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

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

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

Inclusion Criteria8

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 Criteria11

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.