Study to Characterize Mismatched to Fully HLA-Matched Ossium HPC, Marrow and Living Donor Transplantation in Patients With Hematologic Malignancies
brief summary
Prospective, multi-center open label study of HLA-partially to fully matched allogeneic cryopreserved deceased donor bone marrow transplantation and living donor transplantation for patients with hematologic malignancies.
detailed description
This is a prospective, multi-center open label study of HLA-partially to fully matched allogeneic cryopreserved deceased donor bone marrow transplantation and living donor transplantation for patients with hematologic malignancies. The study will have block enrollment at each site (block size 3 patients). Patients will be enrolled in the following treatment arms for each block:
Experimental Arm:
Arm 1: Ossium HPC, marrow (n=100)
Observational arms:
Arm 2: Living mismatched unrelated PBSC donor (n=100) Arm 3: Living Haplo related PBSC donor (n=100)
The observational arm is standard of care arm. No prospective intervention will be specified, the data will be collected as per T\&E schedule. One hundred patients will be enrolled into each arm.
official title
A Multicenter, Open Label Study to Evaluate the Efficacy, Tolerability, and Safety of Partially to Fully HLA-Matched Allogeneic Cryopreserved Deceased-Donor Bone Marrow Transplantation and Living Donor Transplantation in Patients With Hematologic Malignancies