HLA-Mismatched Unrelated Donor Hematopoietic Cell Transplantation With Post-Transplantation Cyclophosphamide (ACCESS)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT04904588 |
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Recruitment Status :
Recruiting
First Posted : May 27, 2021
Last Update Posted : March 23, 2023
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Sponsor:
Center for International Blood and Marrow Transplant Research
Collaborator:
National Marrow Donor Program
Information provided by (Responsible Party):
Center for International Blood and Marrow Transplant Research
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Brief Summary:
This is a prospective, multi-center, Phase II study of hematopoietic cell transplantation (HCT) using human leukocyte antigen (HLA)-mismatched unrelated donors (MMUD) for peripheral blood stem cell transplant in adults and bone marrow stem cell transplant in children. Post-transplant cyclophosphamide (PTCy), tacrolimus and mycophenolate mofetil (MMF) will be used for for graft versus host disease (GVHD) prophylaxis. This trial will study how well this treatment works in patients with hematologic malignancies.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Acute Lymphoblastic Leukemia Acute Myelogenous Leukemia Mixed Phenotype Acute Leukemia Acute Leukemia Myelodysplastic Syndromes Chronic Myelogenous Leukemia Chronic Lymphocytic Leukemia Lymphoma | Drug: Busulfan Drug: Fludarabine Radiation: Total-body irradiation Drug: Cyclophosphamide Drug: Melphalan Procedure: PBSC Hematopoietic Stem Cell Transplantation (HSCT) Procedure: Bone Marrow Hematopoietic Stem Cell Transplantation Drug: Post-transplant Cyclophosphamide Drug: Mesna Drug: Tacrolimus Drug: Mycophenolate Mofetil Other: Patient-Reported Outcomes | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 300 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Multi-Center, Phase II Trial of HLA-Mismatched Unrelated Donor Hematopoietic Cell Transplantation With Post-Transplantation Cyclophosphamide for Patients With Hematologic Malignancies |
| Actual Study Start Date : | September 30, 2021 |
| Estimated Primary Completion Date : | July 2024 |
| Estimated Study Completion Date : | July 2024 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Organ Donation
Drug Information available for:
Cyclophosphamide
Genetic and Rare Diseases Information Center resources:
Myeloid Leukemia
Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Lymphoblastic Lymphoma
Acute Non Lymphoblastic Leukemia
Myelodysplastic Syndromes
Lymphosarcoma
Chronic Lymphocytic Leukemia
Acute Graft Versus Host Disease
Chronic Myeloid Leukemia
Acute Leukemia of Ambiguous Lineage
Chronic Graft Versus Host Disease
Chronic Myeloproliferative Disorders
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Regimen A (MAC: busulfan and fludarabine, PBSC HCT)
Patients receive:
Patients receive a peripheral blood stem cell (PBSC) graft infusion from a mismatched unrelated donor on Day 0. |
Drug: Busulfan
Given IV or PO pre-transplant as part of conditioning regimen
Other Name: Busulfex® Drug: Fludarabine Given IV pre-transplant as part of conditioning regimen
Other Name: Fludara® Procedure: PBSC Hematopoietic Stem Cell Transplantation (HSCT) Peripheral blood stem cell graft is infused from a mismatched unrelated donor on Day 0.
Other Names:
Drug: Post-transplant Cyclophosphamide Cyclophosphamide (50 mg/kg) is administered on Day +3 and on Day +4 post-transplant as an IV infusion over 1-2 hours.
Other Name: Cytoxan® Drug: Mesna Mesna is given in divided doses IV 30 min pre- and at 3, 6, and 8 hours post-cyclophosphamide.
Other Name: Mesnex® Drug: Tacrolimus 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 90-100 days post HCT. Drug: Mycophenolate Mofetil 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.
Other Names:
Other: Patient-Reported Outcomes Survey assessments will be administered to study participants pre- and post-transplant. |
|
Experimental: Regimen B (MAC: Fludarabine and TBI; PBSC HCT)
Patients receive:
Patients receive a PBSC graft infusion from a mismatched unrelated donor on Day 0. |
Drug: Fludarabine
Given IV pre-transplant as part of conditioning regimen
Other Name: Fludara® Radiation: Total-body irradiation Administered pre-transplant as part of conditioning regimen
Other Name: TBI Procedure: PBSC Hematopoietic Stem Cell Transplantation (HSCT) Peripheral blood stem cell graft is infused from a mismatched unrelated donor on Day 0.
Other Names:
Drug: Post-transplant Cyclophosphamide Cyclophosphamide (50 mg/kg) is administered on Day +3 and on Day +4 post-transplant as an IV infusion over 1-2 hours.
Other Name: Cytoxan® Drug: Mesna Mesna is given in divided doses IV 30 min pre- and at 3, 6, and 8 hours post-cyclophosphamide.
Other Name: Mesnex® Drug: Tacrolimus 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 90-100 days post HCT. Drug: Mycophenolate Mofetil 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.
Other Names:
Other: Patient-Reported Outcomes Survey assessments will be administered to study participants pre- and post-transplant. |
|
Experimental: Regimen C (RIC: Fludarabine and Busulfan; PBSC HCT)
Patients receive:
Patients receive a PBSC graft infusion from a mismatched unrelated donor on Day 0. |
Drug: Busulfan
Given IV or PO pre-transplant as part of conditioning regimen
Other Name: Busulfex® Drug: Fludarabine Given IV pre-transplant as part of conditioning regimen
Other Name: Fludara® Procedure: PBSC Hematopoietic Stem Cell Transplantation (HSCT) Peripheral blood stem cell graft is infused from a mismatched unrelated donor on Day 0.
Other Names:
Drug: Post-transplant Cyclophosphamide Cyclophosphamide (50 mg/kg) is administered on Day +3 and on Day +4 post-transplant as an IV infusion over 1-2 hours.
Other Name: Cytoxan® Drug: Mesna Mesna is given in divided doses IV 30 min pre- and at 3, 6, and 8 hours post-cyclophosphamide.
Other Name: Mesnex® Drug: Tacrolimus 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 90-100 days post HCT. Drug: Mycophenolate Mofetil 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.
Other Names:
Other: Patient-Reported Outcomes Survey assessments will be administered to study participants pre- and post-transplant. |
|
Experimental: Regimen D (RIC: Fludarabine and Melphalan; PBSC HCT)
Patients receive:
Patients receive a PBSC graft infusion from a mismatched unrelated donor on Day 0. |
Drug: Fludarabine
Given IV pre-transplant as part of conditioning regimen
Other Name: Fludara® Drug: Melphalan Given IV pre-transplant as part of conditioning regimen Procedure: PBSC Hematopoietic Stem Cell Transplantation (HSCT) Peripheral blood stem cell graft is infused from a mismatched unrelated donor on Day 0.
Other Names:
Drug: Post-transplant Cyclophosphamide Cyclophosphamide (50 mg/kg) is administered on Day +3 and on Day +4 post-transplant as an IV infusion over 1-2 hours.
Other Name: Cytoxan® Drug: Mesna Mesna is given in divided doses IV 30 min pre- and at 3, 6, and 8 hours post-cyclophosphamide.
Other Name: Mesnex® Drug: Tacrolimus 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 90-100 days post HCT. Drug: Mycophenolate Mofetil 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.
Other Names:
Other: Patient-Reported Outcomes Survey assessments will be administered to study participants pre- and post-transplant. |
|
Experimental: Regimen E (NMA: Fludarabine, Cyclophosphamide, TBI; PBSC HCT)
Patients receive:
Patients receive a PBSC graft infusion from a mismatched unrelated donor on Day 0. |
Drug: Fludarabine
Given IV pre-transplant as part of conditioning regimen
Other Name: Fludara® Radiation: Total-body irradiation Administered pre-transplant as part of conditioning regimen
Other Name: TBI Drug: Cyclophosphamide Given IV pre-transplant as part of conditioning regimen
Other Name: Cytoxan® Procedure: PBSC Hematopoietic Stem Cell Transplantation (HSCT) Peripheral blood stem cell graft is infused from a mismatched unrelated donor on Day 0.
Other Names:
Drug: Post-transplant Cyclophosphamide Cyclophosphamide (50 mg/kg) is administered on Day +3 and on Day +4 post-transplant as an IV infusion over 1-2 hours.
Other Name: Cytoxan® Drug: Mesna Mesna is given in divided doses IV 30 min pre- and at 3, 6, and 8 hours post-cyclophosphamide.
Other Name: Mesnex® Drug: Tacrolimus 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 90-100 days post HCT. Drug: Mycophenolate Mofetil 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.
Other Names:
Other: Patient-Reported Outcomes Survey assessments will be administered to study participants pre- and post-transplant. |
|
Experimental: Regimen F (MAC: Busulfan and Cyclophosphamide; BM HCT)
Patients receive:
Patients receive a bone marrow (BM) graft infusion from a mismatched unrelated donor on Day 0. |
Drug: Busulfan
Given IV pre-transplant as part of conditioning regimen
Other Name: Busulfex® Drug: Cyclophosphamide Given IV pre-transplant as part of conditioning regimen
Other Name: Cytoxan® Procedure: Bone Marrow Hematopoietic Stem Cell Transplantation Bone marrow graft is infused from a mismatched unrelated donor on Day 0.
Other Names:
Drug: Post-transplant Cyclophosphamide Cyclophosphamide (50 mg/kg) is administered on Day +3 and on Day +4 post-transplant as an IV infusion over 1-2 hours.
Other Name: Cytoxan® Drug: Mesna Mesna is given in divided doses IV 30 min pre- and at 3, 6, and 8 hours post-cyclophosphamide.
Other Name: Mesnex® Drug: Tacrolimus 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 90-100 days post HCT. Drug: Mycophenolate Mofetil 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.
Other Names:
Other: Patient-Reported Outcomes Survey assessments will be administered to study participants pre- and post-transplant. |
|
Experimental: Regimen G (MAC: Cyclophosphamide and TBI; BM HCT)
Patients receive:
Patients receive a BM graft infusion from a mismatched unrelated donor on Day 0. |
Radiation: Total-body irradiation
Administered pre-transplant as part of conditioning regimen
Other Name: TBI Drug: Cyclophosphamide Given IV pre-transplant as part of conditioning regimen
Other Name: Cytoxan® Procedure: Bone Marrow Hematopoietic Stem Cell Transplantation Bone marrow graft is infused from a mismatched unrelated donor on Day 0.
Other Names:
Drug: Post-transplant Cyclophosphamide Cyclophosphamide (50 mg/kg) is administered on Day +3 and on Day +4 post-transplant as an IV infusion over 1-2 hours.
Other Name: Cytoxan® Drug: Mesna Mesna is given in divided doses IV 30 min pre- and at 3, 6, and 8 hours post-cyclophosphamide.
Other Name: Mesnex® Drug: Tacrolimus 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 90-100 days post HCT. Drug: Mycophenolate Mofetil 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.
Other Names:
Other: Patient-Reported Outcomes Survey assessments will be administered to study participants pre- and post-transplant. |
Primary Outcome Measures :
- Overall Survival [ Time Frame: 1 year post HCT ]
Secondary Outcome Measures :
- Event-free survival [ Time Frame: 1 year post-HCT ]Defined as graft failure, relapse or progression of underlying disease, death, grade 3-4 acute GVHD, or NIH-severe chronic GVHD.
- GVHD, relapse free survival [ Time Frame: 1 year post-HCT ]Defined as relapse or progression of underling disease, graft failure, grade III-IV acute GVHD, chronic GVHD requiring systemic immune suppression, or death by any cause.
- Modified GVHD, relapse free survival [ Time Frame: 1 year post-HCT ]Defined as relapse or progression of underling disease, graft failure, grade III-IV acute GVHD, NIH moderate or severe chronic GVHD, or death by any cause.
- Progression-free survival [ Time Frame: 1 year post-HCT ]
- Cumulative incidence of nonrelapse mortality [ Time Frame: Day +100 and 1 year post-HCT ]
- Event-Free Survival based on donor HLA match grade and donor age (7/8 versus <7/8) [ Time Frame: 1 year post-HCT ]
- Overall Survival based on donor HLA match grade and donor age (7/8 versus <7/8) [ Time Frame: 1 year post-HCT ]
- Cumulative incidence of neutrophil recovery [ Time Frame: Day +100 post-HCT ]Defined as neutrophil count ≥500/mm^3 for 3 consecutive days post-HCT.
- Kinetics of neutrophil recovery [ Time Frame: Day +100 post-HCT ]Defined as the evaluation of the time it takes for neutrophil count recovery to occur in the study subjects.
- Cumulative incidence of platelet recovery [ Time Frame: Day +100 post-HCT ]Defined as platelet count ≥20,000/mm^3 or ≥50,000/mm^3 with no platelet transfusions within seven days.
- Kinetics of platelet recovery [ Time Frame: Day +100 post-HCT ]Defined as the evaluation of the time it takes for platelet count recovery to occur in the study subjects.
- Cumulative incidence of primary graft failure [ Time Frame: Day +28 post-HCT ]
- Donor chimerism [ Time Frame: Day +100 post-HCT ]Strata 2 and 3 only. Percent of donor chimerism via peripheral blood
- Cumulative incidence of acute GVHD [ Time Frame: Day +100 post-HCT ]
- Cumulative incidence of chronic GVHD [ Time Frame: 1 year post-HCT ]
- Cumulative incidence of BK and cytomegalovirus (CMV) viral infections [ Time Frame: Days +100 and +180 post-HCT ]
- Cumulative incidence of relapse/progression [ Time Frame: 1 year post-HCT ]
- Incidence of cytokine release syndrome (CRS) [ Time Frame: Day +14 post-HCT ]Overall incidence of CRS of any grade and grade 3 or 4 CRS post-transplant
- Cumulative incidence of secondary graft failure [ Time Frame: 1 year post-HCT ]
- Overall Toxicity [ Time Frame: 1 year post-HCT ]To tabulate adverse events (AEs) experienced by recipients, defined as grade 3-5 unexpected and Grade 5 expected AEs, according to CTCAE version 5.0.
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Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 1 Year and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Stratum 1 Recipient Inclusion Criteria:
- 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
- Planned MAC regimen as defined per protocol
- Available partially HLA-MMUD (4/8-7/8 at HLA-A, -B, -C, and -DRB1 is required) with age < 35 years
- Product planned for infusion is PBSC
- HCT Comorbidity Index (HCT-CI) < 5
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One of the following diagnoses:
- 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.
- 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.
- Cardiac function: Left ventricular ejection fraction > 45% based on most recent echocardiogram or multigated acquisition scan (MUGA) results
- Estimated creatinine clearance > 60 mL/min calculated by equation
- 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
- Liver function acceptable per local institutional guidelines
- Karnofsky performance status (KPS) of > 70%
- 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
- Age > 18 years at the time of signing informed consent
- Planned NMA/RIC regimen as defined per protocol
- Available partially HLA-MMUD (4/8-7/8 at HLA-A, -B, -C, and -DRB1 is required) with age < 35 years
- Product planned for infusion is PBSC
-
One of the following diagnoses:
- 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.
- 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.
- Patients with chronic lymphocytic leukemia (CLL) or other leukemias (including prolymphocytic leukemia) with chemosensitive disease at time of transplantation
- Patients with lymphoma with chemosensitive disease at the time of transplantation
- Cardiac function: Left ventricular ejection fraction > 45% based on most recent echocardiogram or MUGA results with no clinical evidence of heart failure
- Estimated creatinine clearance > 60 mL/min calculated by equation
- Pulmonary function: DLCO corrected for hemoglobin > 50% and FEV1 predicted > 50% based on most recent pulmonary function test results
- Liver function acceptable per local institutional guidelines
- KPS of > 60%
- 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
- Age > 1 years and < 21 years at the time of signing informed consent
- Partially HLA-MMUD (4/8-7/8 at HLA-A, -B, -C, and -DRB1 is required) with age < 35 years
- Product planned for infusion is BM
- Planned MAC regimen as defined per protocol
-
One of the following diagnosis:
- 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.
- 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.
- 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.
- 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.
- Chemotherapy sensitive lymphoma in at least partial remission (PR)
- KPS or Lansky performance score ≥ 70%
- Cardiac function: Left ventricular ejection fraction of ≥ 50% and shortening fraction of ≥ 27% based on most recent echocardiogram
- Glomerular Filtration Rate (GFR) of ≥ 60ml/min/1.73m2 measured by nuclear medicine scan or calculated from a 24 hour urine collection
- 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.
- Hepatic: Total bilirubin ≤ 2.5 mg/dL and alanine aminotransferase (ALT), aspartate aminotransferase (AST) < 3x the upper limit of normal
- 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.
- 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:
- 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)
- Donor must be typed at high-resolution for a minimum of HLA-A, -B, -C, -DRB1, -DQB1, and -DPB1
- Age > 18 years and < 35 years at the time of signing informed consent
- Meet the donor registries' medical suitability requirements for PBSC or BM donation
- 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.
- Must agree to donate PBSC (or BM for stratum 3)
- 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):
- Suitable HLA-matched related or 8/8 high-resolution matched unrelated donor available
- Subject unwilling or unable to give informed consent, or unable to comply with the protocol including required follow-up and testing
- Primary myelofibrosis or myelofibrosis secondary to essential thrombocythemia, polycythemia vera, or MDS with grade 4 marrow fibrosis
- Subjects with a prior allogeneic HSC transplant
- Subjects with an autologous HSC transplant within the past 3 months
- Females who are breast-feeding or pregnant
- Uncontrolled bacterial, viral or fungal infection at the time of the transplant preparative regimen
- Concurrent enrollment on other interventional GVHD clinical trial (enrollment on supportive care trials may be allowed after discussion with Principal Investigators)
- Subjects who undergo desensitization to reduce anti-donor HLA antibody levels prior to transplant.
- 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:
- Donor unwilling or unable to donate
- Recipient positive anti-donor 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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04904588
Contacts
| Contact: Janelle Olson, PhD | 763-406-8147 | jolson@nmdp.org | |
| Contact: Erin Leckrone | 763-406-5124 | eleckron@nmdp.org |
Locations
Show 37 study locations
Sponsors and Collaborators
Center for International Blood and Marrow Transplant Research
National Marrow Donor Program
Investigators
| Principal Investigator: | Steven Devine, MD | NMDP/Be The Match |
| Responsible Party: | Center for International Blood and Marrow Transplant Research |
| ClinicalTrials.gov Identifier: | NCT04904588 |
| Other Study ID Numbers: |
ACCESS |
| First Posted: | May 27, 2021 Key Record Dates |
| Last Update Posted: | March 23, 2023 |
| Last Verified: | March 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Center for International Blood and Marrow Transplant Research:
|
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 Diseases |
Bone Marrow Diseases Precancerous Conditions Leukemia, Lymphoid Leukemia, B-Cell Leukemia, Myeloid Cyclophosphamide Mesna Tacrolimus Busulfan Fludarabine Total Body Irradiation Melphalan Mycophenolate mofetil Immunosuppressive Agents Immunologic Factors |
Additional relevant MeSH terms:
|
Lymphoma Leukemia Preleukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Lymphoid Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Myeloid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid, Acute Myelodysplastic Syndromes Acute Disease Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases |
Immunoproliferative Disorders Immune System Diseases Pathologic Processes Bone Marrow Diseases Hematologic Diseases Precancerous Conditions Leukemia, B-Cell Myeloproliferative Disorders Disease Attributes Mycophenolic Acid Cyclophosphamide Melphalan Busulfan Fludarabine Tacrolimus |