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A First-in-Human Study of HLA-Partially to Fully Matched Allogenic Cryopreserved Deceased Donor Bone Marrow Transplantation for Patients With Hematologic Malignancies

StatusActive, Not Recruiting
PhasePhase 1/2
Started2024-08-16
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 44 days later May 31, 2026 → Jul 14, 2026
See other at-risk trials from Ossium Health, Inc.

Amendment history

2026-09-08
Study Identification, Study Status v7
Re-verified, no change to tracked fields
2026-07-16
Study Status, Contacts/Locations v6
Trial status changed: Recruiting → Active, Not Recruiting
Primary completion pushed: 2026-05-31 → 2026-07-14
Completion pushed: 2027-03-31 → 2029-05-31
Study sitesdetails revised at 9 of 9 sites
2026-02-20
Study Status, Sponsor/Collaborators, Contacts/Locations v5
Primary completion date2026-02-25→2026-05-31
Completion date2026-12-31→2027-03-31
Study sites9 entries, revised
ColumbiaEmory University - Herbert Irving ComprehensiveWinship Cancer CenterInstitute
Collaborators-61 characters
Center for International Blood and Marrow Transplant Research
2025-06-23
Study Status, Oversight v4
Primary completion date2026-08→2026-02-25
Completion date2027-11→2026-12-31
2025-03-24
Study Status, Oversight, Study Description, Conditions, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v3
Primary completion date2025-08→2026-08
Completion date2025-08→2027-11
Start dateestimated 2024-03-30→confirmed 2024-08-16
Study sites4→9
Eligibility criteria+291 characters
[...] cal institutional requirements Male or female, aged ≥18 and <55≤65 years for patients receiving MAC (Regimen A or Regimen B); aged ≥18 and <70≤75 years for patients receiving RIC (Regimen C inor Cohort 2 onlyD) Patient must require allogeneic HCT per the discretion of [...] d availability for the duration of the study Diagnosed with acutemalignant hematologic disease including: Acute leukemia [acute lymphoblastic leukemia (ALL), acute myeloid [...] ic leukemia (ABL), or acute undifferentiated leukemia (AUL)], MDS without fibrosis, or chronic leukemia (CLL, CML) in the first remission or beyond with ≤5% mar [...] [...]
Primary endpoints5 entries, revised
CTCAE Grade 3/4 Adverse Events (AEs) attributed to infusion of Ossium HPC, Marrow
Show 2 earlier versions
2024-02-14
Study Status, Arms and Interventions, Contacts/Locations v2
Completion date2025-12→2025-08
Start date2023-11-30→2024-03-30
Study sites2→4
Study arms3→2
InterventionsBone Marrow Transplant (Procedure), Busulfan (Drug), Cyclophosphamide (Drug), Cyclophosphamide (Drug), Filgrastim (Drug), Fludarabine…→Ossium HPC Marrow, Bone Marrow Transplant (Other), Post-transplant treatment (Other), Pre-transplant conditioning - Myeloablative (MAC)…
2023-11-21
Not Yet Recruiting→Recruiting Study Status, Outcome Measures, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2025-03→2025-08
Start date2023-03→2023-11-30
Study sites0→2
Primary endpoints5 entries, revised
CTCAE Grade 3/4 orAdverse higherEvents infusion-related toxicity(AEs)
2022-10-18
Original filing
Ossium Health, Inc.
4 trials monitored
See 1 trial at risk
Leukemia
2,553 trials monitored
See 134 trials at risk
Non-Hodgkin Lymphoma
1,512 trials monitored
See 79 trials at risk
Acute Myeloid Leukemia (AML)
1,196 trials monitored
See 63 trials at risk
and 5 more diseases
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.
Trial Details
NCT Number NCT05589896
Lead Sponsor Ossium Health, Inc.
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) +3 more
Enrollment 12 participants
Start Date 2024-08-16
Primary Completion 2026-07-14 (estimated)
Study Completion 2029-05-31 (estimated)
Updated on ClinicalTrials.gov 2026-09-10