Clinical Trial

HLA-Mismatched Unrelated Donor Peripheral Blood Stem Cell Transplantation With Reduced Dose Post Transplantation Cyclophosphamide GvHD Prophylaxis

Study acronym: OPTIMIZE
Active, Not Recruiting Phase 2
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Summary
The goal of this clinical trial is to determine the effectiveness of Reduced Dose Post-Transplant Cyclophosphamide (PTCy) in patients with hematologic malignancies after receiving an HLA-Mismatched Unrelated Donor (MMUD) . The main question\[s\] it aims to answer are: * Does a reduced dose of PTCy reduce the occurrence of infections in the first 100 days after transplant? * Does a reduced dose of PTCy maintain the same level of protection against Graft Versus Host Disease (GvHD) as the standard dose of PTCy?
Protocol Amendment History 13 amendments
This ClinicalTrials.gov record has been amended 13 times since 2023-08-14; most recent amendment 2026-02-03.
Status change: Recruiting → Active, Not Recruiting 2026-02-03
Status change: Not Yet Recruiting → Recruiting 2024-01-03
Trial Details
NCT Number NCT06001385
Lead Sponsor Center for International Blood and Marrow Transplant Research
Collaborators: National Marrow Donor Program
Conditions Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Acute Leukemia, Myelodysplastic Syndromes, Chronic Myeloid Leukemia, Chronic Lymphocytic Leukemia, Myeloproliferative Neoplasm, Lymphoma +3 more
Enrollment 313 participants
Start Date 2023-12-08
Primary Completion 2026-02-01 (estimated)
Study Completion 2026-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-02-05