RecruitingPhase 3NCT04314219

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


Sponsor

King Faisal Specialist Hospital & Research Center

Enrollment

264 participants

Start Date

Aug 15, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 14 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two approaches to preventing graft-versus-host disease (GVHD — a serious complication where donor immune cells attack the recipient's body) in patients with acute leukemia receiving a stem cell transplant from a matched family donor. **You may be eligible if...** - You have acute leukemia (AML or ALL) that is in complete remission - You have a fully matched related donor (8 out of 8 markers matched) willing to donate stem cells - Your heart, lungs, kidneys, and liver function are within required ranges - You are planned to receive a high-intensity (myeloablative) conditioning regimen before transplant **You may NOT be eligible if...** - Your leukemia is still active at the time of transplant - You have uncontrolled infections (bacterial, viral, or fungal) - Your overall physical condition is significantly impaired (Karnofsky/Lansky score below 70%) - You have previously received a stem cell transplant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCyclophosphamide 50mg

Cyclophosphamide as GVHD prophylaxis will be on day +3 and day +5

DRUGMethotrexate

Methotrexate as GVHD prophylaxis will be on day +1, day +3, and day +6


Locations(1)

King Faisal Specialist Hospital & Research Center

Riyadh, Saudi Arabia

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NCT04314219


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