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

Study acronym: OPTIMIZE
StatusActive, Not Recruiting
PhasePhase 2
Started2023-12-08
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 10 months later Feb 1, 2026 → Dec 24, 2026
See other at-risk trials from Center for International Blood and Marrow Transplant Research

Amendment history

2026-08-14
Study Status, Contacts/Locations v14
Primary completion pushed: 2026-02-01 → 2026-12-24
Completion pushed: 2026-06-30 → 2026-12-30
2026-02-03
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v13
Trial statusRecruiting→Active, Not Recruiting
Study sitesdetails revised at 32 of 32 sites
2025-05-27
Study Status, Study Design, Contacts/Locations v12
Enrollment target190→313
Study sites28→32
2025-03-31
Study Identification, Study Status, Contacts/Locations v11
Study sites24→28
Study titlerevised
HLA-Mismatched Unrelated Donor Peripheral Blood Stem Cell Transplantation withWith Reduced Dose Post Transplantation Cyclophosphamide GvHD Prophylaxis
2024-11-25
Study Status, Contacts/Locations v10
Study sites23→24
Show 9 earlier versions
2024-10-21
Study Identification, Study Status, Contacts/Locations v9
Study sites21→23
Study titlerevised
HLA-Mismatched Unrelated Donor Peripheral Blood Stem Cell Transplantation Withwith Reduced Dose Post Transplantation Cyclophosphamide GvHD Prophylaxis
2024-08-26
Study Status, Contacts/Locations v8
Study sites17→21
2024-07-15
Study Status, Contacts/Locations v7
Study sitesdetails revised at 1 of 17 sites
2024-06-10
Study Status, Contacts/Locations v6
Study sitescontacts updated at 3 of 17 sites
2024-06-04
Study Status, Contacts/Locations v5
Study sites16→17
2024-04-08
Study Status, Contacts/Locations v4
Study sitesdetails revised at 2 of 16 sites
2024-03-12
Study Status, Contacts/Locations v3
Study sites10→16
2024-02-05
Study Status, Study Design, Arms and Interventions, Contacts/Locations v2
Enrollment target170→190
Study sites8→10
2024-01-03
Not Yet Recruiting→Recruiting Study Status, Oversight, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2023-11-01→confirmed 2023-12-08
Study sites6→8
2023-08-14
Original filing
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?
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 2026-12-24 (estimated)
Study Completion 2026-12-30 (estimated)
Updated on ClinicalTrials.gov 2026-08-17