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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age14-65
SponsorKing Faisal Specialist Hospital & Research Center

About this trial

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.

Eligibility criteria

Qualifiers

Patients with Acute Leukemias (AML, ALL) in morphologic complete remission with or without hematologic recovery

Patients must have a fully matched (8/8) related donor willing to donate peripheral blood stem cells and must meet institutional criteria for donation

Planned Myeloablative conditioning regimen

Cardiac function: ejection fraction at rest ≥ 50% by MUGA or TTE

Disqualifiers

Karnofsky or Lansky Performance Score < 70%.

Active disease

Patients with uncontrolled bacterial, viral, or fungal infections

Presence of fluid collection (ascites, pleural or pericardial effusion) that interferes with methotrexate clearance or makes methotrexate use contraindicated

Trial design

Treatments tested in this trial

  • Cyclophosphamide 50mg
  • Methotrexate

Treatment groups

264 Participants
are divided into 2 treatment groups