Actively Recruiting
A Randomized Study to Compare Post-transplant Cyclophosphamide, Sirolimus, Ruxolitinib and Post-transplant Cyclophosphamide, Sirolimus, Mycophenolate Mofetil to Prevent Graft Versus Host Disease
Led by M.D. Anderson Cancer Center · Updated on 2026-04-23
80
Participants Needed
1
Research Sites
236 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical research study is to compare the effects of these drug combinations (cyclophosphamide, sirolimus, and MMF vs cyclophosphamide, sirolimus, and ruxolitinib) on the prevention of GVHD after a stem cell transplant.
CONDITIONS
Official Title
A Randomized Study to Compare Post-transplant Cyclophosphamide, Sirolimus, Ruxolitinib and Post-transplant Cyclophosphamide, Sirolimus, Mycophenolate Mofetil to Prevent Graft Versus Host Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 65 to less than 75 years with diagnosis of acute myeloid leukemia, myelodysplastic syndrome, or chronic myelomonocytic leukemia
- Available HLA-identical or haploidentical related donor or a 7/8 or 8/8 HLA matched unrelated donor
- Peripheral blood stem cells as graft source
- Voluntary informed consent signed
- Adequate organ function: AST and ALT less than 3 times the upper limit of normal, total bilirubin less than 1.5 times upper limit (unless due to nonhepatic causes), creatinine clearance at least 40 mL/min/1.73 m2
- Lung function (DLCO corrected for hemoglobin) at least 50% predicted
- Ejection fraction of 50% or higher
- Agree to use adequate contraception if of child-bearing potential or partner of such a person
You will not qualify if you...
- Known HIV positive status
- Diagnosis of acute promyelocytic leukemia
- Active central nervous system involvement with AML
- Hematopoietic Cell Transplantation Comorbidity Index score over 5
- Uncontrolled or active systemic infection
- Chronic hepatitis B or C requiring treatment (except certain serologic profiles)
- History of congestive heart failure requiring treatment, ejection fraction less than 50%, unstable angina, or myocardial infarction within 1 year
- Major adverse cardiac events such as myocardial infarction, stroke, pulmonary embolism, or deep vein thrombosis within 6 months
- Current or history of active tuberculosis
- White blood cell count over 25 x 10^9/L
- Pregnancy or breastfeeding due to unknown risks of study agents
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The University of Texas M. D. Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
U
Uday Popat, MBA,MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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