Trial Title:
HLA-Mismatched Unrelated Donor Peripheral Blood Stem Cell Transplantation with Reduced Dose Post Transplantation Cyclophosphamide GvHD Prophylaxis
NCT ID:
NCT06001385
Condition:
Acute Lymphoblastic Leukemia
Acute Myeloid Leukemia
Acute Leukemia
Myelodysplastic Syndromes
Chronic Myeloid Leukemia
Chronic Lymphocytic Leukemia
Myeloproliferative Neoplasm
Lymphoma
Chronic Myelomonocytic Leukemia
Pro-Lymphocytic Leukemia
Myelofibrosis
Conditions: Official terms:
Lymphoma
Leukemia
Neoplasms
Leukemia, Myeloid
Preleukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myelomonocytic, Chronic
Leukemia, Myelomonocytic, Juvenile
Leukemia, Prolymphocytic
Myelodysplastic Syndromes
Myeloproliferative Disorders
Mycophenolic Acid
Cyclophosphamide
Melphalan
Busulfan
Fludarabine
Tacrolimus
Conditions: Keywords:
Lymphoma
Leukemia
Hematologic Diseases
Myelodysplastic Syndromes
Preleukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia , Lymphocytic, Chronic, B-Cell
Leukemia, Myeloid, Acute
Leukemia, Biphenotypic, Acute
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Disorders
Bone Marrow Diseases
Precancerous Conditions
Leukemia, Lymphoid
Leukemia, B-Cell
Leukemia, Myeloid
Cyclophosphamide
Mesna
Tacrolimus
Busulfan
Fludarabine
Total Body Irradiation
Melphalan
Mycophenolate mofetil
Reduced Dose Cyclophosphamide
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Hematopoietic Stem Cell Transplantation
Peripheral Blood Stem Cells
Unrelated Donors
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Busulfan
Description:
Given IV or PO pre-transplant as part of conditioning regimen
Arm group label:
Regimen A (MAC: Busulfan and Fludarabine, PBSC HCT; Reduce Dose PTCy
Arm group label:
Regimen C (RIC: Fludarabine and Busulfan; PBSCT HCT; Reduced Dose PTCy
Other name:
Busulfex®
Intervention type:
Drug
Intervention name:
Fludarabine
Description:
Given IV pre-transplant as part of conditioning regimen
Arm group label:
Regimen A (MAC: Busulfan and Fludarabine, PBSC HCT; Reduce Dose PTCy
Arm group label:
Regimen B (MAC: Fludarabine and TBI, PBSC HCT; Reduce Dose PTCy
Arm group label:
Regimen C (RIC: Fludarabine and Busulfan; PBSCT HCT; Reduced Dose PTCy
Arm group label:
Regimen D (RIC: Fludarabine and Melphalan; PBSCT HCT; Reduced Dose PTCy
Arm group label:
Regimen E (NMA: Fludarabine, Cyclophosphamide, and TBI; PBSCT HCT; Reduced Dose PTCy
Other name:
Fludara®
Intervention type:
Procedure
Intervention name:
PBSC Hematopoietic Stem Cell Transplantation (HSCT)
Description:
Peripheral blood stem cell graft is infused from a mismatched unrelated donor on Day 0
Arm group label:
Regimen A (MAC: Busulfan and Fludarabine, PBSC HCT; Reduce Dose PTCy
Arm group label:
Regimen B (MAC: Fludarabine and TBI, PBSC HCT; Reduce Dose PTCy
Arm group label:
Regimen C (RIC: Fludarabine and Busulfan; PBSCT HCT; Reduced Dose PTCy
Arm group label:
Regimen D (RIC: Fludarabine and Melphalan; PBSCT HCT; Reduced Dose PTCy
Arm group label:
Regimen E (NMA: Fludarabine, Cyclophosphamide, and TBI; PBSCT HCT; Reduced Dose PTCy
Other name:
PBSC HSCT
Other name:
PBSC HCT
Other name:
PBSC Transplantation
Other name:
PBSCT
Intervention type:
Drug
Intervention name:
Post-Transplant Cyclophosphamide
Description:
Cyclophosphamide (25mg/kg) is administered on Day 3 and Day 4 post-transplant as an IV
infusion over 1-2 hours.
First 20 subjects with a 4-6/8 HLA mismatched unrelated donor will receive an
intermediate dose of post-transplant cyclophosphamide of 37.5 mg/kg Day 3 and Day 4
post-transplant.
Arm group label:
Regimen A (MAC: Busulfan and Fludarabine, PBSC HCT; Reduce Dose PTCy
Arm group label:
Regimen B (MAC: Fludarabine and TBI, PBSC HCT; Reduce Dose PTCy
Arm group label:
Regimen C (RIC: Fludarabine and Busulfan; PBSCT HCT; Reduced Dose PTCy
Arm group label:
Regimen D (RIC: Fludarabine and Melphalan; PBSCT HCT; Reduced Dose PTCy
Arm group label:
Regimen E (NMA: Fludarabine, Cyclophosphamide, and TBI; PBSCT HCT; Reduced Dose PTCy
Other name:
Cytoxan®
Other name:
PTCy
Intervention type:
Drug
Intervention name:
Mesna
Description:
Mesna is given in divided doses IV 30 min pre- and at 3, 6, and 8 hours post
cyclophosphamide.
Arm group label:
Regimen E (NMA: Fludarabine, Cyclophosphamide, and TBI; PBSCT HCT; Reduced Dose PTCy
Other name:
Mesnex®
Intervention type:
Drug
Intervention name:
Tacrolimus
Description:
Tacrolimus is given at a dose of 0.05 mg/kg PO or an IV dose of 0.03 mg/kg of ideal body
weight (IBW) starting on Day +5 post-transplant with taper recommended at Day + 90 and
finished by Day +180.
Arm group label:
Regimen A (MAC: Busulfan and Fludarabine, PBSC HCT; Reduce Dose PTCy
Arm group label:
Regimen B (MAC: Fludarabine and TBI, PBSC HCT; Reduce Dose PTCy
Arm group label:
Regimen C (RIC: Fludarabine and Busulfan; PBSCT HCT; Reduced Dose PTCy
Arm group label:
Regimen D (RIC: Fludarabine and Melphalan; PBSCT HCT; Reduced Dose PTCy
Arm group label:
Regimen E (NMA: Fludarabine, Cyclophosphamide, and TBI; PBSCT HCT; Reduced Dose PTCy
Intervention type:
Drug
Intervention name:
Mycophenolate Mofetil
Description:
Mycophenolate mofetil (MMF) is given at a dose of 15 mg/kg three times daily IV or PO
from Day +5 to Day +35 post-transplant.
Arm group label:
Regimen A (MAC: Busulfan and Fludarabine, PBSC HCT; Reduce Dose PTCy
Arm group label:
Regimen B (MAC: Fludarabine and TBI, PBSC HCT; Reduce Dose PTCy
Arm group label:
Regimen C (RIC: Fludarabine and Busulfan; PBSCT HCT; Reduced Dose PTCy
Arm group label:
Regimen D (RIC: Fludarabine and Melphalan; PBSCT HCT; Reduced Dose PTCy
Arm group label:
Regimen E (NMA: Fludarabine, Cyclophosphamide, and TBI; PBSCT HCT; Reduced Dose PTCy
Other name:
MMF
Other name:
Cellcept®
Intervention type:
Other
Intervention name:
Patient Reported Outcomes
Description:
Survey assessments will be administered to study participants pre transplant, at Day +
100, Day + 180, and Day +365 post transplant.
Arm group label:
Regimen A (MAC: Busulfan and Fludarabine, PBSC HCT; Reduce Dose PTCy
Arm group label:
Regimen B (MAC: Fludarabine and TBI, PBSC HCT; Reduce Dose PTCy
Arm group label:
Regimen C (RIC: Fludarabine and Busulfan; PBSCT HCT; Reduced Dose PTCy
Arm group label:
Regimen D (RIC: Fludarabine and Melphalan; PBSCT HCT; Reduced Dose PTCy
Arm group label:
Regimen E (NMA: Fludarabine, Cyclophosphamide, and TBI; PBSCT HCT; Reduced Dose PTCy
Other name:
PRO
Intervention type:
Drug
Intervention name:
Melphalan
Description:
Given IV pre transplant as part of conditioning regimen
Arm group label:
Regimen D (RIC: Fludarabine and Melphalan; PBSCT HCT; Reduced Dose PTCy
Intervention type:
Radiation
Intervention name:
Total-body irradiation
Description:
Administered pre-transplant as part of conditioning regimen
Arm group label:
Regimen B (MAC: Fludarabine and TBI, PBSC HCT; Reduce Dose PTCy
Arm group label:
Regimen E (NMA: Fludarabine, Cyclophosphamide, and TBI; PBSCT HCT; Reduced Dose PTCy
Other name:
TBI
Intervention type:
Drug
Intervention name:
Cyclophosphamide
Description:
Given IV pre-transplant as part of conditioning regimen
Arm group label:
Regimen E (NMA: Fludarabine, Cyclophosphamide, and TBI; PBSCT HCT; Reduced Dose PTCy
Other name:
Cytoxan®
Summary:
The goal of this clinical trial is to determine the effectiveness of Reduced Dose
Post-Transplant Cyclophosphamide (PTCy) in patients with hematologic malignancies after
receiving an HLA-Mismatched Unrelated Donor (MMUD) . The main question[s] it aims to
answer are:
- Does a reduced dose of PTCy reduce the occurrence of infections in the first 100
days after transplant?
- Does a reduced dose of PTCy maintain the same level of protection against Graft
Versus Host Disease (GvHD) as the standard dose of PTCy?
Criteria for eligibility:
Criteria:
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. Patient or legally authorized representative has the ability to provide informed
consent according to the applicable regulatory and institutional requirements.
3. Stated willingness to comply with all study procedures and availability for the
duration of the study.
4. Planned MAC regimen as defined per study protocol
5. Available partially HLA-MMUD (4/8-7/8 at HLA-A, -B, -C, and -DRB1 is required) with
age ≥ 18 and ≤ 40 years (≤ 35 preferred).
6. Product planned for infusion is MMUD T-cell replete PBSC allograft
7. HCT-CI < 5. The presence of prior malignancy will not be used to calculate HCT-CI
for this trial to allow for the inclusion of patients with secondary or
therapy-related AML or MDS.
8. 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 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.
9. Cardiac function: Left ventricular ejection fraction ≥ 45% based on most recent
echocardiogram or multi-gated acquisition scan (MUGA) results.
10. Estimated creatinine clearance ≥ 45mL/min calculated by equation.
11. 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 (PFT) results
12. Liver function acceptable per local institutional guidelines
13. KPS of ≥ 70%
Stratum 2 Recipient Inclusion Criteria:
1. Age ≥18 years at the time of signing informed consent
2. Patient or legally authorized representative has the ability to provide informed
consent according to the applicable regulatory and local institutional requirements.
3. Stated willingness to comply with all study procedures and availability for the
duration of the study.
4. Planned NMA/RIC regimen per study protocol
5. Available partially HLA-MMUD (4/8-7/8 at HLA-A, -B, -C, and -DRB1 is required) with
age ≥ 18 and ≤ 40 years (≤ 35 preferred).
6. Product planned for infusion is MMUD T-cell replete PBSC allograft
7. 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. Higher risk CMML according to CMML-specific prognostic scoring system or high
risk MDS/MPN not otherwise specified are eligible, provided there is no
evidence of high-grade bone marrow fibrosis or massive splenomegaly at the time
of enrollment.
5. Patients with lymphoma with chemosensitive disease at the time of
transplantation
8. Cardiac function: Left ventricular ejection fraction ≥ 40% based on most recent
echocardiogram or MUGA results with no clinical evidence of heart failure
9. Estimated creatinine clearance ≥ 45mL/min calculated by equation
10. Pulmonary function: DLCO corrected for hemoglobin > 50% and FEV1 predicted >50%
based on most recent PFT results
11. Liver function acceptable per local institutional guidelines
12. KPS of ≥ 60%
Stratum 3 Recipient Inclusion Criteria:
1. Age ≥18 years at the time of signing informed consent
2. Patient or legally authorized representative has the ability to provide informed
consent according to the applicable regulatory and local institutional requirements.
3. Stated willingness to comply with all study procedures and availability for the
duration of the study.
4. Planned NMA/RIC regimen per study protocol
5. Available partially HLA-MMUD (4/8-7/8 at HLA-A, -B, -C, and -DRB1 is required) with
age ≥ 18 and ≤ 40 years (≤ 35 preferred).
6. Product planned for infusion is MMUD T-cell replete PBSC allograft
7. Diagnosis of primary myelofibrosis with risk features making them eligible for HCT.
Myelofibrosis secondary to essential thrombocythemia, polycythemia vera, or MDS with
grade 4 fibrosis are also eligible. Patients with a myelofibrosis diagnosis require
sponsor approval before enrolling.
8. Cardiac function: Left ventricular ejection fraction ≥ 40% based on most recent
echocardiogram or MUGA results with no clinical evidence of heart failure
9. Estimated creatinine clearance ≥ 45 mL/min calculated by equation
10. Pulmonary function: DLCO corrected for hemoglobin > 50% and FEV1 predicted >50%
based on most recent PFT results
11. Liver function acceptable per local institutional guidelines
12. KPS of ≥ 60%
Donor Inclusion Criteria (note: donors are not research subjects):
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, -DQB1, and
-DPB1.
3. Age ≥ 18 years and ≤ 40 years at the time of signing informed consent for PBSC
donation. Note: donors are preferred to be ≤ 35.
4. Meet the donor registries' medical suitability requirements for PBSC 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.
7. Must have the ability to give informed consent according to 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. Subjects with a prior allogeneic transplant
4. Subjects with an autologous transplant within the past 3 months
5. Females who are breast-feeding or pregnant
6. Uncontrolled bacterial, viral, or fungal infection at the time of the transplant
preparative regimen
7. Concurrent enrollment on a preventative GvHD and/or infectious disease prevention
clinical trial.
8. Subjects who undergo desensitization to reduce anti-donor HLA antibody levels prior
to transplant.
9. Patients who are HIV+ with persistently positive viral load. HIV-infected patients
on effective anti-retroviral therapy (ART) with undetectable viral load within 6
months are eligible for this trial. Patients with well controlled HIV are eligible
provided resistance panels are negative, the patient is compliant with ART, and
their disease remains well controlled.
Donor Exclusion Criteria:
1. Donor unwilling or unable to donate.
2. Recipient positive for HLA antibodies against a mismatched HLA in the selected donor
determined by the presence of donor specific HLA antibodies (DSA) to any mismatched
HLA allele/antigen at any of the following loci (HLA-A, -B, -C, -DRB1, DRB3, DRB4,
DRB5, -DQA1, - DQB1, -DPA1, -DPB1) with median fluorescence intensity (MFI) >3000 by
microarray-based single antigen bead testing. In patients receiving red blood cell
or platelet transfusions, DSA evaluation must be performed or repeated
post-transfusion and prior to donor mobilization and initiation of recipient
preparative regimen.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Mayo Clinic Arizona
Address:
City:
Phoenix
Zip:
85054
Country:
United States
Status:
Recruiting
Contact:
Last name:
Saurabh Chhabra, MD
Email:
Chhabra.Saurabh@mayo.edu
Contact backup:
Last name:
Saurabh Chhabra, MD
Facility:
Name:
City of Hope
Address:
City:
Duarte
Zip:
91010
Country:
United States
Status:
Recruiting
Contact:
Last name:
Monzr AlMalki, MD
Email:
malmalki@coh.org
Contact backup:
Last name:
Monzr AlMalki, MD
Facility:
Name:
Stanford University
Address:
City:
Stanford
Zip:
94305
Country:
United States
Status:
Recruiting
Contact:
Last name:
Sally Arai, MD
Email:
sara1@stanford.edu
Contact backup:
Last name:
Sally Arai, MD
Facility:
Name:
Mayo Clinic - Jacksonville
Address:
City:
Jacksonville
Zip:
32224
Country:
United States
Status:
Recruiting
Contact:
Last name:
Hemant Murthy, MD
Email:
Murthy.Hemant@mayo.edu
Contact backup:
Last name:
Hemant Murthy, MD
Facility:
Name:
University of Miami Sylvester Cancer Center
Address:
City:
Miami
Zip:
33136
Country:
United States
Status:
Recruiting
Contact:
Last name:
Antonio M Jimenez Jimenez, MD
Email:
amjimenez@miami.edu
Contact backup:
Last name:
Antonio M Jimenez Jimenez, MD
Facility:
Name:
Moffitt Cancer Center
Address:
City:
Tampa
Zip:
33612
Country:
United States
Status:
Recruiting
Contact:
Last name:
Farhad Khimani, MD
Email:
Farhad.Khimani@moffitt.org
Contact backup:
Last name:
Farhad Khimani, MD
Facility:
Name:
Dana Farber Cancer Institute
Address:
City:
Boston
Zip:
02215
Country:
United States
Status:
Recruiting
Contact:
Last name:
Mahasweta Gooptu, MD
Email:
Mahasweta_Gooptu@DFCI.HARVARD.EDU
Contact backup:
Last name:
Mahasweta Gooptu, MD
Facility:
Name:
Karmanos Cancer Institute
Address:
City:
Detroit
Zip:
48201
Country:
United States
Status:
Recruiting
Contact:
Last name:
Dipenkumar Modi, MD
Email:
modid@karmanos.org
Contact backup:
Last name:
Dipenkumar Modi, MD
Facility:
Name:
University of Minnesota
Address:
City:
Minneapolis
Zip:
55455
Country:
United States
Status:
Recruiting
Contact:
Last name:
Mark Juckett, MD
Email:
juck0001@umn.edu
Contact backup:
Last name:
Mark Juckett, MD
Facility:
Name:
Mayo Clinic Rochester
Address:
City:
Rochester
Zip:
55902
Country:
United States
Status:
Recruiting
Contact:
Last name:
Hassan Alkhateeb, MD
Email:
alkhateeb.hassan@mayo.edu
Contact backup:
Last name:
Hassan Alkhateeb, MD
Facility:
Name:
Barnes Jewish Hospital / Washington University
Address:
City:
Saint Louis
Zip:
63110
Country:
United States
Status:
Recruiting
Contact:
Last name:
Ramzi Abboud, MD
Email:
rabboud@wustl.edu
Contact backup:
Last name:
Ramzi Abboud, MD
Facility:
Name:
Memorial Sloan Kettering Cancer Center - Adults
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Contact:
Last name:
Brian Shaffer, MD
Email:
shaffeb1@mskcc.org
Contact backup:
Last name:
Brian Shaffer, MD
Facility:
Name:
University of North Carolina
Address:
City:
Chapel Hill
Zip:
27599
Country:
United States
Status:
Recruiting
Contact:
Last name:
Katarzyna Jamieson, MD
Email:
katarzyna_jamieson@med.unc.edu
Contact backup:
Last name:
Katarzyna Jamieson, MD
Facility:
Name:
Ohio State Medical Center
Address:
City:
Columbus
Zip:
43210
Country:
United States
Status:
Recruiting
Contact:
Last name:
Gabriela Sanchez Petitto, MD
Email:
gabriela.sanchezpetitto@osumc.edu
Contact backup:
Last name:
Gabriela Sanchez Petitto, MD
Facility:
Name:
Oregon Health & Science University
Address:
City:
Portland
Zip:
97239
Country:
United States
Status:
Recruiting
Contact:
Last name:
Rachel J Cook, M.D.
Email:
coora@ohsu.edu
Contact backup:
Last name:
Rachel J Cook, M.D.
Facility:
Name:
Abramson Cancer Center
Address:
City:
Philadelphia
Zip:
19104
Country:
United States
Status:
Recruiting
Contact:
Last name:
Shannon McCurdy, MD
Email:
Shannon.Mccurdy@pennmedicine.upenn.edu
Contact backup:
Last name:
Shannon McCurdy, MD
Facility:
Name:
TriStar Centennial
Address:
City:
Nashville
Zip:
37203
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jeremy Pantin, MD
Email:
Jeremy.Pantin@hcahealthcare.com
Contact backup:
Last name:
Jeremy Pantin, MD
Facility:
Name:
St. David's South Austin Medical Center
Address:
City:
Austin
Zip:
78704
Country:
United States
Status:
Recruiting
Contact:
Last name:
Uttam Rao, MD
Email:
Uttam.Rao@hcahealthcare.com
Contact backup:
Last name:
Uttam Rao, MD
Facility:
Name:
MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Betul Oran, MD
Email:
BOran@mdanderson.org
Contact backup:
Last name:
Betul Oran, MD
Facility:
Name:
Methodist Hospital San Antonio
Address:
City:
San Antonio
Zip:
78229
Country:
United States
Status:
Recruiting
Contact:
Last name:
Nosha Farhadfar, MD
Email:
Nosha.Farhadfar@hcahealthcare.com
Contact backup:
Last name:
Nosha Farhadfar, MD
Facility:
Name:
University of Virginia Health System
Address:
City:
Charlottesville
Zip:
22908
Country:
United States
Status:
Recruiting
Contact:
Last name:
Karen Ballen, M.D.
Contact backup:
Last name:
Karen Ballen, MD
Email:
kb3tc@virginia.edu
Contact backup:
Last name:
Karen Ballen, MD
Facility:
Name:
Fred Hutchinson Cancer Center
Address:
City:
Seattle
Zip:
98109
Country:
United States
Status:
Recruiting
Contact:
Last name:
Masumi Ueda Oshima, MD
Email:
mueda@fredhutch.org
Contact backup:
Last name:
Masumi Ueda Oshima, MD
Facility:
Name:
Froedtert & the Medical College of Wisconsin
Address:
City:
Milwaukee
Zip:
53226
Country:
United States
Status:
Recruiting
Contact:
Last name:
Sameem Abedin, MD
Start date:
December 8, 2023
Completion date:
June 30, 2026
Lead sponsor:
Agency:
Center for International Blood and Marrow Transplant Research
Agency class:
Other
Collaborator:
Agency:
National Marrow Donor Program
Agency class:
Other
Source:
Center for International Blood and Marrow Transplant Research
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06001385
