Allo vs Hypomethylating/Best Supportive Care in MDS (BMTCTN1102)

Completed · Phase 2

Conditions studied: MDS

In brief

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.

Key facts

Study ID: NCT02016781
Run by: Medical College of Wisconsin
People needed: 384
Starts: 2013-12-16
Expected to finish: 2021-10-05
Last updated by the study team: 2023-03-03

Who can join

Age: 50 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patients fulfilling the following criteria will be eligible for entry into this study:
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.
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
Patients must have fewer than 20% marrow blasts within 60 days of consent.
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.
Age 50.0-75.0 years.
Karnofsky performance status > 70 or Eastern Cooperative Oncology Group (ECOG) ≤ 1.
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.
Patients and physicians must be willing to comply with treatment assignment:
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).
No intent to use myeloablative conditioning regimens.
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.
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.
Signed informed consent

You may not qualify if…

Patients with the following will be ineligible for registration onto this study:
Therapy-related MDS (defined as the occurrence of MDS due to prior exposure to systemic chemotherapy and/or radiation for malignancy)
Current or prior diagnosis of AML
Chronic myelomonocytic leukemia or myelodysplastic/myeloproliferative neoplasm (unacceptable MDS subtypes); uncontrolled bacterial, viral or fungal infection (currently taking medication and with progression or no clinical improvement) at time of enrollment.
Patients with prior malignancies, except treated non-melanoma skin cancer or treated cervical carcinoma in situ. Cancer treated with curative surgery without chemotherapy/radiation therapy > 5 years previously will be allowed. Cancer treated with curative surgery < 5 years previously will not be allowed unless approved by the Protocol Officer or one of the Protocol Chairs.
Prior autologous or allogeneic HCT
Human Immunodeficiency Virus (HIV) infection
Patients of childbearing potential unwilling to use contraceptive techniques
Patients with psychosocial conditions that would prevent study compliance

Where it is running

City of Hope National Medical Center — Duarte, California, United States
Stanford Hospital and Clinics — Stanford, California, United States
University of Florida College of Medicine — Gainesville, Florida, United States
H. Lee Moffitt Cancer Center — Tampa, Florida, United States
Emory University — Atlanta, Georgia, United States
University of Chicago — Chicago, Illinois, United States
University of Kansas Hospital — Kansas City, Kansas, United States
University of Kentucky — Lexington, Kentucky, United States
University of Maryland Medical Systems - Greenebaum Cancer Center — Baltimore, Maryland, United States
Johns Hopkins — Baltimore, Maryland, United States
Dana Farber Cancer Institute/Brigham & Women's — Boston, Massachusetts, United States
Dana Farber Cancer Institute/Massachusetts General Hospital — Boston, Massachusetts, United States
Karmanos Cancer Institute/BMT — Detroit, Michigan, United States
Mayo Clinic - Rochester — Rochester, Minnesota, United States
Washington University/Barnes Jewish Hospital — St Louis, Missouri, United States
University of Nebraska Medical Center — Omaha, Nebraska, United States
Roswell Park Cancer Institute — Buffalo, New York, United States
Mount Sinai Hospital — New York, New York, United States
Memorial Sloan-Kettering Cancer Center — New York, New York, United States
University of North Carolina Hospital at Chapel Hill — Chapel Hill, North Carolina, United States
University of North Carolina — Chapel Hill, North Carolina, United States
Duke University Medical Center — Durham, North Carolina, United States
Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States
Jewish Hospital BMT Program — Cincinnati, Ohio, United States
University Hospitals of Cleveland/ Case Western — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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