drugset / Trial / NCT04314219

Comparing Post-Transplant Cyclophosphamide As GVHD Prophylaxis to Standard of Care for Acute Leukemia Patients

NCT04314219 ↗

Phase 3 Recruiting 264 enrolled King Faisal Specialist Hospital & Research Center
RandomizedParallel-groupOpen-labelPrevention

Summary

This randomized clinical trial will evaluate two approaches of GvHD prophylaxis; the standard of care GVHD prophylaxis regimen (methotrexate/calcineurin inhibitors) and post-transplant cyclophosphamide with calcineurin inhibitors for their efficacy as a new GVHD prophylaxis strategy.

Timeline

Start
2021-08-15
Primary completion
2025-12
Completion
2026-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Cyclophosphamide Other / unclassified 50 mg/kg Intravenous
Comparator Methotrexate Small molecule — —