NCT05170828

Cryopreserved MMUD BM With PTCy for Hematologic Malignancies

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

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Ossium Health, Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

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

Interventions

Type	Name	Description
DRUG	Cyclophosphamide	pre-transplant conditioning treatment
DRUG	Fludarabine	pre-transplant conditioning treatment
RADIATION	Total Body Irradiation	pre-transplant conditioning treatment
DRUG	Busulfan	pre-transplant conditioning treatment
DRUG	Mesna	given with cyclophosphamide
DRUG	Sirolimus	post-transplant treatment for GVHD
DRUG	Mycophenolate Mofetil	post-transplant treatment for GVHD
DRUG	Filgrastim	post-transplant treatment for GVHD
DRUG	Cyclophosphamide	post-transplant treatment for GVHD
PROCEDURE	Bone Marrow Transplant	Transplant with investigational bone marrow product

Timeline

• Start date: 2022-09-01
• Primary completion: 2024-03-01
• Completion: 2024-11-01
• First posted: 2021-12-28
• Last updated: 2026-02-24

Regulatory

• FDA-regulated drug study