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Comparing Post-Transplant Cyclophosphamide As GVHD Prophylaxis to Standard of Care for Acute Leukemia Patients | Clinical Trials | Clareo Health

RECRUITINGPHASE3

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

NCT04314219•King Faisal Specialist Hospital & Research Center

View on ClinicalTrials.gov

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.

Eligibility

Age

14 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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
•Estimated creatinine clearance greater than 50 mL/minute
•Pulmonary function: DLCO ≥ 50% (adjusted for hemoglobin), and FVC and FEV1 ≥ 50%
•Liver function: total bilirubin \< 2x the upper limit of normal (unless elevated bilirubin is attributed to Gilbert's Syndrome) and ALT/AST \< 2.5x the upper normal limit
•Signed informed consent

Exclusion Criteria

•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
•Patients seropositive for HIV-1 or -2
•Patients seropositive for HTLV-I or -II
•Patients with active Hepatitis B or C viral replication by PCR
•Women who are pregnant (positive serum or urine βHCG) or breastfeeding
•Females with childbearing potential (FCBP) or men who have sexual contact with FCBP unwilling to use effective forms of birth control or abstinence for one year after transplantation
•History of uncontrolled autoimmune disease or on active treatment
+1 more criteria

Locations (1)

King Faisal Specialist Hospital & Research Center

Riyadh, Saudi Arabia

Key Dates

Start Date

August 15, 2021

Primary Completion Date

December 1, 2025

Completion Date

December 1, 2026

Last Updated

March 13, 2025

Enrollment

264

ESTIMATED participants

Conditions

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

Interventions

Cyclophosphamide 50mg

DRUG

Methotrexate

DRUG

Contacts

Riad O El Fakih, MD

CONTACT

+ 966114647272 relfakih1@kfshrc.edu.sa

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Acute Myeloid Leukemia (AML) in Remission

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 13, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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