NCT04314219 Comparing Post-Transplant Cyclophosphamide As GVHD Prophylaxis to Standard of Care for Acute Leukemia Patients
| NCT ID | NCT04314219 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | King Faisal Specialist Hospital & Research Center |
| Condition | Acute Lymphoblastic Leukemia (ALL) in Complete Remission |
| Study Type | INTERVENTIONAL |
| Enrollment | 264 participants |
| Start Date | 2021-08-15 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 264 participants in total. It began in 2021-08-15 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 cyclophosphamide with calcineurin inhibitors for their efficacy as a new GVHD prophylaxis strategy.
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.
Contact & Investigator
Riad O El Fakih, MD
PRINCIPAL INVESTIGATOR
KFSH&RC
Frequently Asked Questions
Who can join the NCT04314219 clinical trial?
This trial is open to participants of all sexes, aged 14 Years or older, up to 65 Years, studying Acute Lymphoblastic Leukemia (ALL) in Complete Remission. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04314219 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 264 participants.
Is NCT04314219 currently recruiting?
Yes, NCT04314219 is actively recruiting participants. Contact the research team at relfakih1@kfshrc.edu.sa for enrollment information.
Where is the NCT04314219 trial being conducted?
This trial is being conducted at Riyadh, Saudi Arabia.
Who is sponsoring the NCT04314219 clinical trial?
NCT04314219 is sponsored by King Faisal Specialist Hospital & Research Center. The principal investigator is Riad O El Fakih, MD at KFSH&RC. The trial plans to enroll 264 participants.
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