NCT02623439

A Study of Haploidentical Bone Marrow Transplant for Patients With Hematologic Malignancies

A Phase 2 Study of Nonmyeloablative Conditioning With Transplantation of Partially Human Leukocyte Antigen (HLA)-Mismatched Bone Marrow and Post-transplant Cyclophosphamide for Patients With Hematologic Malignancies

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: University of California, San Diego · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The primary objective is to determine overall survival 180 days after transplantation involving HLA-haploidentical stem cell/bone marrow graft, and post-transplant Cy.

Detailed description

Study Design: This is a single center Phase 2 study of myeloablative (MA) and nonmyeloablative (NMA) conditioning, transplantation of partially HLA-mismatched bone marrow or peripheral blood stem cells and post-transplantation cyclophosphamide (Cy) in patients with hematologic malignancies including: 1. Acute lymphoblastic leukemia/lymphoma, acute myelogenous leukemia, and Burkitt's lymphoma in remission. 2. Relapsed lymphoma, including marginal zone B cell lymphoma, follicular lymphoma, and chemotherapy-sensitive large-cell or Hodgkin lymphoma. 3. Myelodysplastic Syndrome (MDS) 4. Blastic plasmacytoid dendritic cell neoplasm Primary Objective: The primary objective is to determine overall survival 180 days after transplantation involving Myeloablative and Non myeloablative conditioning, HLA-haploidentical marrow or peripheral blood stem cell grafts, and post-transplant Cyclophosphamide as GVHD prophylaxis. Secondary Objectives: Secondary objectives include estimating overall and progression-free survival at 100 days, 180 days, and one year after transplantation, treatment-related mortality, incidence of neutrophil and platelet recovery or engraftment, incidence of graft failure, cumulative incidence of acute and chronic Graft versus Host Disease (GVHD), incidence of infections, and cumulative incidence of relapse/progression. The investigators will also examine the amount of time to transplant (day of unrelated search initiation to day 0).

Conditions

• Hematologic Malignancies

Interventions

Type	Name	Description
DRUG	Cyclophosphamide 50 mg/kg IV Days 3 and 4 post transplant	Cyclophosphamide 50 mg/kg IV Days 3 and 4 post transplant

Timeline

• Start date: 2012-09-21
• Primary completion: 2016-05-12
• Completion: 2023-01-01
• First posted: 2015-12-07
• Last updated: 2025-11-10
• Results posted: 2025-11-10

Locations

1 site across 1 country: United States