Actively Recruiting
A First-in-Human Study of HLA-Partially to Fully Matched Allogenic Cryopreserved Deceased Donor Bone Marrow Transplantation for Patients With Hematologic Malignancies
Led by Ossium Health, Inc. · Updated on 2026-02-24
12
Participants Needed
9
Research Sites
43 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and feasibility of using bone marrow transplants from deceased donors in patients with acute and chronic leukemias, myelodysplastic syndrome, and certain lymphomas. The trial is a first-in-human study that explores how well these transplants work when combined with different conditioning treatments before transplantation. This study is led by Ossium Health, Inc. and includes adult patients who meet specific matching and health criteria. Participants receive one of several pre-transplant conditioning regimens, either myeloablative conditioning (MAC) or reduced intensity conditioning (RIC), involving various combinations of chemotherapy drugs and total body irradiation. After the transplant of Ossium HPC, Marrow, patients receive post-transplant treatments including Cyclophosphamide, Tacrolimus, Mycophenolate Mofetil, and Filgrastim. The study has two experimental cohorts and includes close monitoring after transplantation. During the study, patients are monitored closely for safety outcomes such as neutrophil engraftment by day 28 and serious adverse events by day 56, with follow-up continuing for one year. Researchers will assess immune recovery, transplant-related complications like graft-versus-host disease, infections, and disease relapse rates. The total participation includes a safety evaluation period of 56 days and extended follow-up to track longer-term outcomes and survival.
CONDITIONS
Brief Title
A First-in-Human Study of HLA-Partially to Fully Matched Allogenic Cryopreserved Deceased Donor Bone Marrow Transplantation for Patients With Hematologic Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to provide informed consent according to local requirements
- Male or female aged 18 to 65 years for myeloablative conditioning or 18 to 75 years for reduced intensity conditioning
- Require allogeneic hematopoietic cell transplantation as determined by treating physician
- High-resolution HLA partially or fully matched (4-8/8 alleles) to Ossium HPC, Marrow product
- Willingness to comply with all study procedures and availability for study duration
- Diagnosed with malignant hematologic disease including acute leukemias, myelodysplastic syndrome without fibrosis, chronic leukemias in first remission or beyond with ≤5% marrow blasts and no circulating blasts or extra-medullary disease within 42 days prior to conditioning
- Chemosensitive non-Hodgkin's lymphomas, Hodgkin's lymphoma, or cutaneous T cell lymphomas in first remission or beyond documented by imaging and bone marrow assessment within 42 days prior to conditioning
- Karnofsky performance status score ≥70% for myeloablative conditioning or ≥60% for reduced intensity conditioning
- Hematopoietic cell transplantation comorbidity index ≤5
- Adequate organ function including cardiac, pulmonary, hepatic, and renal criteria as specified
You will not qualify if you...
- Availability of suitable graft from living donor (7/8 or 8/8 HLA-matched related or unrelated donors, haploidentical donors, or cord blood donors)
- Prior autologous or allogeneic hematopoietic cell transplantation
- Pregnancy or lactation
- Ongoing treatment with investigational drug for disease-related treatment within 5 half-lives of the drug
- Current uncontrolled bacterial, viral, or fungal infection with evidence of progression
- Any physical or psychological condition or exam finding that precludes participation as judged by investigator
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Varies by regimen; typically days to a few weeks before transplant
Participants receive pre-transplant conditioning treatment with one of four regimens to prepare for bone marrow transplantation.
Multiple visits as part of conditioning treatment
Duration - Approximately 56 days (post-transplant observation period)
Participants undergo bone marrow transplantation with Ossium HPC, Marrow followed by post-transplant treatment including medications to support recovery and prevent complications.
Frequent visits during initial 56 days post-transplant
Duration - Up to 12 months
Participants are monitored for outcomes including blood cell recovery, adverse events, graft versus host disease, infections, and survival up to one year after transplant.
Periodic visits for assessments up to 1 year after transplant
Trial Site Locations
Total: 9 locations
1
City of Hope
Duarte, California, United States, 91010
Actively Recruiting
2
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
3
Emory University - Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Actively Recruiting
4
Henry Ford Cancer Institute
Detroit, Michigan, United States, 48202
Actively Recruiting
5
Oregon Health and Science University
Portland, Oregon, United States, 97239
Actively Recruiting
6
TriStar Bone Marrow Transplant
Nashville, Tennessee, United States, 37203
Actively Recruiting
7
St. David's South Austin Medical Center
Austin, Texas, United States, 78745
Actively Recruiting
8
Methodist Hospital, Texas Transplant
San Antonio, Texas, United States, 78229
Actively Recruiting
9
University of Utah - Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
Actively Recruiting
Research Team
P
Preethi Prasad, M.Sc.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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