most recent pulmonary function test results

9. Liver function acceptable per local institutional guidelines

10. KPS of > 60%

11. Subjects ≥ 18 years of age or legally authorized representative must have the ability
to give informed consent according to applicable regulatory and local institutional
requirements.

Stratum 3 Recipient Inclusion Criteria

1. Age > 1 years and < 21 years at the time of signing informed consent

2. Partially HLA-MMUD (4/8-7/8 at HLA-A, -B, -C, and -DRB1 is required) with age < 35
years

3. Product planned for infusion is BM

4. Planned MAC regimen as defined per protocol

5. One of the following diagnosis:

1. AML in 1st remission or beyond with ≤ 5% marrow blasts, no circulating blasts or
evidence of extra-medullary disease. Pre-transplant MRD testing will be performed
as per standard of practice at the treating institution. Patients with any MRD
status are eligible and should be enrolled at the discretion of provider.
Documentation of bone marrow assessment will be accepted within 45 days prior to
the anticipated start of conditioning.

2. Patients MDS with no circulating blasts and less than 10% blasts in the bone
marrow. Documentation of bone marrow assessment will be accepted within 45 days
prior to the anticipated start of conditioning.

3. ALL in 1st remission or beyond with ≤ 5% marrow blasts, no circulating blasts, or
evidence of extra-medullary disease. Pre-transplant MRD testing will be performed
as standard practice at the treating institution with the goal of achieving MRD
of <0.01%. Patients with any MRD status are eligible and should be enrolled at
the discretion of provider. Documentation of bone marrow assessment will be
accepted within 45 days prior to the anticipated start of conditioning.

4. Other leukemia (mixed-phenotype acute leukemia [MPAL], CML, or other leukemia) in
morphologic remission with ≤ 5% marrow blasts and no circulating blasts or
evidence of extramedullary disease. Documentation of bone marrow assessment will
be accepted within 45 days prior to the anticipated start of conditioning.

5. Chemotherapy sensitive lymphoma in at least partial remission (PR)

6. KPS or Lansky performance score ≥ 70%

7. Cardiac function: Left ventricular ejection fraction of ≥ 50% and shortening fraction
of ≥ 27% based on most recent echocardiogram

8. Glomerular Filtration Rate (GFR) of ≥ 60ml/min/1.73m2 measured by nuclear medicine
scan or calculated from a 24 hour urine collection

9. Pulmonary function: DLCO corrected for hemoglobin, FEV1, and Forced Vital Capacity
(FVC) of ≥50% if able to perform pulmonary function tests. If unable to perform
pulmonary function tests, must have a resting pulse oximetry of >92% without
supplemental oxygen.

10. Hepatic: Total bilirubin ≤ 2.5 mg/dL and alanine aminotransferase (ALT), aspartate
aminotransferase (AST) < 3x the upper limit of normal

11. Legal guardian permission must be obtained for subjects < 18 years of age. Pediatric
subjects will be included in age appropriate discussion in order to obtain assent.

12. Subjects ≥ 18 years of age or legally authorized representative must have the ability
to give informed consent according to applicable regulatory and local institutional
requirements.

Donor
Inclusion Criteria:


1. Must be unrelated to the subject and high-resolution HLA-matched at 4/8, 5/8, 6/8, or
7/8 (HLA-A, -B, -C, and -DRB1)

2. Donor must be typed at high-resolution for a minimum of HLA-A, -B, -C, -DRB1, -DQB1,
and -DPB1

3. Age > 18 years and < 35 years at the time of signing informed consent

4. Meet the donor registries' medical suitability requirements for PBSC or BM donation

5. Must undergo eligibility screening according to current Food and Drug Administration
(FDA) requirements. Donors who do not meet one or more of the donor screening
requirements may donate under urgent medical need.

6. Must agree to donate PBSC (or BM for stratum 3)

7. Must have the ability to give standard (non-study) informed consent according to
applicable donor regulatory requirements

Recipient Exclusion Criteria (Strata 1, 2 and 3):

1. Suitable HLA-matched related or 8/8 high-resolution matched unrelated donor available

2. Subject unwilling or unable to give informed consent, or unable to comply with the
protocol including required follow-up and testing

3. Primary myelofibrosis or myelofibrosis secondary to essential thrombocythemia,
polycythemia vera, or MDS with grade 4 marrow fibrosis

4. Subjects with a prior allogeneic transplant

5. Subjects with an autologous transplant within the past 3 months

6. Females who are breast-feeding or pregnant

7. Uncontrolled bacterial, viral or fungal infection at the time of the transplant
preparative regimen

8. Concurrent enrollment on other interventional GVHD clinical trial (enrollment on
supportive care trials may be allowed after discussion with Principal Investigators)

9. Subjects who undergo desensitization to reduce anti-donor HLA antibody levels prior to
transplant.

10. Patients who are HIV+ with persistently positive viral load. HIV-infected patients on
effective anti-retroviral therapy with undetectable viral load within 6 months are
eligible for this trial.

Donor
Exclusion Criteria:


1. Donor unwilling or unable to donate

2. Recipient positive anti-donor HLA antibodies against a mismatched HLA in the selected
donor determined by either:

1. a positive crossmatch test of any titer (by complement-dependent cytotoxicity or
flow cytometric testing) or

2. the presence of anti-donor HLA antibody to any HLA locus (HLA-A, -B, -C, -DRB1,
-DQB1, -DQA1, -DPB1, -DPA1) with mean fluorescence intensity (MFI) >3000 by solid
phase immunoassay

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 12/13/22. Questions regarding updates should be directed to the study team contact.

Other, Behavioral
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International Patient Education with Cultural Emphasis (I-PECE) (I-PECE)

Cross-Cultural Patient Education

Rayya Saadiq
All
18 years to 90 years old
This study is NOT accepting healthy volunteers
2021-305108-H01-RST
21-007307
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Inclusion Criteria:

  • Age 18- 90 years.
  • Able to communicate and participate in their own care.


Exclusion Criteria:

  • Speak a language that we do not have in-person translator at the clinic.
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EAA171, Optimizing Prolonged Treatment in Myeloma Using MRD Assessment (OPTIMUM)

Testing the Addition of Ixazomib to Lenalidomide in Patients With Evidence of Residual Multiple Myeloma, OPTIMUM Trial

Prashant Kapoor
All
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
2021-305127-P01-RST
21-006719
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Inclusion Criteria:

STEP 0: PRE-REGISTRATION

  • Patients must be previously diagnosed with multiple myeloma and be on lenalidomide maintenance with ≥ 10 mg daily dose for at least 10 months and no more than 15 months after an early autologous stem cell transplantation (SCT ≤ 12 months of diagnosis).
  • Patients should not be off lenalidomide maintenance therapy for more than 30 days prior to start of treatment on protocol.
  • Patients must be able to undergo a diagnostic bone marrow aspirate following registration to step 0.
    • NOTE: A bone marrow aspirate specimen must be submitted to Mayo Clinic Hematology Laboratory for central assessment of minimal residual disease (MRD) status to confirm patient's eligibility for step 1 randomization. Mayo Clinic will forward results ≤ within three (3) business days of receipt of the bone marrow specimen to the submitting institution.
  • Patients must not have primary refractory or progressive disease on a proteasome inhibitor-based regimen during induction therapy prior to stem cell transplant.
  • Patients must not be on other concurrent chemotherapy, or any ancillary therapy considered investigational.
    • NOTE: Bisphosphonates are considered to be supportive care rather than therapy and are allowed while on protocol treatment.
  • Patients must not have uncontrolled psychiatric illness or social situations that would limit compliance with study requirements.
  • Patients must not have another malignancy requiring treatment or have received treatment within 2 years before pre-registration or previously diagnosed with another malignancy and have any evidence of residual disease.
  • Patients with non-melanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.
  • Patients must have been able to maintain at least 10 mg dose of lenalidomide without growth factor support.
  • Patients must not have known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of ixazomib or lenalidomide including difficulty swallowing.
  • Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
  • Patients must not have known hepatitis B surface antigen-positive status or known or suspected active hepatitis C infection, but testing specifically for the trial is not required.

STEP 1 RANDOMIZATION

  • Patient must meet Step 0 eligibility criteria at the time of Step 1 randomization.
  • Patients must not be off lenalidomide maintenance therapy for more than 30 days prior to start of treatment on protocol.
  • Patients must have evidence of residual disease by central MRD testing or by presence of monoclonal protein in serum or urine.
  • Serum protein electrophoresis (SPEP), urine protein electrophoresis (UPEP), and serum free light chain (FLC) are required to be performed ≤ 28 days prior to randomization.
    • NOTE: UPEP (on a 24-hour collection) is required, no substitute method is acceptable. Urine must be followed monthly if the baseline urine M-spike is ≥ 200 mg/24 hour (hr).
    • Please note that if both serum and urine M-components are present, both must be followed in order to evaluate response.
    • Hemoglobin ≥ 8 g/dL (obtained ≤ 14 days prior to randomization).
    • Untransfused platelet count ≥ 75,000 cells/mm^3 (obtained ≤ 14 days prior to randomization).
    • Absolute neutrophil count ≥ 1000 cells/mm^3 (obtained ≤ 14 days prior to randomization).
    • Calculated creatinine clearance ≥ 30 mL/min (obtained ≤ 14 days prior to randomization).
    • Total bilirubin ≤ 1.5 times the upper limit of normal (obtained ≤ 14 days prior to randomization).
    • Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) and serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) ≤ 3 times the upper limit of normal (obtained ≤ 14 days prior to randomization).
    • Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2.
    • Patients must not have grade 2 or higher peripheral neuropathy or grade 1 peripheral neuropathy with pain per CTCAE.
    • Patients must not have uncontrolled intercurrent illness.
    • Patients must not have grade 2 or higher diarrhea per CTCAE in the absence of antidiarrheals.
    • Patients must not have been on systemic treatment, within 14 days before the first dose of ixazomib, with strong CYP3A inducers (rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital), or use of St. John's wort.
    • Patients must agree to register into the mandatory Risk Evaluation and Mitigation Strategies (REMS) program and be willing and able to comply with the requirements of REMS.
    • Women must not be pregnant due to potential harm to the fetus from ixazomib and lenalidomide. All females of childbearing potential (FCBP) must have a blood test or urine study with a sensitivity of at least 25 mIU/mL within 10-14 days prior to the first dose of lenalidomide and again within 24 hours prior to the first dose of lenalidomide. FCBP must also agree to ongoing pregnancy testing while on treatment. A female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria:
      • has achieved menarche at some point;
      • has not undergone a hysterectomy or bilateral oophorectomy; or
      • has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
  • Females of childbearing potential (FCBP) must either abstain from sexual intercourse for the duration of their participation in the study or agree to use TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME for
    • at least 28 days before starting study treatment;
    • while participating in the study;
    • during dose interruptions; and
    • for at least 90 days after the last dose of protocol treatment. Women must also agree to not breastfeed during this same time period. Men must agree to either abstain from sexual intercourse for the duration of their participation in the study or use a latex condom during sexual contact with a FCBP while participating in the study and for 90 days after the last dose of protocol treatment even if they have had a successful vasectomy. Men must also agree to abstain from donating sperm while on study treatment and for 28 days after the last dose of protocol treatment even if they have had a successful vasectomy. Both women and men must both agree to abstain from donating blood during study participation and for at least 28 days after the last dose of protocol treatment.
Drug, Other
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North American Prodromal Synucleinopathy Consortium for RBD, Stage 2 (NAPS2) (NAPS2)

North American Prodromal Synucleinopathy Consortium for RBD

Bradley Boeve
All
18 years and over
This study is NOT accepting healthy volunteers
2021-305130-P01-RST
21-006723
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Inclusion Criteria
•RBD Group:

  • All participants must have polysomnogram-confirmed RBD by ICSD-3 criteria [AASM 2014]. An EDF of a polysomnogram demonstrating RSWA must be available from NAPS1 or obtainable from elsewhere to verify this entry criterion.
  • Capable of providing informed consent at time of NAPS2 study enrollment, unless the participant previously enrolled in NAPS1:
    • For individuals previously enrolled in NAPS1 who developed cognitive decline and are no longer able to provide informed consent prior to enrollment in NAPS2, informed consent will be obtained from the legally authorized representative, and written assent obtained from the participant;
    • Individuals who enroll in NAPS2 will identify a proxy at initial enrollment. If a participant subsequently develops cognitive decline and is no longer able to provide informed consent for revised consent documents during follow-up visits, the proxy or legally authorized representative (depending on local regulations) will be asked to provide informed consent, and written assent obtained from the participant.
  • Age ≥ 18 years.

Exclusion Criteria
•RBD Group:

  • PD, dementia of any type, or MSA unless the individual was previously enrolled in NAPS1. Participants who phenoconvert during NAPS2 will be eligible to continue participation if they enrolled at a time when they were capable for providing informed consent.
    • Coexisting cognitive, motor, or autonomic symptoms are permitted in the RBD group provided that a diagnosis of dementia, PD, MSA, or any other overt neurodegenerative phenotype is not present;
    • The presence of “soft” cognitive, motor, autonomic, or other neurologic symptoms are appropriate for inclusion since 1) such features are common among RBD patients in the clinical setting, 2) such features are common in NAPS1participants,3) the NAPS2 program is designed to mimic recruitment of RBD patients who may be appropriate for participation in clinical trials, and 4) a primary goal of NAPS2 is to identify those at short-term risk of phenoconversion since clinical trials will focus on such RBD patient.
  • Narcolepsy-associated RBD.
  • RBD secondary to any known cause except prodromal synucleinopathy.
  • Participation in a clinical trial, except by specific permission by the Executive Committee.
  • In the opinion of the investigator, the participant has a clinically significant uncontrolled medical condition that would impede safe completion of the study protocol. 

Exclusions for Specific Procedures - RBD Group:

RBD participants will not be excluded from NAPS2 for the following exclusions; they will be excluded from undergoing the specific procedure(s).

  • Exclusions specific for MRI include any of the following:
    • metal implant or pacemaker;
    • Pregnancy;
    • Head/shoulder or body girth/weight unable to fit in the MRI scanner and coils;
    • Note that RBD participants who have claustrophobia or other issues completing MRI will not be excluded necessarily from MRI;
  • Exclusions specific for DaTscan SPECT include any of the following:
    • Pregnancy;
    • Head/shoulder or body girth/weight unable to fit in the SPECT scanner;
    • Note that RBD participants who have claustrophobia or other issues completing DaTscan will not be excluded necessarily from DaTscan;
    • Note that RBD participants who take concomitant medications that are potentially interfering for DaTscan as listed in the NI Manual of Procedures will not be excluded necessarily from DaTscan, but the specific medication(s) will be held if possible per site-specific protocols and at the discretion of the local Site Investigator. Any such medications will be noted in source documents at the time of scan.
    • History of an allergic reaction to iodine and iodine-containing products such as IV contrast dye (used for CT scans, IVPs, etc.). An allergy to shellfish is not exclusionary.
  • Exclusions specific for lumbar puncture include any of the following:
    • Diagnosis of a bleeding disorder;
    • Anticoagulant medication (coumadin, aspirin, etc.) is at the discretion of the local Site Investigator.  Site-specific procedures for lumbar puncture should be followed.

Inclusion Criteria
•Control Group:

  • Ability to provide written consent.
  • Age ≥ 18 years
  • Must meet age, sex, and race matching criteria per the DMS core recommendations for the site.
  • Must be willing and able to undergo all testing procedures, including neuroimaging and lumbar puncture.
  • Normal capacity to perform complex activities of daily living independently based on informant or physician report.

Exclusion Criteria
•Control Group:

  • History of dream enactment behavior to suggest RBD
  • Parkinsonism, MSA, dementia, or mild cognitive impairment
  • Active central nervous system, systemic, psychiatric condition or use of psychoactive medication that would adversely affect cognitive, neuropsychiatric, motor, or autonomic functioning:
    • Since the goal is to include typical normal persons, the Controls may include participants with adequately controlled medical and psychiatric conditions (based on physician determination and stratification in the RBD cohort);
    • This includes the use of stable doses of antidepressant medications, and their presence will be factored into any RBD vs Controls analyses.
  • Contraindications to complete MRI, including any of the following:
    •  
    • metal implant or pacemaker;
    • too claustrophobic to complete MRI scans;
    • previous issue completing an MRI;
    • Pregnancy;
    • Head/shoulder or body girth unable to fit in the MRI scanner and coils;
    • Body mass index > 35 kg/m^2 or weight > 300 lbs, due to neuroimaging scanner limits;
    • Participation in a clinical trial, except by specific permission by the Executive Committee;
    • In the opinion of the investigator, the participant has a clinically significant uncontrolled medical condition.
  • Contraindications to complete lumbar puncture:
    • Diagnosis of a bleeding disorder;
    • Anticoagulant medication (coumadin, aspirin, etc.) is at the discretion of the local Site Investigator.  Site-specific procedures for lumbar puncture should be followed.

Eligibility last updated 1/14/22. Questions regarding updates should be directed to the study team contact.

 

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A Minimal-Risk, Multi-Center, Prospective, Clinical Trial to Evaluate the PrevisEA Device for Predicting Gastrointestinal Impairment (Entac)

Clinical Trial to Evaluate the PrevisEA Device for Predicting Gastrointestinal Impairment

Kellie Mathis
All
18 years to 90 years old
This study is NOT accepting healthy volunteers
2021-305132-P01-RST
21-006729
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Inclusion Criteria:

  • ≥ 18 and ≤ 90 years of age.
  • Patient undergoing elective intestinal resection surgery including open, laparoscopic, robotic, or hand-assist technique for:
    • Segmental ileocolic resection with or without diversion;
    • Segmental colon resection with or without diversion;
    • Segmental coloproctectomy with or without diversion;
    • Low anterior resection with or without diversion;
    • Abdominoperineal resection;
    • Total abdominal colectomy with or without diversion;
    • Proctocolectomy with or without end ileostomy or diversion;
    • Closure of end colostomy (Hartmann’s reversal).


Exclusion Criteria:

  • Allergies to any of the device components (i.e., adhesive).
  • Inability to have prototype device applied to their abdominal wall due to disease conditions or surgical alterations (e.g., fistulas, stomas, drains, etc.).
  • Patients undergoing:
    • Small bowel resection without colonic resection;
    • Transanal proctectomy without transabdominal approach;
    • Perineal proctosigmoidectomy;
    • Closure of loop colostomy or ileostomy.
  • Patients with preoperative evidence of an anastomotic leak, deep wound infection, organ space infection, or urinary tract infection.
Colectomy, Digestive system
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PeRfOrmance and ACcuracy of an artifiCial intelligence Enhanced Smart watch Single lead ECG (PROCESS) (PROCESS)

Performance and Accuracy of an AI Enhanced Smart Watch Single lead ECG (PROCESS)

Itzhak Zachi Attia
All
18 years to 89 years old
This study is NOT accepting healthy volunteers
2021-305142-H01-RST
21-006770
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Inclusion Criteria:

  • Age ≥ 18 years and ≤ 89.
  • Able to give verbal consent.
  • Able to complete routine clinical 12 lead ECG tracing and single lead Apple Watch ECG tracing.


Exclusion Criteria:

  • Individuals < 18 and > 89 years of age.
  • Unable to given verbal consent.
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CAncer Survivor CArdiomyopathy DEtection (CASCADE) Pilot Study (CASCADE)

CAncer Survivor CArdiomyopathy DEtection (CASCADE) Pilot Study

Joerg Herrmann
All
18 years and over
This study is NOT accepting healthy volunteers
2021-305146-P01-RST
21-006790
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Inclusion Criteria:

  • ≥ 18 years of age at the time of enrollment.
  • Diagnosis of breast cancer, lymphoma, or sarcoma with either planned or at 1 year after completion of anthracycline therapy


Exclusion Criteria:
.

  • LVEF < 50% or prior confirmed history of cardiomyopathy, heart failure, persistent atrial fibrillation, left bundle branch block, or paced rhythm.
  • Individuals with pacemakers, defibrillators, or other implanted electronic devices.
  • Diagnosed with stage 4 cancer or metastatic disease.
  • inability/unwillingness of individual to give written informed consent.

Eligibility last updated 1/14/22. Questions regarding updates should be directed to the study team contact.

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Home-based Pulmonary Rehabilitation and Health Coaching in Fibrotic Interstitial Lung Disease

Home-based Pulmonary Rehabilitation and Health Coaching in Fibrotic Interstitial Lung Disease

Teng Moua
All
18 years to 95 years old
Phase 2
This study is NOT accepting healthy volunteers
2021-305150-H01-RST
21-006804
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Inclusion Criteria:

  • Diagnosis of IPF or other progressive fibrotic interstitial lung disease, with a minimum of > 10% fibrosis on computed tomography imaging.
  • Clinically meaningful breathlessness: modified Medical Research Council (mMRC) dyspnea score >1.


Exclusion Criteria:

  • Inability to walk (orthopedic/neurologic/cardiac limitation causing immobility).
  • Cognitive impairment or inability to understand and follow instructions.
  • Traditional PR completed within 3 months of study recruitment.
  • Hospice or end-of-life care at the time of screening.
  • Acute exacerbation at the time of screening.

Eligibility last updated 8/13/21. Questions regarding updates should be directed to the study team contact.

 

Behavioral
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Phase 1 Study of E6201 plus Dabrafenib for the Treatment of Central Nervous System (CNS) Metastases from BRAF V600- Mutated Metastatic Melanoma (E6201-01)

E6201 Plus Dabrafenib for the Treatment of Metastatic Melanoma Central Nervous System Metastases (CNS)

Svetomir Markovic
All
18 years and over
Phase 1
This study is NOT accepting healthy volunteers
2021-305152-P01-RST
22-000531
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Inclusion Criteria:

  • Males and females ≥ 18 years of age.
  • Histologically or cytologically confirmed BRAFV600-mutated melanoma.
  • Documented metastasis of the primary tumor to the CNS.
  • BRAF-mutation melanoma tumor status will be established prior to entry based on previous BRAF-gene analysis or MEK pathway mutation reports from a CLIA qualified  laboratory. If a report is not available, the mutation analysis will be performed at  Screening on archival tissue.
  • Other metastatic melanoma systemic disease allowed.
  • At least one measurable brain metastais, 0.5
    •3.0 cm, as assessed by MRI ≤ 3 weeks  prior to initiation of study treatment, provided neurological sequelae have resolved  completely and at least one measurable metastasis with documented disease progression  is present on MRI.
  • Prior stereotactic radiosurgery and/or excision of up to 3 brain metastases is allowed  > 3 weeks before initiation of study treatment, provided neurological sequelae have  resolved completely and at least one measurable metastasis with documented disease  progression is present on MRI.
  • One prior line of immunotherapy for metastatic disease is allowed, if ≥ 2 weeks has  elapsed between the end of therapy and initiation of study treatment.
  • Prior melanoma adjuvant immunotherapy is allowed, if ≥ 6 months has elapsed between  the end of therapy and initiation of study treatment.
  • Prior melanoma adjuvant BRAF/MEK inhibitor therapy is allowed, if ≥ 12 months has  elapsed between the end of therapy and initiation of study treatment.
  • Able to swallow and retain oral medication with no clinically significant  gastrointestinal abnormalities that may alter absorption, such as malabsorption syndrome or major resection of the stomach or bowels (Combination Safety Run-in and  Expansion Phases of the study only).
  • Asymptomatic or symptomatic CNS metastasis is allowed.
  • Stable dose of corticosteroids for CNS metastasis for ≥ 7 days allowed.
  • Patients with seizures due to CNS metastases must be controlled with stable anti-epileptic treatment for ≥ 14 days.
  • Bisphosphonates and/or denosumab are allowed.
  • Adequate performance status: Eastern Cooperative Oncology Group (ECOG) ≤ 2.
  • Life expectancy of ≥ 3 months. 
  • Adequate hematologic parameters without ongoing transfusional support:  
    • Hemoglobin (Hb) ≥ 9 g/dL;
    • Absolute neutrophil count (ANC) ≥ 1.0 x 10^9 cells/L;
    • Platelets ≥ 75 x 10^9 cells/L.
  • Adequate renal and hepatic function:  
    • Creatinine ≤ 1.5 x the upper limit of normal (ULN), or calculated creatinine clearance ≥ 50 mL/minute x 1.73 m^2;
    • Total bilirubin ≤ 2 times the upper limit of normal (ULN) unless due to Gilbert's disease;
    • ALT/AST ≤ 2.5 times ULN, or < 5 times ULN for subjects with liver metastases.
  • Negative serum pregnancy test within 14 days prior to the first dose of study therapy  for women of child-bearing potential (WCBP).
  • Sexually active WCBP and male subjects  must agree to use adequate methods to avoid pregnancy throughout the study and for 28  days after the completion of study treatment.
  • Ability to provide written informed consent.


Exclusion Criteria:

  • Urgent need of treatment to prevent acute neurologic deterioration, including urgent  neurosurgery or radiotherapy.
  • Symptoms of uncontrolled intracranial pressure.
  • Symptomatic or untreated spinal cord compression.
  • Prior treatment with any chemotherapeutic or investigational agent.
  • Prior treatment with any BRAF and/or MEK inhibitor for metastatic disease.
  • Prior treatment with > 1 line of immunotherapy for metastatic disease.
  • Serious cardiac condition within the last 6 months, such as uncontrolled arrhythmia, myocardial infarction, unstable angina or heart disease defined by the New York Heart  Association (NYHA) Class III or Class IV.
  • QT interval corrected for rate (QTc) > 480 msec for on the ECG obtained at Screening  using Fridericia method for QTc calculation.
  • Active infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or  hepatitis C virus (HCV) requiring systemic antiviral treatment within the last week  prior to study treatment.
  • Other active infection requiring IV antibiotic usage within the last week prior to  study treatment.
  • Any other medical intervention or other condition which, in the opinion of the Principal Investigator, could compromise adherence to study requirements or confound  the interpretation of study results.
  • Pregnant or breast-feeding.

Eligibility last updated 2/14/22. Questions regarding updates should be directed to the study team contact.

Drug, Administration of antineoplastic agent, Drug therapy
Brain metastasis, Cancer, Central nervous system disorder, Melanoma, Metastatic melanoma, Skin cancer
Cancer treatment, Central nervous system, Dabrafenib [USAN:INN], E-6201, Integumentary system, Malignant melanoma with BRAF V600E mutation, Medical Oncology, Nervous system, Targeted drug therapy, dabrafenib
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A Randomized, Double-Blind, Placebo-Controlled Study to Assess Safety, Tolerability, and Pharmacokinetics Following Multiple Doses of ABBV-CLS-7262 in Subjects with Amyotrophic Lateral Sclerosis Followed by an Active Treatment Extension (ABBV-CLS-7262)

A Study to Investigate the Safety and Pharmacokinetics of ABBV-CLS-7262 in Patients With Amyotrophic Lateral Sclerosis

Nathan Staff
All
18 years to 80 years old
Phase 1/2
This study is NOT accepting healthy volunteers
2021-305155-P01-RST
21-008728
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Inclusion Criteria:


- Must have an identified, reliable caregiver

- Confirmed diagnosis of Familial ALS or Sporadic ALS

- First ALS symptoms occurred ≤36 months before screening

- Able to swallow solids

- No known active COVID-19 infection at screening

- Vital capacity ≥50% predicted value (for sex, age, ethnic origin, and height) at
screening

- Subjects must be a) nai?ve to, or b) off riluzole (Rilutek), or c) on a stable dose
>30 days prior to Baseline visit to enter study

- Subjects must be a) nai?ve to, or b) off edaravone (Radicava), or c) have completed 2
treatment cycles prior to the Baseline visit.


Exclusion Criteria:


- History of dementia/severe cognitive problems at screening

- Use of riluzole (Rilutek®) if dose has NOT been stable for > 30 days prior to Baseline
visit

- History of clinically significant medical conditions (other than ALS) or any other
reason, including any physical, psychological, or psychiatric condition that, in the
opinion of the Investigator, would compromise the safety or interfere with the
subject's participation in the study, or would make the subject an unsuitable
candidate to receive study drug, or would put the subject at risk by participating in
the study.

- History of abnormal screening laboratory or imaging results that, in the opinion of
the Investigator, are indicative of any significant cardiac, endocrinologic,
hematologic, hepatic, immunologic, infectious, metabolic, urologic, pulmonary,
gastrointestinal, dermatologic, psychiatric, renal, neurologic, and/or other major
disease that would preclude administration of ABBV-CLS-7262.

- If female, is known to be pregnant, breastfeeding, considering becoming pregnant, or
donating/banking eggs during the study or within 30 days or >5 half-lives (whichever
is longer) after the last dose of study drug

- If male, plans to donate sperm or father a child during the study or within 30 days
after the last dose of study drug.

- Known to have received any investigational product within 30 days or 5 half-lives of
the drug (whichever is longer) prior to the first dose of study drug or is currently
enrolled in another clinical study.

- History of ABBV-CLS-7262 use prior to participation in this study

- Recent (within 6 months prior to Screening) history of drug or alcohol abuse

- Previous participation in a stem cell clinical study

- Current or anticipated use of diaphragmatic pacing during the study period

- Tracheostomy or use of non-invasive ventilatory support ≥22 hours a day

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 11/23/22. Questions regarding updates should be directed to the study team contact.

 

Drug, Other
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Mayo Clinic — Rochester, MN

Blinded Reference Set for Multicancer Early Detection Blood Tests

Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection

Amrit Singh
All
40 years to 75 years old
This study is NOT accepting healthy volunteers
2021-305158-P01-MAIJ
22-011457
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Inclusion Criteria:


- Participants with a cancer diagnosis: Documentation of disease:

- Histologic documentation: Histologically confirmed diagnosis of invasive cancer;

- Stage: Stage I-IV per American Joint Committee on Cancer (AJCC) 7th edition, with
the exception of patients with leukemia, lymphoma, and multiple myeloma;

- For leukemia: Type (chronic lymphocytic leukemia [CLL], chronic myeloid
leukemia [CML], acute lymphoblastic lymphoma [ALL], acute myeloid leukemia
[AML]);

- For lymphoma: Stage I-IV based on Ann Arbor staging;

- For multiple myeloma: Stage I, II, III based on Revised International
Staging System (RISS).

- One of the following tumor types:

- Colorectal;

- Bladder;

- Head and neck;

- Hepatobiliary;

- Lung;

- Lymphoma;

- Leukemia;

- Ovary *** For these specific cancer types only, patients may be enrolled
prior to histologic confirmation of malignancy. Sites are required to
contact the study chairs to review appropriateness for enrollment;

- Pancreas *** For these specific cancer types only, patients may be enrolled
prior to histologic confirmation of malignancy. Sites are required to
contact the study chairs to review appropriateness for enrollment;

- Multiple myeloma;

- Gastric, esophageal or gastroesophageal;

- Breast;

- Thyroid;

- Kidney;

- For these specific cancer types only, patients may be enrolled prior to
histologic confirmation of malignancy. Sites are required to contact
the study chairs to review appropriateness for enrollment;

- Endometrium;

- Prostate;

- Melanoma;

*** For these specific cancer types only, patients may be enrolled prior to
histologic confirmation of malignancy. Sites are required to contact the
study chairs to review appropriateness for enrollment;

- Sarcoma.

- Participants with a cancer diagnosis: No prior definitive systemic or local
anti-cancer intervention.

- Participants with a cancer diagnosis: Age ≥ 40 and ≤ 75.

- Participants with a cancer diagnosis: No known current pregnancy by self-report.

- Participants with a cancer diagnosis: No known or prior history of in situ or invasive
malignancy (excluding in situ non-melanoma skin cancers) other than the current cancer
diagnosis.

- Participants with a cancer diagnosis: Willingness to provide blood samples for
research use.

- Participants with a cancer diagnosis: Absence of medical contraindications to a
research blood draw volume of 60 mL.

- Participants with a cancer diagnosis: No history of organ transplantation.

- Participants with a cancer diagnosis: Ability to read and comprehend English or
Spanish.

* Eligibility is restricted to individuals who can comprehend and read English or
Spanish given that participation in the study will require the ability to read and
complete questionnaires that are available only in those two languages.

- Participants without a cancer diagnosis and without suspicion of cancer: Age ≥ 40 and
≤ 75.

- Participants without a cancer diagnosis and without suspicion of cancer: No known
current pregnancy by self-report.

- Participants without a cancer diagnosis and without suspicion of cancer: No known or
prior history of in situ or invasive malignancy (excluding in situ non-melanoma skin
cancers).

- Participants without a cancer diagnosis and without suspicion of cancer: Willingness
to provide blood samples for research use.

- Participants without a cancer diagnosis and without suspicion of cancer: Absence of
medical contraindications to a research blood draw volume of 60 mL.

- Participants without a cancer diagnosis and without suspicion of cancer: No history of
organ transplantation.

- Participants without a cancer diagnosis and without suspicion of cancer: Ability to
read and comprehend English or Spanish.

* Eligibility is restricted to individuals who can comprehend and read English or
Spanish given that participation in the study will require the ability to read and
complete questionnaires that are available only in those two languages.

- Participants with a high suspicion of cancer: High suspicion of ovarian cancer,
pancreatic cancer, kidney cancer, or melanoma by clinical and/or radiological
assessment, with plans for histologic or cytologic confirmation within 28 days after
study blood draw.

* Examples of highly suspicious cases include: elevated CA125 and abnormal
transvaginal ultrasound, suspicious renal or pancreatic mass on imaging, suspicious
cutaneous lesion concerning for melanoma.

- Participants with a high suspicion of cancer: Central review of radiology reports
and/or clinical documentation conducted by study chairs.

- Participants with a high suspicion of cancer: Age ≥ 40 and ≤ 75.

- Participants with a high suspicion of cancer: No known current pregnancy by
self-report.

- Participants with a high suspicion of cancer: No known or prior history of in situ or
invasive malignancy (excluding in situ non-melanoma skin cancers) other than the
current cancer diagnosis.

- Participants with a high suspicion of cancer: Willingness to provide blood samples for
research use.

- Participants with a high suspicion of cancer: Absence of medical contraindications to
a research blood draw volume of 60 mL.

- Participants with a high suspicion of cancer: No history or organ transplantation.

- Participants with a high suspicion of cancer: Ability to read and comprehend English
or Spanish *.   Eligibility is restricted to individuals who can comprehend and read
English and Spanish given that participation in the study will require the ability to
read and complete questionnaires that are available only in those two languages.

Eligibility last updated 10/27/22. Questions regarding updates should be directed to the study team contact.

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Mayo Clinic Health System — Mankato, MN

Blinded Reference Set for Multicancer Early Detection Blood Tests

Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection

Mina Hanna
All
40 years to 75 years old
This study is NOT accepting healthy volunteers
2021-305158-P01-ALCL
22-011457
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria:


- Participants with a cancer diagnosis: Documentation of disease:

- Histologic documentation: Histologically confirmed diagnosis of invasive cancer;

- Stage: Stage I-IV per American Joint Committee on Cancer (AJCC) 7th edition, with
the exception of patients with leukemia, lymphoma, and multiple myeloma;

- For leukemia: Type (chronic lymphocytic leukemia [CLL], chronic myeloid
leukemia [CML], acute lymphoblastic lymphoma [ALL], acute myeloid leukemia
[AML]);

- For lymphoma: Stage I-IV based on Ann Arbor staging;

- For multiple myeloma: Stage I, II, III based on Revised International
Staging System (RISS).

- One of the following tumor types:

- Colorectal;

- Bladder;

- Head and neck;

- Hepatobiliary;

- Lung;

- Lymphoma;

- Leukemia;

- Ovary *** For these specific cancer types only, patients may be enrolled
prior to histologic confirmation of malignancy. Sites are required to
contact the study chairs to review appropriateness for enrollment;

- Pancreas *** For these specific cancer types only, patients may be enrolled
prior to histologic confirmation of malignancy. Sites are required to
contact the study chairs to review appropriateness for enrollment;

- Multiple myeloma;

- Gastric, esophageal or gastroesophageal;

- Breast;

- Thyroid;

- Kidney;

- For these specific cancer types only, patients may be enrolled prior to
histologic confirmation of malignancy. Sites are required to contact
the study chairs to review appropriateness for enrollment;

- Endometrium;

- Prostate;

- Melanoma;

*** For these specific cancer types only, patients may be enrolled prior to
histologic confirmation of malignancy. Sites are required to contact the
study chairs to review appropriateness for enrollment;

- Sarcoma.

- Participants with a cancer diagnosis: No prior definitive systemic or local
anti-cancer intervention.

- Participants with a cancer diagnosis: Age ≥ 40 and ≤ 75.

- Participants with a cancer diagnosis: No known current pregnancy by self-report.

- Participants with a cancer diagnosis: No known or prior history of in situ or invasive
malignancy (excluding in situ non-melanoma skin cancers) other than the current cancer
diagnosis.

- Participants with a cancer diagnosis: Willingness to provide blood samples for
research use.

- Participants with a cancer diagnosis: Absence of medical contraindications to a
research blood draw volume of 60 mL.

- Participants with a cancer diagnosis: No history of organ transplantation.

- Participants with a cancer diagnosis: Ability to read and comprehend English or
Spanish.

* Eligibility is restricted to individuals who can comprehend and read English or
Spanish given that participation in the study will require the ability to read and
complete questionnaires that are available only in those two languages.

- Participants without a cancer diagnosis and without suspicion of cancer: Age ≥ 40 and
≤ 75.

- Participants without a cancer diagnosis and without suspicion of cancer: No known
current pregnancy by self-report.

- Participants without a cancer diagnosis and without suspicion of cancer: No known or
prior history of in situ or invasive malignancy (excluding in situ non-melanoma skin
cancers).

- Participants without a cancer diagnosis and without suspicion of cancer: Willingness
to provide blood samples for research use.

- Participants without a cancer diagnosis and without suspicion of cancer: Absence of
medical contraindications to a research blood draw volume of 60 mL.

- Participants without a cancer diagnosis and without suspicion of cancer: No history of
organ transplantation.

- Participants without a cancer diagnosis and without suspicion of cancer: Ability to
read and comprehend English or Spanish.

* Eligibility is restricted to individuals who can comprehend and read English or
Spanish given that participation in the study will require the ability to read and
complete questionnaires that are available only in those two languages.

- Participants with a high suspicion of cancer: High suspicion of ovarian cancer,
pancreatic cancer, kidney cancer, or melanoma by clinical and/or radiological
assessment, with plans for histologic or cytologic confirmation within 28 days after
study blood draw.

* Examples of highly suspicious cases include: elevated CA125 and abnormal
transvaginal ultrasound, suspicious renal or pancreatic mass on imaging, suspicious
cutaneous lesion concerning for melanoma.

- Participants with a high suspicion of cancer: Central review of radiology reports
and/or clinical documentation conducted by study chairs.

- Participants with a high suspicion of cancer: Age ≥ 40 and ≤ 75.

- Participants with a high suspicion of cancer: No known current pregnancy by
self-report.

- Participants with a high suspicion of cancer: No known or prior history of in situ or
invasive malignancy (excluding in situ non-melanoma skin cancers) other than the
current cancer diagnosis.

- Participants with a high suspicion of cancer: Willingness to provide blood samples for
research use.

- Participants with a high suspicion of cancer: Absence of medical contraindications to
a research blood draw volume of 60 mL.

- Participants with a high suspicion of cancer: No history or organ transplantation.

- Participants with a high suspicion of cancer: Ability to read and comprehend English
or Spanish *.   Eligibility is restricted to individuals who can comprehend and read
English and Spanish given that participation in the study will require the ability to
read and complete questionnaires that are available only in those two languages.

Eligibility last updated 10/27/22. Questions regarding updates should be directed to the study team contact.

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Mayo Clinic Health System — Albert Lea, MN

Open Label Single Center Trial Evaluating the Efficacy and Safety of Diazepam in GAD65 Associated Epilepsy

Diazepam Trial in GAD65 Associated Epilepsy

Kelsey Smith
All
18 years and over
Not Applicable
This study is NOT accepting healthy volunteers
2021-305159-H01-RST
21-007195
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Inclusion Criteria:


- High-titer serum GAD65 positivity > 20 nmol/L High-titer serum GAD65 IgG
seropositivity titer >20 nmol/L and/or CSF GAD65 seropositivity titer > 0.02 nmol/L.

- Drug-resistant focal epilepsy, having failed 2 previous anti-seizure medications.

- Stable treatment for the 1 month prior to enrollment.

- Patients must be able to give informed consent or have an appropriate representative
available to do.


Exclusion Criteria:


- Alternative etiology for epilepsy.

- Already on another benzodiazepine.

- On a regularly scheduled opiate.

- Co-existing antibodies associated with seizures.

- Pregnancy or breast feeding.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 8/19/22. Questions regarding updates should be directed to the study team contact.

Drug
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Mayo Clinic — Rochester, MN

Stress Echo 2030: The Novel ABCDE-(FGLPR) Protocol to Define the Future of Imaging- Review (SE2030)

Stress Echo 2030

Patricia Pellikka
All
18 years and over
This study is NOT accepting healthy volunteers
2021-305178-H01-RST
21-006982
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Inclusion Criteria:

  • Age 18+.
  • Undergoing a clinically indicated stress echo, Capacity to consent.
  • Prior diagnosis of the following:
  • Coronary Artery Disease
    • Undergoing SE for one of the following indications:
      • For Assessment of chest pain or dyspnea;
      • For reassessment after an abnormal test or assessment of known CAD (previous acute coronary syndrome and/or previous myocardial revascularization, prior CAD by invasive or noninvasive coronary angiography);
      • For risk stratification prior to high risk non-cardiac vascular surgery (such as liver transplant or major non-cardiac vascular surgery) in patients with poor functional capacity (< 4 METS) and/or suspected cardiac symptoms, in presence of a revised cardiac risk index (Lee criteria)  ≥ 2 (high risk surgery;
      • CAD;
      • congestive heart failure;
      • cerebrovascular disease;
      • diabetes mellitus on insulin;
      • serum creatinine > 2mg/ml).
  • Diastolic Heart Failure
    • Preserved EF;
    • Heart Failure score 1-5.
  • Hypertrophic Cardiomyopathy
    • Phenocopies such as infiltrative/ storage disease (e.g., Fabry, amyloid) will be excluded.
  • Post Chest Radio/Chemotherapy.
  • Tetralogy of Fallot (TOF)
    • Repaired TOF, double-outlet right ventricle Fallot type, tetralogy of Fallot with pulmonary atresia;
    • At least 1 year post-surgical or percutaneous procedure
    • Height > 140 cm;
    • New York Heart Association class I or II.
  • Mitral Regurgitation
    • Resting moderate mitral regurgitation (effective regurgitant orifice 0.2-0.39 cm^2, and regurgitant volume 30-59 ml) of ischemic origin.
  • Valvular Heart Disease
    • Asymptomatic severe aortic stenosis;
    • Low-flow, low-gradient aortic stenosis with reduced ejection fraction;
    • Low-flow, low-gradient aortic stenosis with preserved ejection fraction;
    • Asymptomatic severe or symptomatic non-severe primary mitral insufficiency;
    • Asymptomatic severe or symptomatic non-severe aortic regurgitation;
    • Asymptomatic severe or symptomatic non-severe mitral stenosis;
    • Asymptomatic severe or symptomatic non-severe multivalvular disease;
    • Post heart valve procedures (prostheses and valvuloplasty).


Exclusion Criteria:
 

  • Under the age of 18.
  • Unable to consent.
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Mayo Clinic — Rochester, MN

ATHN 16: Safety of SEVENFACT for the Treatment of Bleeding Events in Patients with Hemophilia A or B with Inhibitors (ATHN 16)

SEVENFACT® for Bleeding Events in Hemophilia With Inhibitors

Rajiv Pruthi
All
12 years and over
Phase 4
This study is NOT accepting healthy volunteers
2021-305182-P01-RST
21-008012
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Inclusion Criteria:


1. Have a diagnosis of hemophilia A or B with inhibitors.

2. Be 12 years of age and older

3. Be capable of understanding and willing to comply with the conditions of the protocol
or have a legal guardian who is capable of understanding and complying with the
conditions of the protocol

4. Have read, understood, and documented written informed consent/assent

5. Be able to provide medical evidence through prior medical history of previous
inhibitor levels

6. Be willing and able to use the ATHN mobile application or a paper diary to document
BEs and medication usage


Exclusion Criteria:


1. Have a disorder of hemostasis in addition to Hemophilia A or B

2. Have a known or suspected intolerance or hypersensitivity to SEVENFACT® or its
ingredients

3. Have a known allergy or hypersensitivity to rabbits or rabbit proteins

4. Are receiving prophylactic treatment for bleeding with a drug or biologic that is not
approved for this use by the FDA

5. Have had implantation of an investigational medical device within the prior 6 months

6. Have received an investigational drug within 30 days of the baseline visit

7. Have an elective surgical procedure planned during the duration of their participation
in the study*

8. Have any life-threatening disease, or other disease or condition which, in the
investigator's judgment, could pose a potential hazard to the patient or interfere
with study participation or study outcome (e.g., a history of non responsiveness to
bypassing products or thromboembolic disease)

- Should a participant require an unplanned surgery, the participant will not be
withdrawn from the study unless the investigator deems it necessary. Instead, the
participant will receive standard of care treatment as determined by the
attending physician. If the participant is not withdrawn from the study, the
participant's participation in the study will be paused until the investigator
feels it is safe for them to continue.

 

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 9/21/22. Questions regarding updates should be directed to the study team contact.

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Mayo Clinic — Rochester, MN

Dual-plane ultrasound imaging during vascular access procedures

Dual-plane Ultrasound Imaging During Vascular Access Procedures

Robert Anderson
All
18 years to 85 years old
Not Applicable
This study is NOT accepting healthy volunteers
2021-305191-H01-RST
21-007039
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Inclusion Criteria:

  • Patient: Elective surgical patients requiring non-emergent ultrasound-guided radial arterial catheter placement.
  • Providers: Anesthesia providers to include trainees, certified registered nurse anesthetists (CRNA) and attending anesthesia providers.


Exclusion Criteria:

  • Patient
    • Age younger than 18 years or older than 85 years.
    • Pregnant.
    • Patients in a moribund state or palliative care only.
    • Vulnerable patients (i.e., Severe mental handicap, non-decisional).
    • History of peripheral arterial disease.
    • Placement of arterial catheter without ultrasound guidance.
  • Provider: Medical students or CRNA students.

Eligibility last updated 8/17/21.  Questions regarding updates should be directed to the study team contact.

 

 

Procedure/Surgery
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Mayo Clinic — Rochester, MN

Functional Magnetic Resonance Elastography of the Brain (fMRE of Brain)

Functional Magnetic Resonance Elastography of the Brain

John Huston
All
18 years to 99 years old
This study is NOT accepting healthy volunteers
2021-305195-H01-RST
21-007067
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Inclusion Criteria:

  • Subjects between the ages of 18 to 99 years.
  • Willing to undergo a 1 hour MRI examination.


Exclusion Criteria:

  • Subjects will be excluded if contraindications to MRI scanning are present, such as the presence of a cardiac pacemaker, intraocular or intracranial metallic object or other MRI incompatible devices, and claustrophobia.  
  • A Magnetic Resonance Imaging (MRI) Patient Screening form will be completed by the subject per clinical practice requirements.
  • Pregnant or nursing women are not eligible to participate.     

Eligibility last updated 11/9/21. Questions regarding updates should be directed to the study team contact.

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Mayo Clinic — Rochester, MN

Reliability of a Modified King Devick Balance Test in Hockey Players While Wearing Skates (KD)

Balance Test in Hockey Players While Wearing Skates

David Krause
All
14 years to 20 years old
This study is NOT accepting healthy volunteers
2021-305197-H01-RST
21-006997
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Inclusion Criteria:

  • Male and female participants.
  • Age 14-20 years old.
  • No diagnosed concussion within the past 3 months.
  • Participating in organized traveling, high school, or junior hockey. 


Exclusion Criteria:
 

  • Any medical restriction or injury that would limit the ability to perform a balance screen.
  • Diagnosed concussion within the past 3 months.
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Mayo Clinic — Rochester, MN

A Phase 2b, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Rodatristat Ethyl in Patients with Pulmonary Arterial Hypertension (ELEVATE 2)

A Study of Rodatristat Ethyl in Patients With Pulmonary Arterial Hypertension (ELEVATE 2)

Vidhu Anand
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
2021-305199-P01-RST
21-005388
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Inclusion Criteria:

  • Male and female patients must be at least 18 years of age at the time of signing the informed consent:
    • Male patients and female partners must agree to use contraception starting 4 weeks prior to the first dose of IP, during the treatment period, and for at least 100 days after the last dose of IP. Male patients must refrain from donating sperm during this period;
    • Female patients of childbearing potential must agree to use contraception starting at Screening, during the treatment period, and for at least 4 weeks after the last dose of IP.
  • Body mass index (BMI) ≥ 18 kg/m^2 and ≤ 40 kg/m^2.
  • Patients with symptomatic PAH belonging to one of the following 2018 Clinical Group 1 Sub-types:
    • Idiopathic PAH;
    • Heritable PAH;
    • Drug- or toxin- induced.
  • PAH associated with:
    • Connective tissue disease.
  • Congenital systemic to pulmonary shunt (atrial septal defect, ventricular septal defect, patent ductus arteriosus) repaired at least one year prior to Screening.
  • Human Immunodeficiency Virus (HIV) infection
    •if diagnosed with HIV, must have stable disease status defined as follows:
    • stable treatment with HIV medications for at least 8 weeks prior to Screening;
    • no active opportunistic infection during the Screening Period;
    • no hospitalizations due to HIV for at least 4 weeks prior to Screening.
  • WHO FC II or III.
  • Confirmed diagnosis of PAH and meet all the following hemodynamic criteria by means of a screening RHC completed prior to randomization:
    • mPAP of ≥ 20 mmHg;
    • PVR ≥ 350 dyne•sec/cm^5;
    • Pulmonary capillary wedge pressure (PCWP) or left ventricular end diastolic pressure (LVEDP) of ≤ 12 mmHg if PVR ≥ 400 and < 500 dyne•sec/cm^5, or PCWP/LVEDP ≤ 15 mmHg if PVR ≥ 500 dyne•sec/cm^5;
    • 6MWD of 100 to 550 meters at Screening.
  • Currently on a stable treatment regimen with one or more treatments approved for PAH. Stable therapy is defined as receiving the same medication(s) for ≥ 12 weeks prior to the screening RHC and at a stable dose level for each for ≥ 8 weeks prior to the  screening RHC. Any instances where doses of a medication have been missed prior to RHC must be discussed with the Medical Monitor prior to performing the RHC.
  • Meet all of the following criteria determined by pulmonary function tests completed no more than 24 weeks prior to Screening (performed with or without bronchodilation):
    • Forced expiratory volume in one second (FEV1) ≥ 60% of predicted normal; and
    • Total lung capacity (TLC) ≥ 70% of predicted normal or FVC ≥ 70% predicted if TLC is not available; For subjects with CTD associated PAH, if TLC is ≥ 60% of predicted but < 70% of predicted of if FVC ≥ 60% or predicted but < 70% of predicted, high resolution computed tomography [HRCT] obtained within 6 months of screening may be utilized to demonstrate limited interstitial lung disease.
  • If participating in an exercise program for pulmonary rehabilitation, the program must have been initiated ≥ 12 weeks prior to Screening, and patient must agree to maintain the current level of rehabilitation for the first 24 weeks of IP. If not participating in an exercise training program for pulmonary rehabilitation, must agree not to enroll in an exercise training program for pulmonary rehabilitation during the Screening Period and the first 24 weeks of IP.
  • Willing and able to give written informed consent and to comply with the requirements of the study for its duration. 


Exclusion Criteria:

  • Women of childbearing potential who are pregnant, planning to become pregnant, or lactating or female/male patients unwilling to use effective contraception.
  • WHO Pulmonary Hypertension (PH) Group 1 PAH associated with portal hypertension or schistosomiasis; PH due to left heart disease (WHO PH Group 2), lung diseases and/or hypoxia (WHO PH Group 3), chronic thromboembolic pulmonary hypertension (WHO PH Group 4), or PH with unclear multifactorial mechanisms (WHO PH Group 5).
  • PAH associated with significant venous or capillary involvement (PCWP > 15 mmHg), pulmonary capillary hemangiomatosis, portal hypertension, or unrepaired congenital heart defects (CHD)
  • Three or more of the following risk factors for left ventricular disease:
    • BMI > 30 kg/m^2;
    • Diagnosis of essential hypertension that is actively treated;
    • Diabetes mellitus;
    • History of significant coronary artery disease (e.g., chronic stable angina, history of coronary intervention within the last 3 months, or a stenosis > 70% at coronary angiography);
    • Atrial fibrillation;
    • Left atrial volume index > 41 mL/m^2.
  • Known genetic hypertrophic cardiomyopathy.
  • Known cardiac sarcoidosis or amyloidosis.
  • The patient has a history of, or currently has, a constrictive cardiomyopathy.
  • Known history of any LVEF < 40% by echocardiogram within 3 years of randomization (Note: a transient decline in LVEF below 40% that occurred and recovered more than 6 months before the start of Screening and was associated with an acute intercurrent condition [e.g., atrial fibrillation] is allowed).
  • Hemodynamically significant valvular heart disease as determined by the Investigator, including:
    • greater than mild aortic and/or mitral stenosis; and/or
    • severe mitral and/or aortic regurgitation (> Grade 3).
  • Severe arthritis, musculoskeletal problems, or morbid obesity that, in the opinion of the Investigator, is the cause of the patient’s functional limitation and would affect the patient’s ability to perform or complete the 6MWT.
  • Planned major surgery within the next 3 months, including lung transplantation, major abdominal or major intestinal surgery
  • End stage renal disease defined as receiving peritoneal dialysis, hemodialysis, or status after renal transplantation; or severe liver disease defined as Child-Pugh Class C, with or without cirrhosis
  • Known congenital long QT syndrome (LQTS) or known family history of LQTS
  • Depression that is currently rated as severe (defined as a score of ≥ 16 on the QIDS-C and/or Hospital Anxiety and Depression Scale [HADS] Depression and/or Anxiety score ≥ 15), recent suicidal behavior (either preparatory acts/behavior, aborted attempt, interrupted attempt, or actual attempt in the past 3 months per the Screening Columbia Suicide Severity Rating Scale [C-SSRS], or active suicidal ideation with intent to act (defined as C-SSRS category score of 4 or 5 in the past month).
  • Patients with (during Screening):
    • Severe hypertension (SBP > 180 mmHg and/or Diastolic Blood Pressure [DBP] > 110 mmHg), and patients with severe hypotension (SBP < 90 mmHg and/or DBP < 50 mmHg);
    • Hypertension or hypotension considered not controlled in line with clinical standards.
  • Clinically significant electrolyte abnormality (e.g., hypokalemia, hypomagnesemia, or hypocalcemia) in the judgement of the Investigator.
  • Current or prior history within the last 5 years of neoplasm (except for treated basal cell or squamous small cell carcinoma of the skin with no evidence of recurrence)
  • Any concurrent clinically significant medical condition/disorder which in the Investigator’s opinion would interfere with the patient’s ability to comply with or complete the study or could affect the interpretation of the efficacy and safety variables.
  • Use of any of the following medications or supplements within 30 days prior to Screening: 
    • Monoamine oxidase inhibitors (MAOIs);
    • Hydroxytryptophan (5-HTP) or L-tryptophan;
    • Telotristat ethyl.
  • Patients currently taking one or more drugs known to prolong the QT interval and which are clearly associated with a known risk of Torsades de Pointe.
  • Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m^2 at Screening as determined by central laboratory.
  • 12-Lead electrocardiogram (ECG) results at Screening demonstrating QTcF interval > 450 ms for males or > 470 ms for females.
  • Elevated alanine transaminase (ALT), aspartate transaminase (AST)), or total bilirubin (TBL) > 2 x upper limit of normal (ULN).
  • Any ECG or clinical laboratory abnormality which precludes safe participation in the study in the opinion of the Investigator.
  • History of active substance abuse disorder (including alcohol) within the past 2 years which, in the option of the Investigator, would limit the ability of the patient to provide adequate informed consent or to comply with study requirements.
  • Use of any investigational drug within 30 days or 5 half-lives (whichever is longer) prior to Screening, or 90 days if an investigational drug for PAH, unless local health authority guidelines mandate a longer period, or in consultation with the medical monitor, will not interfere with the safety or efficacy of the study.
  • Any history of hypersensitivity to rodatristat ethyl, any of its components, or any components in the placebo preparation (refer to Rodatristat Ethyl IB, 2021).
  • Patient is deprived of their liberty by a judicial or administrative decision, or is receiving psychiatric care, and is admitted to a health or social institution.
  • Patient is subject to legal protection or is unable to express consent.

Eligibility last updated 5/9/22.  Questions regarding updates should be directed to the study team contact.

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LuMIERE: A Phase 1/2, Multicenter, Open-label, Non-randomized Study to Investigate Safety and Tolerability, Pharmacokinetics, Dosimetry, and Preliminary Activity of 177Lu-FAP-2286 in Patients with an Advanced Solid Tumor (LuMIERE)

A Study of 177Lu-FAP-2286 in Advanced Solid Tumors (LuMIERE)

Ajit Goenka
All
18 years and over
Phase 1/2
This study is NOT accepting healthy volunteers
2021-305200-P01-RST
21-007085
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Inclusion Criteria:


- Be ≥ 18 years of age at the time the ICF is signed.

- Consent to submission of archival tumor tissue, if available.

- Adequate bone marrow, hepatic, and renal function.

- ECOG performance status of 0 or 1.

- Life expectancy of at least 6 months.

- Measurable disease per RECIST v1.1.

Phase 1 only:

? Patients must have an advanced/metastatic solid tumor that is refractory to or has
progressed following prior treatment and has no satisfactory alternative treatment options.

Patient enrolled in Phase 2 will have one of several specific tumor types with advanced or
recurrent or metastatic disease following prior therapy.


Exclusion Criteria:


- Active second malignancy that may interfere with the safety or efficacy assessments of
this study

- Symptomatic and/or untreated central nervous system (CNS) metastases or leptomeningeal
disease or with primary tumor of CNS origin. Patients must be clinically stable for at
least 4 weeks without steroid treatment

- Received anticancer treatment ≤ 14 days prior to receiving study treatment (≤ 28 days
prior in case of checkpoint inhibitor or other antibody therapies)

- Received prior radiopharmaceutical therapy or radioembolization, or prior extensive
external beam radiation therapy (EBRT) to bone marrow or any prior EBRT to kidney, or
received any EBRT within 2 weeks prior to administration of study treatment

- Ongoing adverse effects from anticancer treatment > Grade 1, with the exception of
alopecia

- Known incompatibility with contrast media for CT or PET scans. Infection requiring
systemic antibiotics within 2 weeks prior to administration of study treatment

- Impaired cardiac function or clinically significant cardiac disease

- Severe urinary incontinence, voiding dysfunction, or urinary obstruction

- Minor surgery ≤ 5 days, or major surgery ≤ 21 days, prior to administration of study
treatment.

- Any other condition that may increase the risk associated with study participation or
interfere with its interpretation.

- Refusal to use highly effective method of contraception, as applicable

- Pregnant or breastfeeding

- Any other condition that may increase the risk associated with study participation or
interfere with its interpretation.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 9/20/22. Questions regarding updates should be directed to the study team contact.

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A Phase 1/1b Study to Evaluate the Safety and Tolerability of AB308 in Combination With AB122 in Participants With Advanced Malignancies

A Study to Evaluate AB308 in Combination With AB122 in Participants With Advanced Malignancies

Thanh Ho
All
18 years and over
Phase 1
This study is NOT accepting healthy volunteers
2021-305203-P01-RST
21-007097
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Inclusion Criteria:


- Capable of giving signed informed consent, which includes compliance with the
requirements and restrictions listed in the informed consent form (ICF) and in this
protocol.

- Male or female participants ≥ 18 years of age (or age ≥ regionally approved age of
consent for participation in investigational clinical studies) at the time of signing
the informed consent.

- Contraceptive use by men and women should be consistent with local regulations
regarding the methods of contraception for those participating in clinical studies.

- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1

- Adequate organ and marrow function


Exclusion Criteria:


- History of trauma or major surgery within 28 days prior to the first dose of study
treatment.

- Prior treatment with an anti-TIGIT antibody.

- Any active or prior autoimmune disease that required treatment within 3 years of the
first dose of study treatment.

- Prior chemotherapy, targeted small-molecule therapy, immunotherapy, or biologic
agents, or use of other investigational drugs within 28 days before first dose of
study treatment.

- Discontinued prior immunotherapy for immune related adverse events with a high
severity.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 12/15/22. Questions regarding updates should be directed to the study team contact.

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Enhancing Facial Nerve Neuroprotection and Regeneration Through Omega-3 Supplementation Following Vestibular Schwannoma Resection (VS)

Enhancing Facial Nerve Neuroprotection and Regeneration Through Omega-3 Supplementation Following Vestibular Schwannoma Resection

Michael Link
All
18 years and over
ERROR
This study is NOT accepting healthy volunteers
2021-305208-H01-RST
21-007120
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Inclusion Criteria:

  • All patients 18 of age or greater.
  • VS on final pathology report.
  • Surgical intervention (RS, MF, TL, other).
  • Primary and revision cases included, including prior radiation.

Exclusion Criteria;

  • History of liver disease or abnormal liver function tests.
  • Diabetic patients with specific contraindication to omega-3 supplementation.
  • History of bleeding disorder, or recommended use of anticoagulation (not including anti-platelets or NSAIDs) during the treatment period.
  • Age less than 18 years.
  • Neurofibromatosis 1 or 2, or schwanomatosis disorders.
  • Non-VS pathology.
  • Patients already taking fish oil/omega-3 supplementation.
Dietary Supplement, Other
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Assessing Renal Health in Patients with Chronic Liver Disease with Multiparametric Hepatorenal MRE/MRI (Hepatorenogram) (Magnetic Resonance Elastography (MRE))

Liver and Kidney Magnetic Resonance Elastography Study

Meng Yin
All
18 years and over
This study is NOT accepting healthy volunteers
2021-305211-H01-RST
21-006654
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Inclusion Criteria:

  • Primary liver diseases.
  • Diagnosis of suspected kidney function insufficient with laboratory test.
  • Age ≥ 18 years.


Exclusion Criteria:
 

  • Patients with kidney congenital diseases, such as renal agenesis, hypoplasia, horseshoe kidney, abnormal location kidney, etc.
  • Patients with transplant kidney.
  • Patients with HIV infection (lower immune activity).
  • History of liver transplantation or hepatic resection.
  • Absolute contraindications to MRI including pacemaker, AICD device, cochlear implant, VP shunt, aneurysm clip, a deep brain stimulator, and severe claustrophobia.
  • Women who are pregnant or breastfeeding.
  • Any severe medical condition that, in the opinion of the Principal Investigator, would serve as exclusion criteria for study enrollment.
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Burnout Reduction and Engagement App-based Trial of Headspace (BREATHE): A Randomized Clinical Trial (BREATHE)

Burnout Reduction and Engagement App-based Trial of Headspace (BREATHE): A Randomized Clinical Trial

Candace Granberg
All
21 years and over
Not Applicable
This study is NOT accepting healthy volunteers
2021-305218-H01-RST
21-007153
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Inclusion Criteria:

  • Being a health-professional at the Urology Department of Mayo Clinic, RST
  • Sign the informed consent and agreed to share data from the app to the research team.
  • *(Participants can withdraw a specific category of data directly from their smartphone) ** (patients who decline enrollment will be invited to take surveys coinciding with trial surveys).


Exclusion Criteria:

  • Using an alternate app designed with the same purpose at the beginning, part and/or entire duration of the study.
  • Not provide any data despite being included in the study​​​​​​​
Other
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Starstim: Safety and Therapeutic Measures of Transcranial Cathodal Direct Current Stimulation (TDCS) in Patients with Refractor Focal Epilepsy (Starstim)

Pivotal-Safety and Therapeutic Measures of tDCS in Patients With Refractory Focal Epilepsy

Brian Lundstrom
All
9 years and over
Not Applicable, Pivotal
This study is NOT accepting healthy volunteers
2021-305228-P01-RST
21-008120
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Inclusion Criteria:


1. 9 years old or older

2. Diagnosis of epilepsy with focal seizures with or without focal to bilateral tonic
clonic seizures (International League Against Epilepsy classification). Diagnosis
established by both clinical history and an electroencephalogram (EEG) consistent with
focal seizures. Note: A normal interictal EEG is consistent with focal seizures if
other data is adequate to provide localization.

3. Epilepsy is refractory to treatment, defined as: failure to achieve adequate seizure
control despite demonstrated compliance, according to medical records, on at least two
(2) FDA-approved ASDs at a daily dose considered therapeutic for the patient's
demographic according to package labeling, within approximately the last 3 years.

4. Seizure frequency >= 3 per month over the past year.

5. Currently on at least 1 ASD, with no changes in antiepileptic drug doses in the 3
weeks prior to baseline visit in the study and no planned dose changes during the
trial. Changes after baseline visit are permitted only if clinically necessary.

6. An MRI scan of the brain using 1.5 Tesla magnet, or greater, with T1, T2, and FLAIR
sequences, performed within the past 3 years and more recently than any craniotomy or
skull burr hole procedure.

7. Seizure focus that allows design of an appropriate stimulation montage Note: Seizure
focus can be identified within a lobe, or 2 adjacent lobes. Identification of the
border of the seizure focus can be approximate (+/- 2 gyri).

8. Available seizure history and supporting data

9. All female study subjects of child-bearing age are required to have a pregnancy test.
Additionally, all females of childbearing potential will be required to use an
effective method of birth control (defined as having a documented failure rate of ≤1%;
for women using enzyme-inducing ASDs hormonal contraceptives will not be considered as
effective).

10. Written informed consent obtained from study subject or subject's legal representative
and ability for study subject to comply with the requirements of the study.

11. Assent from pediatric subjects when appropriate.


Exclusion Criteria:


1. Presence of a condition or abnormality that in the opinion of the Investigator would
compromise the safety of the subject or the integrity of the data.

2. Evidence for more than one seizure focus. (NOTE: For this study, a seizure focus is
defined as a cortical region confined to one hemisphere and either one lobe or on a
junction of two adjacent lobes from which seizures arise, as documented by scalp or
intracranial EEG, that is either supported or not refuted by MRI, and either supported
or not refuted by clinical semiology). If the interictal EEG is normal, a seizure
focus may be identified by the combination of structural findings on MRI and clinical
signs/symptoms associated with the subject's seizures.

3. Seizure focus is one of: interhemispheric, cingulate, or orbitofrontal

4. Seizure focus is hemispheric or poorly defined

5. History of psychogenic non-epileptic seizures in past 2 years, or physiologic
nonepileptic seizures and non-epileptogenic events, including suspicion for or a
significant history of syncope, and any non-epileptic events must be clearly
differentiable from subject's focal seizures based on previously recorded video EEG
showing distinct clinical and electrographic features of the subject's PNES compared
to their epileptic seizures.

6. Seizures of generalized onset

7. Status epilepticus in the last 12 months

8. Presence of any disease, medical condition or physical condition that, in the opinion
of the Investigator, may compromise interfere, limit, affect or reduce the subject's
ability to complete a study of 24 weeks duration.

9. Presence of any disease, medical condition or physical condition that, in the opinion
of the Investigator, may adversely impact the safety of the subject or the integrity
of the data.

10. Damaged skin on scalp that may interfere with tDCS stimulation.

11. Pregnant, or unwilling to practice birth control during participation in the study.

12. Nursing mothers.

13. Any cranial metal implants (excluding ?1 mm thick epicranial titanium skull plates and
dental fillings) or medical devices (i.e. cardiac pacemaker, deep brain stimulator,
medication infusion pump, cochlear implant, vagus nerve stimulator).

14. Previous surgeries opening the skull leaving skull defects capable of allowing the
insertion of a cylinder with a radius greater or equal to 5 mm.

15. A history of addiction to, dependence on, abuse of, misuse of, distribution of, or use
of any illicit substance.

 

Eligibility last updated 7/1/22]. Questions regarding updates should be directed to the study team contact.

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A Prospective Registry for the Study of Outcomes and Predictors in Pouchitis and Pouch-Related Disorders (PROP-RD)

PROP-RD: A Prospective Registry for Pouch-Related Disorders

Laura Raffals
All
18 years and over
This study is NOT accepting healthy volunteers
2021-305251-P01-RST
21-007286
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Inclusion Criteria:

  • Patients with pouch-related conditions.
  • Chronic antibiotic refractory pouchitis (CARP).
  • Crohn’s disease (CD) of the pouch.


Exclusion Criteria:

  • None.

 

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A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of NBI-921352 as Adjunctive Therapy in Subjects with SCN8A Developmental and Epileptic Encephalopathy Syndrome (SCN8A-DEE) (SCN8A-DEE)

Study to Evaluate NBI-921352 as Adjunctive Therapy in Subjects With SCN8A Developmental and Epileptic Encephalopathy Syndrome (SCN8A-DEE)

Lily Wong-Kisiel
All
2 years to 21 years old
Phase 2
This study is NOT accepting healthy volunteers
2021-305257-P01-RST
21-009966
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Inclusion Criteria:

  • Written or oral pediatric assent from the subject if deemed capable of providing assent, and written informed consent from the subject’s parent(s) or legal guardian(s) for subjects < 18 years of age and for subjects ≥ 18 years of age who are not capable of providing consent in accordance with the governing Independent Ethics Committees (IEC)/Institutional Review Boards (IRB) and according to local laws and regulations. Subjects who are ≥ 18 years of age and capable of providing consent should sign an Informed Consent Form (ICF). Informed consent/assent may be done remotely, if allowed and remote consenting procedures are in place.
  • Be a male or female 2 to 21 years of age, inclusive.
  • Have a diagnosis of SCN8A-DEE supported by both clinical and genetic findings outlined as follows:
  • Clinical findings
    •required:
    • Seizure onset prior to 18 months of age;
    • Developmental delay which may have occurred either prior to or with onset of seizures or after.
  • Supportive (not required):
    • Multiple seizure types which include focal seizures (including focal to bilateral tonic-clonic), tonic-clonic seizures, epileptic/infantile spasms, tonic seizures;
    • History or ongoing motor abnormalities including hypotonia, dystonia, choreoathetosis, ataxia, spasticity, hyperekplexia;
    • Episodes of convulsive and nonconvulsive status epilepticus;
    • Beneficial response to sodium channel blockers such as phenytoin, valproate, carbamazepine, lacosamide, lamotrigine, rufinamide, and oxcarbazepine.
  • Genetic findings (both required):
    • Pathological gain of function (GOF) mutation in SCN8A defined as either a previously identified GOF mutation or a presumed pathological GOF mutation. Presumed pathological GOF mutations must be either a missense mutation that is not seen in either parent (de novo) OR a mutation which leads to a hyperfunctioning channel in in vitro function tests. Presumed pathological GOF mutations must not be nonsense mutations or other mutations likely to lead to a truncated protein;
    • No other pathogenic mutation in an additional gene that is known to cause epilepsy and is more likely to cause the epilepsy experienced by the subject.  

Genetic findings required for SCN8A-DEE diagnosis may be based on genetic testing performed previously. The genetic mutation in the subject’s SCN8A gene (b[i]) and the absence of other pathogenic mutations that are more likely to cause the epilepsy experienced by the subject (b[ii]) must be confirmed at screening as part of the comprehensive epilepsy panel genotyping.

  • Have SCN8A-DEE diagnosis confirmed by the DCP.
  • In the 90 days before screening, have a history of on average at least 4 countable motor seizures (defined as GTCS, tonic, atonic or FOS with noticeable motor component) per month.
  • Have on average at least 1 countable motor seizure (defined as GTCS, tonic, atonic or FOS with noticeable motor component) per week (4 per 28-day period) and not be seizure-free for more than 20 consecutive days per 28-day period during the baseline period.
  • Have at least 4 weeks of reliably and consistently completed baseline seizure diary data.
  • Being treated with at least 1 other ASM, but no more than 4 ASMs. Epidiolex®/Epidyolex® will be considered an ASM. The dose should be stable for at least 5 half-lives at screening. Vagus nerve stimulator (VNS) and ketogenic diet are not counted as ASMs.
  • Have failed to achieve seizure freedom with at least 2 ASMs.
  • The subject, if using a VNS, must have had the VNS placed at least 3 months prior to screening with stable settings for ≥ 30 days before screening; settings must remain stable throughout the duration of the study.
  • The subject, if on a ketogenic diet, must have started the ketogenic diet at least 30 days prior to screening; diet must be stable, and continue through the duration of the study.
  • Must be using a nocturnal alerting system or practice consistent with standards of care at the time of screening and continue to use this for the duration of the study. Acceptable nocturnal alerting systems or practices include but are not limited to:
    • Parent/caregiver sleeps in the same room as subject;
    • Video- and/or acoustic-based monitoring (e.g., use of baby monitor);
    • Device intended as a seizure alert system (e.g., bracelet devices).
  • Must have an adequate rescue medication regimen per the investigator’s judgment in place at the time of screening and for the duration of the study.
  • Female subjects of childbearing potential must agree to use contraception consistently from screening until the final study visit or 30 days after the last dose of study treatment, whichever is longer.

A female subject of childbearing potential is defined as a female capable of becoming pregnant, which includes subjects who have had their first menstrual cycle (ie, menarche) and are not surgically sterile (ie, bilateral oophorectomy, hysterectomy or bilateral tubal ligation for at least 3 months prior to screening). A male subject of childbearing potential is defined as a subject who has reached spermarche and has not been vasectomized for at least 3 months prior to screening.

  • Highly effective methods of contraception are required for female subjects of childbearing potential:
    • Intrauterine device (IUD) or intrauterine hormone-releasing system (IUS);
    • Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (which may be oral, intravaginal, or transdermal) initiated and used in accordance with medical direction for at least 3 months prior to screening;
    • Progestogen-only hormonal contraception associated with inhibition of ovulation, which may be oral, injected, or implanted initiated and used in accordance with medical direction for at least 3 months prior to screening;
    • Bilateral tubal ligation;
    • Total abstinence from sexual intercourse (periodic abstinence is not acceptable);
    • Sexual partner(s) who had been vasectomized at least 3 months prior to screening with medically confirmed successful procedure;

Male subjects must agree to use effective barrier contraception consistently from screening until 30 days after the last dose of study treatment. The acceptable method of contraception for male subjects is condom with spermicide (cream, spray, foam, gel, suppository, or polymer film).

  • Have a body weight of at least 10 kg.
  • Be able to carry out all the appropriate assessments and take the study treatment with the help of the parent/caregiver in the opinion of the investigator.
  • Te subject’s parent/caregiver is able to accurately identify seizure types, especially countable motor seizures (defined as GTCS, tonic, atonic or FOS with noticeable motor component) and is able to complete seizure diary.


Exclusion Criteria:

  • Have previously been enrolled in this study and received blinded treatment.
  • Have participated in an interventional clinical trial <30 days prior to screening.
  • Have symptoms that would be more consistent with another epilepsy disorder such as Dravet syndrome (e.g., fever-induced episodes of status epilepticus, frequent myoclonic seizures, worsening on sodium channel blockers).
  • Are currently receiving cannabinoids or medical marijuana except Epidiolex/Epidyolex, unless approved by the Sponsor.
  • Are currently taking systemic steroids (excluding inhaled medication for asthma treatments) such as adrenocorticotropin hormone (ACTH), high dose prednisolone for epileptic spasms.
  • If subject has received these medications in the past, must be off these medications for at least 3 months prior to the screening visit and these drugs may not be initiated during the duration of the study. Intermittent steroids to treat nonepilepsy related diseases (such as allergies or dermatological conditions) are not exclusionary.
  • Are taking strong CYP3A4 inhibitor (e.g., ketoconazole, erythromycin, ritonavir) or inducer (e.g., rifabutin, rifampin, St. John's Wort) other than concurrent ASMs.
  • Have a history of severe drug allergy or hypersensitivity to NBI-921352 or its excipients.
  • Have a previous exposure to NBI-921352.
  • Have any other disorder for which the treatment takes priority over treatment of SCN8A-DEE or is likely to interfere with study treatment or impair treatment compliance.
  • Have a history of moderate or severe head trauma or other neurological disorders or systemic medical diseases that are, in the investigator’s opinion, likely to affect nervous system functioning.
  • Have a clinically significant medical condition or chronic disease (including history of neurological, hepatic, renal, cardiovascular, gastrointestinal, significant malabsorption, hematologic, pulmonary, psychiatric, or endocrine disease) that in the opinion of the investigator would preclude the subject from participating in and completing the study or that could confound interpretation of study outcome.
  • Are taking or have received disallowed concomitant medication or it is anticipated that the subject will require treatment with at least one of the disallowed concomitant medications during the study.
  • Have clinically significant abnormal vital signs at the screening visit as determined by the investigator.
  • Have one or more clinical laboratory test values outside the reference range, based on blood samples taken at the screening visit, that are of potential risk to the subject’s safety as determined by the investigator, or have at the screening visit:
    • A serum creatine value > 1.5 times the upper limit of the reference range;
    • A total bilirubin value > 1.5 times the upper limit of the reference range;
    • A serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value > 2.5 times the upper limit of the reference range. For subjects on valproate, ALT or AST values up to 3 times the upper limit of the reference range are acceptable, if these values have remained stable over the past 3 months based on investigator judgement.
  • Have, at the screening visit, an ECG finding of a corrected QT interval using Fridericia’s formula (QTcF) > 450 msec or presence of any significant cardiac abnormality.
  • The subject or subject’s parent/caregiver, in the investigator’s opinion, is unlikely to comply with the protocol, including the requirement to travel to the study sites for study visits, or is unsuitable for any reason.
  • Have attempted suicide within the last year or are at significant risk of suicide (either in the opinion of the investigator or defined as a “yes” to suicidal ideation questions 4 or 5 or “yes” to suicidal behavior on the C-SSRS within the past 12-months).
  • Females who are pregnant or currently breastfeeding.
  • Have a history of a positive hepatitis A virus immunoglobulin M (HAV-IgM), hepatitis B surface antigen (HBsAg), or human immunodeficiency virus antibody (HIV-Ab) test results at screening. Subject with positive hepatitis C antibody (HCV-Ab) and confirmatory positive polymerase chain reaction (PCR) reflex test results at screening will be allowed to participate in the study provided that the subject is asymptomatic as assessed by the investigator and does not have exclusionary liver function test abnormalities (ALT, AST, and total bilirubin).
  • Have ingested grapefruit juice or grapefruit products within a 7-day period before Day -1.
Drug, Drug therapy
Encephalopathy, Epilepsy, Grand mal seizure, Seizure
NBI-921352, Nervous system, SCN8A-related epilepsy with encephalopathy
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A Phase 3, Double-Blind, Randomized, Vehicle-Controlled, Efficacy and Safety Study of Ruxolitinib Cream Followed by a Long-Term Safety Extension Period in Children (Ages≥ 2 Years to < 12 Years) With Atopic Dermatitis ((TRuE-AD3) (TRuE-AD3)

A Study to Assess the Efficacy and Safety of Ruxolitinib Cream in Children With Atopic Dermatitis (TRuE-AD3)

Megha Tollefson
All
2 years to 11 years old
Phase 3
This study is NOT accepting healthy volunteers
2021-305264-P01-RST
21-007324
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Inclusion Criteria:

  • Participants diagnosed with Atopic Dermatitis (AD) as defined by the Hanifin and Rajka criteria.
  • Participants with AD duration of at least 3 months (participant/parent/guardian may verbally report signs and symptoms of AD with onset at least 3 months prior).
  • Participants with IGA score of 2 to 3 at the screening and baseline visits.
  • Participants with % BSA (excluding scalp) of AD involvement of 3% to 20% at screening and baseline visits.
  • For children aged 6 years to < 12 years, baseline itch NRS score ≥ 4.
  • Participants/guardians who agree to discontinue all agents used by the participant to treat AD from the screening visit through the final safety follow-up visit.
  • Participants with at least 1 target lesion that measures at least 5 cm^2 at the screening and baseline visits. The target lesion must be representative of the participant's disease state but not located on the hands, feet, or genitalia.
  • Willingness to avoid pregnancy or fathering a child for the duration of study participation.


Exclusion Criteria:

  • An unstable course of AD (spontaneously improving or rapidly deteriorating) as determined by the investigator over the previous 4 weeks before the baseline visit. -Concurrent conditions and history of other diseases as follows:
    • Immunocompromised;
    • Chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before the baseline visit;
    • Active acute bacterial, fungal, or viral skin infection within 1 week before the baseline visit;
    • Any other concomitant skin disorder, pigmentation, or extensive scarring that in the opinion of the investigator may interfere with the evaluation of AD lesions or compromise participant safety;
    • Presence of AD lesions only on the hands or feet without prior history of involvement of other classic areas of involvement such as the face or the flexural folds;
    • Other types of eczema;
    • Chronic asthma requiring more than 880 µg of inhaled budesonide or equivalent high dose of other inhaled corticosteroids.
  • Any serious illness or medical, physical, or psychiatric condition(s) that, in the investigator's opinion, would interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.
  • Use of any of the following treatments within the indicated washout period before the baseline visit:
    • 5 half-lives or 12 weeks, whichever is longer – biologic agents (e.g., dupilumab);
    • 4 weeks – systemic corticosteroids or adrenocorticotropic hormone analogues, cyclosporin, methotrexate, azathioprine, or other systemic immuno-suppressive or immunomodulating agents (e.g., mycophenolate or tacrolimus);
    • 2 weeks – immunizations with live-attenuated vaccines; sedating antihistamines unless on a long-term stable regimen (nonsedating antihistamines are permitted).
    • Note: Live-attenuated vaccines are not recommended during the VC period. Note: COVID-19 vaccination is allowed;
    • 1 week – use of topical treatments for AD (other than bland emollients; e.g., Aveeno® creams, ointments, sprays, soap substitutes), such as topical antipruritics (e.g., doxepin cream), corticosteroids, calcineurin inhibitors, PDE4 inhibitors, coal tar (shampoo), topical antibiotics, or antibacterial cleansing body wash/soap.
    • Note: Diluted sodium hypochlorite "bleach" baths are allowed as long as they do not exceed 2 baths per week and their frequency remains the same throughout the study.
  • Participants who have previously received JAK inhibitors, systemic or topical.
  • Ultraviolet light therapy or prolonged exposure to natural or artificial sources of UV radiation (e.g., sunlight or tanning booth) within 2 weeks prior to the baseline visit and/or intention to have such exposure during the study, which is thought by the investigator to potentially impact the participant's AD.
  • Positive serology test results at screening for HIV antibody.
  • Current treatment or treatment within 30 days or 5 half-lives (whichever is longer) before the baseline visit with another investigational medication or current enrollment in another investigational drug protocol.
  • In the opinion of the investigator, unable or unlikely to comply with the administration schedule and study evaluations.
  • Employees of the sponsor or investigator or otherwise dependents of them.

Eligibility last updated 5/9/22. Questions regarding updates should be directed to the study team contact.

Drug
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Mayo Clinic — Rochester, MN

LOXO-BTK-20022, A Phase 3 Open-Label, Randomized Study of Fixed Duration Pirtobrutinib (LOXO-305) Plus Venetoclax and Rituximab Versus Venetoclax and Rituximab in Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (BRUIN CLL-322) (BRUIN CLL-322)

A Trial of Pirtobrutinib (LOXO-305) Plus Venetoclax and Rituximab (PVR) Versus Venetoclax and Rituximab (VR) in Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)

Yucai Wang
All
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
2021-305267-P01-RST
21-007472
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Inclusion Criteria:

  • Age 18 and older at time of enrollment.
  • Confirmed diagnosis of CLL/SLL requiring therapy per iwCLL 2018 criteria.
  • Previous treatment with at least one line of therapy that may include a covalent Bruton's tyrosine kinase (BTK) inhibitor.
  • Platelets ≥ 50 x 10⁹/liter (L), hemoglobin ≥ 8 grams/deciliter (g/dL) and absolute neutrophil count ≥ 1.0 x 10⁹/L.
  • Adequate organ function.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2.
  • Estimated creatinine clearance ≥ 30 milliliters per minute (mL/min).


Exclusion Criteria:

  • Known or suspected Richter's transformation at any time preceding enrollment.
  • Prior therapy with a non-covalent (reversible) BTK inhibitor.
  • Patients requiring therapeutic anticoagulation with warfarin or another Vitamin K antagonist.
  • Current treatment with strong cytochrome P450 (CYP) 3A4 (CYP3A4) inhibitors or inducers and/or strong P-glycoprotein (P-gp) inhibitors.
  • Prior therapy with venetoclax.
  • Central nervous system (CNS) involvement.
  • Active uncontrolled systemic bacterial, viral, fungal, or parasitic infection.
  • Known human immunodeficiency virus (HIV) infection, regardless of cluster of differentiation 4 (CD4) count.
  • Allogeneic stem cell transplantation (SCT) or chimeric antigen receptor (CAR)-T within 60 days.
  • Active hepatitis B or hepatitis C.
  • Known active cytomegalovirus (CMV) infection.
  • Uncontrolled immune thrombocytopenic purpura (ITP) or autoimmune hemolytic anemia (AIHA).
  • Significant cardiovascular disease.
  • Vaccination with a live vaccine within 28 days prior to randomization.
  • Patients with the following hypersensitivity:
    • Known hypersensitivity to any component or excipient of pirtobrutinib and venetoclax;
    • Prior significant hypersensitivity to rituximab;
    • Known allergy to allopurinol and inability to take uric acid lowering agent.
Drug, Behavioral
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Mayo Clinic — Rochester, MN

NEOD001-301 A Phase 3, Randomized, Multicenter, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Birtamimab Plus Standard of Care vs. Placebo Plus Standard of Care in Mayo Stage IV Subjects With Light Chain (AL) Amyloidosis (AFFIRM-AL)

A Study to Evaluate the Effectiveness and Safety of Birtamimab in Mayo Stage IV Patients With AL Amyloidosis

Morie Gertz
All
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
2021-305269-P01-RST
21-007322
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Key

Inclusion Criteria:


- Aged ≥18 years and legal age of consent according to local regulations

- Newly diagnosed and AL amyloidosis treatment-naïve with cardiac involvement

- Confirmed diagnosis of AL amyloidosis

- Confirmed Mayo Stage IV AL Amyloidosis as defined by NT-proBNP ≥1800 pg/mL and
Troponin-T >0.03 ng/mL and dFLC ≥18 mg/dL

- Planned first-line chemotherapy contains bortezomib administered subcutaneously
weekly.

Key
Exclusion Criteria:


- Non-AL amyloidosis.

- NT-proBNP >8500 pg/mL.

- Meets the International Myeloma Working Group (IMWG) definition of multiple myeloma

- Subject is eligible for and plans to undergo ASCT or organ transplant during the
study.

- Myocardial infarction, uncontrolled angina, severe uncontrolled ventricular
arrhythmias, or ECG evidence of acute ischemia, within 6 months prior to the Month
1-Day 1 Visit.

- Severe valvular stenosis (e.g., aortic or mitral stenosis with a valve area <1.0 cm2)
or severe congenital heart disease.

- ECG evidence of acute ischemia or active conduction system abnormalities

- Prior treatment with hematopoietic growth factors, transfusions of blood or blood
products within 1 week of Month 1-Day 1.

- Prior radiotherapy within 4 weeks of Month 1-Day 1.

- Prior treatment with plasma cell-directed chemotherapy, birtamimab, daratumumab, 11-
1F4, anti-serum amyloid P antibody, doxycycline for amyloid, or other investigational
treatment directed at amyloid .

- Waldenström's macroglobulinemia and/or immunoglobulin M monoclonal gammopathy

Eligibility last updated 6/21/22. Questions regarding updates should be directed to the study team contact.

 

Biologic/Vaccine, Other
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Mayo Clinic — Rochester, MN