A Multi-Center Biologic Assignment Trial Comparing Allogeneic Hematopoietic Cell Transplant to Hypomethylating Therapy or Best Supportive Care in Patients w/Intermediate-2 & High Risk Myelodysplastic Syndrome (BMT CTN #1102)
The primary purpose of this study is to compare standard treatments to reduced intensity allogeneic transplants for the treatment of myelodysplastic syndromes (MDS).
Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.
- Laura Johnston, MD
- Robert Negrin, M.D.
- Wen-Kai Weng, MD, PhD
- Robert Lowsky, MD
- Ginna G. Laport
- Judith Shizuru, Ph.D., M.D.
- procedure : Allogeneic Hematopoietic Cell Transplant
- procedure : Hypomethylating Therapy / Best Supportive Care
Phase: Phase 2
Ages Eligible For Study:
- Patients fulfilling the following criteria will be eligible for entry into this study: 1. Patients with de novo MDS who have, or have previously had, Intermediate-2 or High risk disease as determined by the International Prognostic Scoring System (IPSS). Current Intermediate-2 or High risk disease is NOT a requirement. 2. Patients must have an acceptable MDS subtype: - Refractory cytopenia with unilineage dysplasia (RCUD) (includes refractory anemia (RA)) - Refractory anemia with ringed sideroblasts (RARS) - Refractory anemia with excess blasts (RAEB-1) - Refractory anemia with excess blasts (RAEB-2) - Refractory cytopenia with multilineage dysplasia (RCMD) - Myelodysplastic syndrome with isolated del(5q) (5q-syndrome) - Myelodysplastic syndrome (MDS), unclassifiable 3. Patients must have fewer than 20% marrow blasts within 60 days of consent. 4. Patients may have received prior therapy for the treatment of MDS, including but not limited to: growth factor, transfusion support, immunomodulatory (IMID) therapy, DNA hypomethylating therapy, or cytotoxic chemotherapy prior to enrollment. 5. Age 50.0-75.0 years. 6. Karnofsky performance status > 70 or Eastern Cooperative Oncology Group (ECOG) ? 1. 7. Patients are eligible if no formal unrelated donor search has been activated prior to date of consent. A formal unrelated donor search begins at the time at which samples are requested from potential National Marrow Donor Program (NMDP) donors. Patients who have started a sibling donor search or who have found a matched sibling donor are eligible. 8. Patients and physicians must be willing to comply with treatment assignment: 1. No intent to proceed with alloHCT using donor sources not specified in this protocol, including human leukocyte antigen (HLA)-mismatched related or unrelated donors (< 6/6 HLA related matched or < 8/8 HLA unrelated matched) or umbilical cord blood unit(s). 2. No intent to use myeloablative conditioning regimens. 3. Intent to proceed with RIC alloHCT if a matched sibling or matched unrelated donor is identified. There is no requirement as to the timing of the transplantation. 9. Patients must be considered to be suitable RIC alloHCT candidates at the time of enrollment based on medical history, physical examination, and available laboratory tests. Specific testing for organ function is not required for eligibility but, if available, these tests should be used to judge eligibility. 10. Signed informed consent