Who is sponsoring NCT05170828?

NCT05170828 is sponsored by Ossium Health, Inc..

What condition does NCT05170828 study?

NCT05170828 studies Acute Leukemia, Myelodysplastic Syndromes, T-lymphoblastic Lymphoma, Acute Lymphocytic Leukemia, Acute Myeloid Leukemia, Acute Biphenotypic Leukemia, Acute Undifferentiated Leukemia.

What drugs are being tested in NCT05170828?

Interventions: Cyclophosphamide, Fludarabine, Total Body Irradiation, Busulfan, Mesna, Sirolimus, Mycophenolate Mofetil, Filgrastim, Cyclophosphamide, Bone Marrow Transplant.

What is the status of NCT05170828?

NCT05170828 is currently WITHDRAWN.

Last reviewed 2026-02-20 · How we verify

PRESERVE: A Multi-Center Trial Using Banked, Cryopreserved HLA-Mismatched Unrelated Donor Bone Marrow and Post-Transplantation Cyclophosphamide in Allogeneic Transplantation for Patients With Hematologic Malignancies

NCT05170828 Phase 1 WITHDRAWN

Multicenter single arm study to assess the safety and efficacy of allogeneic transplantation using cryopreserved bone marrow from deceased MMUD and PTCy, sirolimus and MMF for GVHD prophylaxis.

Details

Lead sponsor	Ossium Health, Inc.
Phase	Phase 1
Status	WITHDRAWN
Start date	2022-09
Completion	2024-11

Conditions

Acute Leukemia
Myelodysplastic Syndromes
T-lymphoblastic Lymphoma
Acute Lymphocytic Leukemia
Acute Myeloid Leukemia
Acute Biphenotypic Leukemia
Acute Undifferentiated Leukemia

Interventions

Cyclophosphamide
Fludarabine
Total Body Irradiation
Busulfan
Mesna
Sirolimus
Mycophenolate Mofetil
Filgrastim
Cyclophosphamide
Bone Marrow Transplant

Primary outcomes

Neutrophil engraftment — Day 35 Post HCT
Run-in safety phase primary endpoint; Neutrophil engraftment is defined as neutrophil recovery by Day 35. Neutrophil recovery is defined as donor-derived absolute neutrophil count (ANC) ≥ 500/mm3 for three consecutive days with evidence of donor chimerism in bone marrow or peripheral blood. Full donor chimerism is \>95%, and mixed donor chimerism is defined as 5-95%.
Cumulative incidence and kinetics of neutrophil and platelet recovery — Day 35 Post HCT
Main phase primary endpoint; Neutrophil recovery is defined as achieving an absolute neutrophil count (ANC) greater than or equal to 500/mm3 for three consecutive measurements on three different days. The first of the three days will be designated the day of neutrophil recovery. The competing event is death without neutrophil recovery. For subjects who never drop ANC below 500/mm3, the date of neutrophil recovery will be Day 1 post-transplant. Platelet recovery is defined by two different metrics: the first day of a sustained platelet count greater than or equal to 20,000/mm3 or greater than or equal to 50,000/mm3 with no platelet transfusions in the preceding seven days. The first day of sustained platelet count above these thresholds will be designated the day of platelet engraftment. For subjects who never drop their platelet count below 20,000/mm3, the date of platelet recovery will be Day 1 post HCT.
Overall survival (OS) — 1-year Post HCT
Main phase primary endpoint; The primary endpoint for the study is OS at 1-year post-HCT. The event is death from any cause. The time to this event is the time from HCT to death, loss to follow-up, or end of study (whichever comes first). Subjects who are lost to follow-up prior to 1-year will be censored at the time of the last observation, and the OS probability will be estimated using the Kaplan-Meier method.