Allo vs. Hypomethylating/Best Supportive Care in MDS (Blood and Marrow Transplant Clinical Trials Network #1102)
Diagnosis: Hematopoietic Stem Cell Transplant
NCT ID: NCT02016781
(View complete trial on ClinicalTrials.gov)
DFCI Protocol ID:
This study is designed as a multicenter trial, with biological assignment to one of two study arms; Arm 1: Reduced intensity conditioning allogeneic hematopoietic cell transplantation (RIC-alloHCT), Arm 2: Non-Transplant Therapy/Best Supportive Care.
Brigham and Women's Hospital, Dana-Farber Cancer Institute
Corey Cutler, MD,
Dana-Farber Cancer Institute
Dana-Farber Cancer Institute:
- Patients fulfilling the following criteria will be eligible for entry into this
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 fewer than 20% marrow blasts at the time (within 30 days) of
registration and consent.
3. 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 trial
4. Age 50.0-75.0 years.
5. Karnofsky performance status > 70 or Eastern Cooperative Oncology Group (ECOG) ≤
1 (see comparison scale in Appendix D).
6. Patients are eligible if no formal unrelated donor search has been activated
prior to enrollment. Patients who have started a sibling donor search or who
have found a matched sibling donor are eligible.
7. 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
8. 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.
9. Signed informed consent
- Patients with the following will be ineligible for registration onto this study:
1. Therapy-related MDS
2. Current or prior diagnosis of AML
3. Uncontrolled bacterial, viral or fungal infection
4. Concurrent malignancy other than superficial squamous cell or basal cell
carcinoma of the skin
5. Prior autologous or allogeneic HCT
6. Human Immunodeficiency Virus (HIV) infection
7. Fertile patients unwilling to use contraceptive techniques
8. Patients with psychosocial conditions that would prevent study compliance