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

Launched by KING FAISAL SPECIALIST HOSPITAL & RESEARCH CENTER · Mar 17, 2020

Keywords

ClinConnect Summary

This clinical trial is studying two different methods to help prevent graft-versus-host disease (GVHD) in patients who have received a stem cell transplant due to acute leukemia, specifically Acute Lymphoblastic Leukemia (ALL) or Acute Myeloid Leukemia (AML) that is in remission. The trial will compare the standard treatment, which includes medications like methotrexate and calcineurin inhibitors, to a new approach using a drug called cyclophosphamide along with calcineurin inhibitors. The goal is to see which method is more effective in keeping patients healthy after their transplant.

To participate in this trial, patients need to be between the ages of 13 and 40 and must have a fully matched donor ready to provide stem cells. They should be in complete remission from their leukemia and meet specific health criteria, such as having good heart, lung, and liver function. Participants will receive either of the two treatments and will be monitored closely throughout the study. It's important to note that individuals with certain health conditions, active infections, or specific cancers may not be eligible. By joining this trial, participants may contribute to advancing treatment options for future patients facing similar challenges.

Gender

ALL

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.