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

NCT04314219 · King Faisal Specialist Hospital & Research Center
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Official title
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
About this study
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 criteria
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 * Patients with prior malignancies, except resected non-melanoma skin cancer or treated cervical carcinoma in situ; cancer treated with curative intent ≥ 5 years previously will be allowed; cancer treated with curative intent \< 5 years previously will not be allowed.
Study design
Enrollment target: 264 participants
Allocation: randomized
Masking: none
Age groups: child, adult, older_adult
Timeline
Starts: 2021-08-15
Estimated completion: 2026-12
Last updated: 2025-03-13
Interventions
Drug: Cyclophosphamide 50mgDrug: Methotrexate
Primary outcomes
  • GRFS (GVHD-free/relapse-free survival) (One-year post-transplant)
Sponsor
King Faisal Specialist Hospital & Research Center · other
Contacts & investigators
ContactRiad O El Fakih, MD · contact · relfakih1@kfshrc.edu.sa · + 966114647272
InvestigatorRiad O El Fakih, MD · principal_investigator, KFSH&RC
InvestigatorMahmoud D Aljurf, MD, MPH · principal_investigator, KFSH&RC
InvestigatorMarwan Y Shaheen, MD · principal_investigator, KFSH&RC
All locations (1)
King Faisal Specialist Hospital & Research CenterRecruiting
Riyadh, Saudi Arabia
Comparing Post-Transplant Cyclophosphamide As GVHD Prophylaxis to Standard of Care for Acute Leukemia Patients · TrialPath