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HLA-Mismatched Unrelated Donor Bone Marrow Transplantation With Post-Transplantation Cyclophosphamide | Clinical Trials | Clareo Health

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HLA-Mismatched Unrelated Donor Bone Marrow Transplantation With Post-Transplantation Cyclophosphamide

A Multi-Center, Phase II Trial of HLA-Mismatched Unrelated Donor Bone Marrow Transplantation With Post-Transplantation Cyclophosphamide for Patients With Hematologic Malignancies

NCT02793544•Center for International Blood and Marrow Transplant Research

View on ClinicalTrials.gov

Summary

This is a multi-center, single arm Phase II study of hematopoietic cell transplantation (HCT) using human leukocyte antigen (HLA)-mismatched unrelated bone marrow transplantation donors and post-transplantation cyclophosphamide (PTCy), sirolimus and mycophenolate mofetil (MMF) for graft versus host disease (GVHD) prophylaxis in patients with hematologic malignancies.

Eligibility

Age

15 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age ≥ 15 years and \< 71 years at the time of signing the informed consent form
•2. Partially HLA-mismatched unrelated donor: HLA typing will be performed at high resolution (allele level) for the HLA-A, -B, -C, and -DRB1 loci; a minimum match of 4/8 at HLA-A, -B, -C, and -DRB1 is required
•3. Product planned for infusion is bone marrow
•4. Disease and disease status:
•1. Acute Leukemias or T lymphoblastic lymphoma in 1st or subsequent complete remission (CR): Acute lymphoblastic leukemia (ALL)/T lymphoblastic lymphoma; acute myelogenous leukemia (AML); acute biphenotypic leukemia (ABL); acute undifferentiated leukemia (AUL)
•2. Myelodysplastic Syndrome (MDS), fulfilling the following criteria: Subjects with de novo MDS who have or have previously had Intermediate-2 or High risk disease as determined by the International Prognostic Scoring System (IPSS). Current Intermediate-2 or High risk disease is not a requirement; Subjects must have \< 20% bone marrow blasts, assessed within 60 days of informed consent; Subjects may have received prior therapy for the treatment of MDS prior to enrollment
•3. Chronic Lymphocytic Leukemia (CLL) in CR if RIC is to be used; in CR or partial response (PR) if FIC is to be used
•4. Chronic myeloid leukemia (CML) in 1st or subsequent chronic phase characterized by \<10% blasts in the blood or bone marrow.
•5. Chemotherapy-sensitive lymphoma in status other than 1st CR
•5. Performance status: Karnofsky or Lansky score ≥ 60% (Appendix A)
+10 more criteria

Exclusion Criteria

•1. HLA-matched related or 8/8 allele matched (HLA-A, -B, -C, -DRB1) unrelated donor available. This exclusion does not apply to HIV-positive subjects who have a CCR5delta32 homozygous donor.
•2. Autologous HCT \< 3 months prior to the time of signing the informed consent form
•3. Females who are breast-feeding or pregnant
•4. HIV-positive subjects:
•1. Acquired immunodeficiency syndrome (AIDS) related syndromes or symptoms that may pose an excessive risk for transplantation-related morbidity as determined by the Treatment Review Committee (see Appendix D).
•2. Untreatable HIV infection due to multidrug ARV resistance. Subjects with a detectable or standard viral load \> 750 copies/mL should be evaluated with an HIV drug resistance test (HIV-1 genotype). The results should be included as part of the ARV review (described in Appendix D).
•3. May not be currently prescribed ritonavir, cobacistat and/or zidovudine
•5. Current uncontrolled bacterial, viral or fungal infection (currently taking medication with evidence of progression of clinical symptoms or radiologic findings)
•6. Prior allogeneic HCT
•7. History of primary idiopathic myelofibrosis
+1 more criteria

Locations (11)

Shands HealthCare & University of Florida

Gainesville, Florida, United States

University of Miami

Miami, Florida, United States

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States

University of Maryland Greenebaum Cancer Center

Baltimore, Maryland, United States

The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, United States

Karmanos Cancer Institute

Detroit, Michigan, United States

Memorial Sloan Kettering Cancer Center - Adults

New York, New York, United States

University of North Carolina Hospitals

Chapel Hill, North Carolina, United States

Ohio State Medical Center, James Cancer Center

Columbus, Ohio, United States

Virginia Commonwealth University Massey Cancer Center Bone Marrow Transplant Program

Richmond, Virginia, United States

Key Dates

Start Date

December 1, 2016

Primary Completion Date

March 1, 2020

Completion Date

March 1, 2020

Last Updated

August 6, 2025

Enrollment

ACTUAL participants

Conditions

Myelodysplastic Syndrome (MDS)Chronic Lymphocytic Leukemia (CLL)Chemotherapy-sensitive LymphomaAcute Lymphoblastic Leukemia (ALL)/T Lymphoblastic LymphomaAcute Myelogenous Leukemia (AML)Acute Biphenotypic Leukemia (ABL)Acute Undifferentiated Leukemia (AUL)

Interventions

Fludarabine

DRUG

Cyclophosphamide 14.5 mg/kg/day IV on Days -6, -5

DRUG

Total Body Irradiation (TBI) 200cGy on Day -1

RADIATION

Infusion of non-T-cell depleted bone marrow on Day 0

PROCEDURE

Busulfan

DRUG

Cyclophosphamide 50mg/kg/day IV on Days -2,-1

DRUG

Cyclophosphamide 50mg/kg/day IV on Days -5,-4

DRUG

Total Body Irradiation (TBI) 200cGy twice a day on Days -3, -2, -1

RADIATION

Post-HCT Cyclophosphamide 50mg/kg IV on Day+3, +4

DRUG

Sirolimus

DRUG

Mycophenolate mofetil

DRUG

G-CSF

DRUG

Pre-HCT Mesna on Days -6 and -5

DRUG

Pre-HCT Mesna on Days -2 and -1

DRUG

Pre-HCT Mesna on Days -5 and -4

DRUG

Post-HCT Mesna

DRUG

Haplo-identical Transplantation for Severe Aplastic Anemia, Hypo-plastic MDS and PNH Using Peripheral Blood Stem Cells and Post-transplant Cyclophosphamide for GVHD Prophylaxis

NCT03520647

Severe Aplastic Anemia (SAA)Hypo-Plastic Myelodysplastic Syndrome (MDS)+1 more

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RECRUITING

Registry Platform Hematologic Malignancies (RUBIN) - Extension of Tumor Registry Lymphatic Neoplasms

NCT06043011

Chronic Lymphocytic Leukemia (CLL)Diffuse Large B-cell Lymphoma (DLBCL)+4 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 6, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

HLA-Mismatched Unrelated Donor Bone Marrow Transplantation With Post-Transplantation Cyclophosphamide

Inclusion Criteria

Exclusion Criteria

Haplo-identical Transplantation for Severe Aplastic Anemia, Hypo-plastic MDS and PNH Using Peripheral Blood Stem Cells and Post-transplant Cyclophosphamide for GVHD Prophylaxis

Registry Platform Hematologic Malignancies (RUBIN) - Extension of Tumor Registry Lymphatic Neoplasms

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