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
136 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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...
- Patient can provide informed consent as required by local rules
- Male or female aged 18 to 65 years for myeloablative conditioning or 18 to 75 years for reduced intensity conditioning
- Requires allogeneic hematopoietic cell transplantation as determined by treating physician
- High-resolution HLA partial or full match (4-8/8 alleles) with available Ossium HPC Marrow product
- Willing to comply with all study procedures and available for entire study duration
- Diagnosed with malignant hematologic disease including acute leukemia types, myelodysplastic syndrome without fibrosis, or chronic leukemia in remission with ≤5% marrow blasts and no circulating or extramedullary disease within 42 days before conditioning
- Chemosensitive non-Hodgkin's lymphoma, Hodgkin's lymphoma, or cutaneous T cell lymphoma in remission confirmed by PET/CT and bone marrow assessment within 42 days before conditioning
- Karnofsky performance status score ≥70% for myeloablative conditioning or ≥60% for reduced intensity conditioning
- HCT comorbidity index ≤5
- Adequate organ function including cardiac LVEF ≥40% (RIC) or ≥45% (MAC), pulmonary function tests ≥50% predicted, hepatic function with bilirubin ≤2.0 mg/dL and liver enzymes <3x upper normal limit unless disease related, and renal function with creatinine clearance >60 mL/min/1.73m2 if serum creatinine outside normal range
You will not qualify if you...
- Suitable graft available from living donors including 7/8 or 8/8 HLA-matched related/unrelated donors, haploidentical donors, or cord blood donors
- Previous autologous or allogeneic hematopoietic cell transplant
- Pregnancy or breastfeeding
- Ongoing treatment with investigational drugs for the disease within 5 drug half-lives
- Current uncontrolled bacterial, viral, or fungal infection with worsening symptoms or imaging findings despite medication
- Any physical or psychological condition or exam finding that the investigator believes makes participation unsafe or unsuitable
AI-Screening
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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.
CONTACT
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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