Status:
RECRUITING
Comparing Post-Transplant Cyclophosphamide As GVHD Prophylaxis to Standard of Care for Acute Leukemia Patients
Lead Sponsor:
King Faisal Specialist Hospital & Research Center
Conditions:
Acute Lymphoblastic Leukemia (ALL) in Complete Remission
Acute Myeloid Leukemia (AML) in Remission
Eligibility:
All Genders
14-65 years
Phase:
PHASE3
Brief 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 cyclophosphamid...
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 m...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
264 Patients enrolled
Trial Details
Trial ID
NCT04314219
Start Date
August 15 2021
End Date
December 1 2026
Last Update
March 13 2025
Active Locations (1)
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1
King Faisal Specialist Hospital & Research Center
Riyadh, Saudi Arabia