Status:
RECRUITING
A First-in-Human Study of HLA-Partially to Fully Matched Allogenic Cryopreserved Deceased Donor Bone Marrow Transplantation for Patients With Hematologic Malignancies
Lead Sponsor:
Ossium Health, Inc.
Conditions:
Acute Leukemia
Acute Lymphoblastic Leukemia
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief 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, myelodyspl...
Eligibility Criteria
Inclusion Criteria:
-
Patient has the ability to provide informed consent according to the applicable regulatory and local institutional requirements
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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)
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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
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Stated willingness to comply with all study procedures and availability for the duration of the study
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Diagnosed with malignant hematologic disease including:
- 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
- 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)
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HCT comorbidity index (HCT-CI) ≤5
-
Adequate organ function defined as:
- Cardiac: LVEF at rest ≥40% (RIC) or LVEF at rest ≥45% (MAC)
- Pulmonary: DLCO, FEV1, FVC ≥50% predicted by pulmonary function tests (PFTs). DLCO value may be corrected for hemoglobin.
- 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
- 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
Key Trial Info
Start Date :
August 16 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2027
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT05589896
Start Date
August 16 2024
End Date
March 31 2027
Last Update
February 24 2026
Active Locations (9)
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1
City of Hope
Duarte, California, United States, 91010
2
Moffitt Cancer Center
Tampa, Florida, United States, 33612
3
Emory University - Winship Cancer Institute
Atlanta, Georgia, United States, 30322
4
Henry Ford Cancer Institute
Detroit, Michigan, United States, 48202