Actively Recruiting
Comparing Post-Transplant Cyclophosphamide As GVHD Prophylaxis to Standard of Care for Acute Leukemia Patients
Led by King Faisal Specialist Hospital & Research Center · Updated on 2025-03-13
264
Participants Needed
1
Research Sites
276 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Comparing Post-Transplant Cyclophosphamide As GVHD Prophylaxis to Standard of Care for Acute Leukemia Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with acute myeloid leukemia or acute lymphoblastic leukemia in complete remission
- Patients with a fully matched (8/8) related donor willing to donate peripheral blood stem cells
- Planned myeloablative conditioning regimen
- Cardiac ejection fraction at rest of 50% or higher measured by MUGA or TTE
- Estimated creatinine clearance greater than 50 mL/minute
- Pulmonary function with DLCO, FVC, and FEV1 at or above 50%
- Liver function with total bilirubin less than twice the upper limit of normal (unless due to Gilbert's Syndrome) and ALT/AST less than 2.5 times the upper limit
- Signed informed consent
You will not qualify if you...
- Karnofsky or Lansky Performance Score below 70%
- Active leukemia or active disease
- Uncontrolled bacterial, viral, or fungal infections
- Fluid collections interfering with methotrexate clearance or use
- Seropositive for HIV-1 or HIV-2
- Seropositive for HTLV-I or HTLV-II
- Active hepatitis B or C viral replication by PCR
- Pregnant or breastfeeding women
- Females with childbearing potential or men with sexual contact with such females unwilling to use effective birth control or abstinence for one year post-transplant
- History of uncontrolled autoimmune disease or on active treatment
- Prior malignancies except treated non-melanoma skin cancer or cervical carcinoma in situ; cancers treated with curative intent less than 5 years ago are not allowed
AI-Screening
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Trial Site Locations
Total: 1 location
1
King Faisal Specialist Hospital & Research Center
Riyadh, Saudi Arabia
Actively Recruiting
Research Team
R
Riad O El Fakih, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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