A First-in-Human Study of HLA-Partially to Fully Matched Allogenic Cryopreserved Deceased Donor Bone Marrow Transplantation for Patients With Hematologic Malignancies

Ossium Health, Inc.

Summary

The goal of this clinical trial is to determine the safety and feasibility of allogeneic transplantation with bone marrow from a deceased donor in patients with acute and chronic leukemias, myelodysplastic syndrome, and certain lymphomas. Patients will either receive myeloablative conditioning or reduced intensity conditioning regimen prior to the transplant. Patients will be followed for 56 days for safety endpoints and remain in follow-up for one year.

Eligibility

Age range: 18–75 years
Sex: All
Healthy volunteers: No

Detailed criteria

Inclusion Criteria: * Patient has the ability to provide informed consent according to the applicable regulatory and local institutional requirements * Male or female, aged ≥18 and ≤65 years for patients receiving MAC (Regimen A or Regimen B); aged ≥18 and ≤75 years for patients receiving RIC (Regimen C or D) * Patient must require allogeneic HCT per the discretion of the treating physician * Patient must be high-resolution, HLA partially or fully matched (4-8/8 allele matched at HLA-A, -B, -C, DRB1) to an available Ossium HPC, Marrow product * Stated willingness to comply with all study proc…

Interventions

Other
Ossium HPC Marrow, Bone Marrow Transplant
Hematopoetic Cell Transplantation
Other
Pre-transplant conditioning - Myeloablative (MAC)
Regimen A or Regimen B
Other
Pre-transplant conditioning - Reduced Intensity (RIC)
Regimen C or Regimen D
Other
Post-transplant treatment
Post-transplant treatment

Locations (9)

City of Hope
Duarte, California
Moffitt Cancer Center
Tampa, Florida
Emory University - Winship Cancer Institute
Atlanta, Georgia
Henry Ford Cancer Institute
Detroit, Michigan
Oregon Health and Science University
Portland, Oregon
TriStar Bone Marrow Transplant
Nashville, Tennessee