OncRef

Clinical Trial: NCT04904588

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

Status:

ACTIVE NOT RECRUITING

Phase:

Phase 2

Lead Sponsor:Center for International Blood and Marrow Transplant Research
Information Provided By:Center for International Blood and Marrow Transplant Research
Last Update Posted:2026-03-18

Study Overview

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.

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

Conditions

Acute Lymphoblastic Leukemia, Acute Myelogenous Leukemia, Mixed Phenotype Acute Leukemia, Acute Leukemia, Myelodysplastic Syndromes, Chronic Myelogenous Leukemia, Chronic Lymphocytic Leukemia, Lymphoma

Intervention / Treatment

  • Drug: Busulfan
  • 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

Other Study ID Numbers

  • ACCESS

Start Date (Actual)

2021-09-30

Primary Completion Date (Estimated)

2026-08

Study Completion Date (Estimated)

2026-12

Enrollment (Estimated)

300

Study Type

Interventional

Phase

Phase 2