A Randomized Study to Compare Post-transplant Cyclophosphamide, Sirolimus, Ruxolitinib and Post-transplant Cyclophosphamide, Sirolimus, Mycophenolate Mofetil to Prevent Graft Versus Host Disease
M.D. Anderson Cancer Center
Summary
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.
Description
Primary Objective: To compare Grade 2-4 acute graft versus host disease-free survival (GFS) between the MMF and Ruxolitinib arms Secondary Objectives: To compare the following between treatment arms: 1. Grade 3-5 adverse event of this regimen as per CTCAE v5.0 criteria. 2. Graft versus host disease-free, relapse-free survival (GRFS) 3. Time to neutrophil and platelet engraftment 4. Incidence of acute and chronic GVHD 5. Relapse incidence 6. Non relapse mortality 7. Overall survival 8. Progression-free survival 9. Chimerism 10. Immunosuppression cessation time 11. Rate of graft failure Exp…
Eligibility
- Age range
- 65–75 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Age ≥ 65 and \< 75 years are eligible if they have one of the following diseases. 1. Acute Myeloid Leukemia 2. Myelodysplastic syndrome 3. Chronic myelomonocytic leukemia 2. Available HLA-identical or haploidentical related donor or a 7/8 or 8/8 HLA matched unrelated donor. 3. Peripheral blood stem cells as a graft source 4. Subject must voluntarily sign an informed consent. 5. Adequate organ function per local laboratory reference range as follows: - Aspartate transaminase (AST) and alanine transaminase (ALT) \< 3.0X ULN - Total Bilirubin \<1.5 x ULN (unless…
Interventions
- DrugMycophenolate Mofetil
15 mg/kg/dose (max: 1,000mg/dose) IV/PO three times daily
- DrugRuxolitinib
5 mg PO every 12 hours
Location
- The University of Texas M. D. Anderson Cancer CenterHouston, Texas