NCT04314219

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

Comparing Post-Transplant Cyclophosphamide with Calcineurin Inhibitors As a GVHD Prophylaxis to Standard Care of Methotrexate and Calcineurin Inhibitors for Acute Leukemia Incorporating Patient Pharmacogenomics Profiling

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 264 (estimated)
• Sponsor: King Faisal Specialist Hospital & Research Center · Academic / Other
• Sex: All
• Age: 14 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

An open-label randomized clinical trial will be performed. Eligible patients are females and males, between 14 and 65 years undergoing allo-HCT for treatment of Acute Leukemia (AML or ALL). Patients must have a matching related peripheral blood stem cell donor. Patients from or referred to the KFSH\&RC for allogeneic transplant consideration will be offered the opportunity to participate in this trial. Treatment Description: Patients will be randomized on one of the arms; an intervention or a standard of care arm.

Conditions

• Acute Lymphoblastic Leukemia (ALL) in Complete Remission
• Acute Myeloid Leukemia (AML) in Remission

Interventions

Type	Name	Description
DRUG	Cyclophosphamide 50mg	Cyclophosphamide as GVHD prophylaxis will be on day +3 and day +5
DRUG	Methotrexate	Methotrexate as GVHD prophylaxis will be on day +1, day +3, and day +6

Timeline

• Start date: 2021-08-15
• Primary completion: 2025-12-01
• Completion: 2026-12-01
• First posted: 2020-03-19
• Last updated: 2025-03-13

Locations

1 site across 1 country: Saudi Arabia