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Reduced ATG Plus Mini PTCy for GVHD Prophylaxis in Haplo-SCT

StatusRecruiting
PhasePhase 2
Started2025-05-21
View on ClinicalTrials.gov ↗
Record status
This record was last updated July 25, 2025 (before its estimated July 31, 2025 completion). Its status may not reflect the trial's current state.

Amendment history

2025-07-22
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-05-22→confirmed 2025-05-21
Study sitesdetails revised at 1 of 1 site
2025-05-21
minor
Original filing
Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is regarded as a curative therapy for a variety of hematological malignancies and nonmalignant diseases. However, donor limitations have restricted the widespread use of allo-HSCT for a long period. The development and success of haploidentical allografts worldwide makes "everyone has a donor" a reality. In the past two decades, researchers have established several haploidentical HSCT (haplo-HSCT) protocols based on different approaches to induce immune tolerance. The representative approaches for haplo-HSCT without in vitro. T cell depletion include granulocyte colony-stimulating factor (G-CSF) plus Anti-human Thymocyte Immunoglobulin (ATG) based (Beijing Protocol) and post-transplantation cyclophosphamide based (PT-Cy, Baltimore Protocol) protocols. Both of two protocols have common problems that need to be solved, including infection transplantation related mortality and disease relapse. The main aim of this study is to explore whether the combined protocol can improve the efficacy of haploidentical transplantation further.
Trial Details
NCT Number NCT06984536
Lead Sponsor Peking University People's Hospital
Conditions Myelodysplastic Syndrome, Acute Leukemia
Enrollment 40 participants
Start Date 2025-05-21
Primary Completion 2025-07-31 (estimated)
Study Completion 2026-07-31 (estimated)
Updated on ClinicalTrials.gov 2025-07-25