A First-in-Human Study of HLA-Partially to Fully Matched Allogenic Cryopreserved Deceased Donor Bone Marrow Transplantation for Patients With Hematologic Malignancies
NCT05589896 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 12
Last updated 2026-02-24
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.
Conditions
- Acute Leukemia
- Acute Lymphoblastic Leukemia
- Acute Myeloid Leukemia
- Acute Biphenotypic Leukemia
- Acute Undifferentiated Leukemia
- CLL (Chronic Lymphocytic Leukemia)
- Chronic Myeloid Leukemia (CML)
- MDS (Myelodysplastic Syndrome)
- Non-Hodgkin Lymphomas
- Hodgkins Lymphoma
- Cutaneous T Cell Lymphomas (CTCL)
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
Sponsors & Collaborators
-
Ossium Health, Inc.
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-08-16
- Primary Completion
- 2026-05-31
- Completion
- 2027-03-31
Countries
- United States
Study Locations
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