Trials / Recruiting
RecruitingNCT05589896
A First-in-Human Study of HLA-Partially to Fully Matched Allogenic Cryopreserved Deceased Donor Bone Marrow Transplantation for Patients With Hematologic Malignancies
- Status
- Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 12 (estimated)
- Sponsor
- Ossium Health, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2024-08-16
- Primary completion
- 2026-05-31
- Completion
- 2027-03-31
- First posted
- 2022-10-21
- Last updated
- 2026-02-24
Locations
9 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT05589896. Inclusion in this directory is not an endorsement.