Compares two drug plans to prevent graft-versus-host disease after transplant in acute leukemia
Tests cyclophosphamide with calcineurin inhibitors against standard drugs in people with acute leukemia.
Plain-language title generated from the registry record
Registry title: Comparing Post-Transplant Cyclophosphamide As GVHD Prophylaxis to Standard of Care for Acute Leukemia Patients
Key facts
- Where
- Riyadh, Saudi ArabiaSee the site
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 14 and 65 years old?
Source: NCT04314219, who can take part
Where in Saudi Arabia
- King Faisal Specialist Hospital & Research CenterRiyadh, Saudi ArabiaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- King Faisal Specialist Hospital & Research Center
- Trial code
- NCT04314219
- Record updated
- 13 March 2025
- Original description
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.Read full original descriptionShow less
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
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.
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: 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; Active disease; Patients with uncontrolled bacterial, viral, or fungal infections; Patients seropositive for HIV-1 or -2; Patients with active Hepatitis B or C viral replication by PCR; History of uncontrolled autoimmune disease or on active treatment; Presence of fluid collection (ascites, pleural or pericardial effusion) that interferes with methotrexate clearance or makes methotrexate use contraindicated; Women who are pregnant (positive serum or urine βHCG) or breastfeeding; 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; Karnofsky or Lansky Performance Score < 70%; Patients seropositive for HTLV-I or -II.