Transplanting bone marrow from deceased donors for leukemia patients
A First-in-Human Study of HLA-Partially to Fully Matched Allogenic Cryopreserved Deceased Donor Bone Marrow Transplantation for Patients With Hematologic Malignancies
This study is testing if using bone marrow from deceased donors can be a safe and effective treatment for people with leukemia.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Ossium Health, Inc. Industry-sponsored |
| Locations | 9 sites (Duarte, California and 8 other locations) |
| Trial ID | NCT05589896 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the safety and feasibility of using allogeneic bone marrow from deceased donors for transplantation in patients with various types of acute and chronic leukemias. Participants will undergo either myeloablative or reduced intensity conditioning before receiving the transplant. The study will monitor patients for safety over a 56-day period and continue follow-up for one year to assess outcomes. The trial seeks to determine if this innovative approach can provide effective treatment options for patients with hematologic malignancies.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with high-resolution, HLA partially or fully matched bone marrow and diagnosed with specific types of leukemia or myelodysplastic syndrome.
Not a fit: Patients who do not have a suitable HLA match or those with advanced disease stages may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a new treatment option for patients with hematologic malignancies who lack suitable living donors.
How similar studies have performed: While the use of deceased donor bone marrow transplantation is a novel approach, similar studies have shown promise in related areas of hematologic treatment.
Eligibility criteria
Show full inclusion / exclusion 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 procedures and availability for the duration of the study * Diagnosed with malignant hematologic disease including: 1. Acute leukemia \[acute lymphoblastic leukemia (ALL), acute myeloid leukemia (AML), acute biophenotypic leukemia (ABL), or acute undifferentiated leukemia (AUL)\], MDS without fibrosis, or chronic leukemia (CLL, CML) in the first remission or beyond with ≤5% marrow blasts documented by bone marrow assessment and no circulating blasts or extra-medullary disease within 42 days prior to anticipated start of conditioning 2. Chemosensitive non-Hodgkin's lymphomas, Hodgkin's lymphoma, or cutaneous T cell lymphomas in the first remission or beyond documented by PET/CT imaging and bone marrow assessment within 42 days prior to anticipated start of conditioning * Karnofsky performance status score ≥70% (MAC) or ≥60% (RIC) * HCT comorbidity index (HCT-CI) ≤5 * Adequate organ function defined as: 1. Cardiac: LVEF at rest ≥40% (RIC) or LVEF at rest ≥45% (MAC) 2. Pulmonary: DLCO, FEV1, FVC ≥50% predicted by pulmonary function tests (PFTs). DLCO value may be corrected for hemoglobin. 3. Hepatic: total bilirubin ≤2.0 mg/dL, and ALT, AST, and ALP \<3 x upper limit normal (ULN), unless ALT, AST, and/or ALP are disease related 4. Renal: SCr within 1.5x normal range for age. If SCr is outside normal range for age, CrCl\> 60 mL/min/1.73m2 must be obtained (measured by 24-hour urine specimen or nuclear glomerular filtration rate (GFR), or calculated GFR) Exclusion Criteria: * Availability of suitable graft from living donor (defined as 7/8 or 8/8 HLA-matched related or unrelated donors, haploidentical donors, or cord blood donors) * Prior autologous or allogeneic HCT * Pregnancy or lactation * Ongoing treatment with an investigational drug used for disease-related treatment within 5 half-lives of the drug * Current uncontrolled bacterial, viral or fungal infection defined as currently taking medication with evidence of progression of clinical symptoms or radiologic findings * Any condition(s) or diagnosis, both physical or psychological, or physical exam finding that in the investigator's opinion precludes participation
Where this trial is running
Duarte, California and 8 other locations
- City of Hope — Duarte, California, United States (Recruiting)
- Moffitt Cancer Center — Tampa, Florida, United States (Recruiting)
- Emory University - Winship Cancer Institute — Atlanta, Georgia, United States (Recruiting)
- Henry Ford Cancer Institute — Detroit, Michigan, United States (Recruiting)
- Oregon Health and Science University — Portland, Oregon, United States (Recruiting)
- TriStar Bone Marrow Transplant — Nashville, Tennessee, United States (Recruiting)
- St. David's South Austin Medical Center — Austin, Texas, United States (Recruiting)
- Methodist Hospital, Texas Transplant — San Antonio, Texas, United States (Recruiting)
- University of Utah - Huntsman Cancer Institute — Salt Lake City, Utah, United States (Recruiting)
Study contacts
- Study coordinator: Preethi Prasad, M.Sc.
- Email: preethi.prasad@ossiumhealth.com
- Phone: 628-842-6562
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.