Clinical Trials Search
Clinical Trial 18814
Interventions:busulfan; cyclophosphamide; cytoxan (cyclophosphamide); fludarabine (Fludarabine phosphate)
Study Type: Treatment
Phase of Study: Phase II
- Farhad Khimani
A Multi-Center, Phase II Trial of HLA-Mismatched Unrelated Donor Bone Marrow Transplantation with Post-Transplantation Cyclophosphamide for Patients with Hematologic Malignancies
The purpose of this study is to see if using a mismatched unrelated donor (MMUD) is safe and effective in participants undergoing bone marrow transplant.
The primary objective is to determine OS through 1 year after HLA MMUD bone marrow HCT using PTCy. Secondary objectives include estimating the following: PFS at Day+180 and 1 year post-HCT; TRM at Day+100, Day+180, and 1 year post-HCT; cumulative incidence of neutrophil recovery; cumulative incidence of platelet recovery; cumulative incidence of primary graft failure; donor chimerism; cumulative incidences of aGVHD and cGVHD; cumulative incidences of viral reactivations and infections; cumulative incidence of relapse/progression; and cumulative incidences of TMA and VOD/SOS. The proportion of subjects proceeding to HCT after informed consent will be described. The donor selection characteristics will also be described. Time to donor identification from the search request will be described. Incidence of development of donor clonal hematopoiesis will be described. Analysis of long-term survivors will be performed for subjects who consent to the CIBMTR Research Database protocol using routine data collection forms and time points per CIBMTR requirements.