Comparing two methods to prevent GVHD in leukemia patients after transplant

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of post-transplant cyclophosphamide compared to the standard GVHD prophylaxis regimen in patients with acute leukemia who are in complete remission. It is a randomized, open-label trial involving patients aged 14 to 65 years undergoing allogeneic hematopoietic cell transplantation with a matched sibling donor. Participants will be assigned to either the intervention group receiving cyclophosphamide or the control group receiving standard care. The study aims to determine which approach better prevents graft-versus-host disease (GVHD).

Why it matters

Who can join: the full rules

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.

Where it's running

• King Faisal Specialist Hospital & Research Center
  Riyadh, Saudi Arabia Recruiting

Study contacts

• Principal investigator: Riad O El Fakih, MD — Kfsh&rc
• Study coordinator: Riad O El Fakih, MD
• Email: relfakih1@kfshrc.edu.sa
• Phone: + 966114647272

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.