Actively Recruiting
A Randomized Study Comparing 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 2026-05-20
80
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating two drug combinations to prevent graft versus host disease (GVHD) after stem cell transplant in patients aged 65 to 75 years with certain blood cancers including acute myeloid leukemia, myelodysplastic syndrome, or chronic myelomonocytic leukemia. The study aims to compare how well the combinations work and their safety, focusing on acute GVHD-free survival and other important health outcomes. It is a phase 2 randomized study sponsored by M.D. Anderson Cancer Center. The study compares two treatment groups: one receiving post-transplant cyclophosphamide, sirolimus, and mycophenolate mofetil taken three times daily by IV or orally, and the other receiving post-transplant cyclophosphamide, sirolimus, and ruxolitinib taken orally every 12 hours. Both treatments are given after stem cell transplant and participants receive peripheral blood stem cells from a matched or haploidentical donor. The study monitors these treatments for one year to evaluate their effects on GVHD prevention and other outcomes. Participants will be closely monitored throughout the study with assessments of adverse events, blood counts, organ function, and immune recovery. Researchers will measure several outcomes including survival without GVHD, time to blood cell recovery, incidence of relapse, and overall survival. Safety is tracked through adverse event reporting during the approximately one-year study period. Participants must provide informed consent and meet specific health criteria to join the study.
CONDITIONS
Brief 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
- Diagnosis of acute myeloid leukemia, myelodysplastic syndrome, or chronic myelomonocytic leukemia
- Availability of HLA-identical or haploidentical related donor or 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 upper limit normal, total bilirubin less than 1.5 times upper limit normal (exceptions apply)
- Creatinine clearance at least 40 mL/min/1.73 m2
- Lung diffusion capacity corrected for hemoglobin at least 50% of predicted
- Ejection fraction at least 50%
- Agreement to use effective contraception for men and women of child-bearing potential during and after study participation
You will not qualify if you...
- Positive for HIV infection
- Diagnosis of acute promyelocytic leukemia
- Active central nervous system involvement with AML
- Hematopoietic Cell Transplantation Comorbidity Index score greater than 5
- Uncontrolled or active infections including viral, bacterial, or fungal
- Chronic hepatitis B or C requiring treatment (with some exceptions for prior vaccination or inactive infection)
- History of congestive heart failure requiring treatment or ejection fraction below 50%
- Recent major cardiac events such as myocardial infarction, stroke, pulmonary embolism, or deep vein thrombosis
- Current or history of active tuberculosis
- White blood cell count above 25 x 10^9/L
- Pregnancy or breastfeeding due to potential risks to fetus or infant
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 year
Participants receive post-transplant cyclophosphamide, sirolimus, and are randomized to receive either mycophenolate mofetil or ruxolitinib to prevent graft versus host disease.
Regular visits throughout treatment period
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
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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