Phase III Randomized Clinical Trial Comparing Post-Transplant Cyclophosphamide (PTCy) to Standard Care (SoC) for Acute Leukemia

• Status: Recruiting
• Trial end date: 2025-12-29
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: King Faisal Specialist Hospital & Research Center
• Treatments: Calcineurin Inhibitors; Cyclophosphamide; Methotrexate

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%2.

• 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.