M.D. Anderson Cancer Center
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.
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…
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…
15 mg/kg/dose (max: 1,000mg/dose) IV/PO three times daily
5 mg PO every 12 hours
Arctuva estimate
Verify or correct the compensation shown for this listing.