Allo vs Hypomethylating / Best Supportive Care in MDS (BMT CTN 1102)

Status: Active

Description

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.

Eligibility Criteria

Inclusion Criteria

  • 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) ≤
  • 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.
  • 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

Exclusion Criteria

  • 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

Locations & Contacts

Florida

Tampa
Moffitt Cancer Center
Status: Active
Name Not Available

Illinois

Chicago
University of Chicago Comprehensive Cancer Center
Status: Active
Name Not Available

Maryland

Baltimore
University of Maryland / Greenebaum Cancer Center
Status: Active
Contact: Sunita Philip
Phone: 410-328-8199
Email: sphilip1@umm.edu

Massachusetts

Boston
Brigham and Women's Hospital
Status: Active
Name Not Available
Dana-Farber Cancer Institute
Status: Active
Name Not Available
Massachusetts General Hospital Cancer Center
Status: Active
Name Not Available

New York

Buffalo
Roswell Park Cancer Institute
Status: Active
Name Not Available
New York
Memorial Sloan Kettering Cancer Center
Status: Active
Contact: Roni Tamari
Email: Tamarir@mskcc.org

North Carolina

Chapel Hill
UNC Lineberger Comprehensive Cancer Center
Status: Active
Name Not Available
Durham
Duke University Medical Center
Status: Active
Contact: Mitchell Eric Horwitz
Email: mitchell.horwitz@duke.edu

Ohio

Cleveland
Case Comprehensive Cancer Center
Status: Active
Contact: Hillard Michael Lazarus
Email: hillard.lazarus@case.edu

Oregon

Portland
OHSU Knight Cancer Institute
Status: Active
Contact: Richard T. Maziarz
Email: maziarzr@ohsu.edu

Pennsylvania

Philadelphia
University of Pennsylvania / Abramson Cancer Center
Status: Active
Name Not Available

Tennessee

Nashville
Vanderbilt University / Ingram Cancer Center
Status: Active
Name Not Available

Texas

Houston
M D Anderson Cancer Center
Status: Active
Contact: Betul Oran
Email: boran@mdanderson.org

Utah

Salt Lake City
Huntsman Cancer Institute / University of Utah
Status: Active
Contact: Tibor J. Kovacsovics
Email: tibor.kovacsovics@hci.utah.edu

Washington

Seattle
Fred Hutch / University of Washington Cancer Consortium
Status: Active
Contact: Bart Lee Scott
Email: bscott@fhcrc.org

Wisconsin

Milwaukee
Froedtert and the Medical College of Wisconsin
Status: Active
Contact: Wael Saber
Email: wsaber@mcw.edu

Trial Objectives and Outline

Background: MDS is a clonal disorder of hematopoietic precursors and stem cells, which may evolve to a terminal phase resembling acute leukemia. A subject of clinical urgency for researchers, clinicians, patients, and health care underwriters such as Medicare, is the role of allogeneic hematopoietic cell transplantation (alloHCT) in the treatment of older patients with higher risk myelodysplastic syndromes (MDS). The use of reduced intensity conditioning (RIC) regimens has extended HCT to the care of older patients with acute myelogenous leukemia (AML) and lymphoma and a number of retrospective and phase II trials for patients with MDS now show the curative potential of RIC alloHCT in selected patients. This protocol is designed to evaluate the relative benefits of RIC alloHCT compared to non-transplant therapies focusing on overall survival. This will be done by having patients biologically assigned to the alloHCT arm or the hypomethylating therapy/best supportive care arm and following them for survival at 3 years.

Trial Phase & Type

Trial Phase

Phase II

Trial Type

Treatment

Lead Organization

Lead Organization
Froedtert and the Medical College of Wisconsin

Trial IDs

Primary ID BMTCTN1102
Secondary IDs NCI-2015-00858, NCI-2014-00100, 2U10HL069294-11, 5U24CA076518, NCI-2015-00326
Clinicaltrials.gov ID NCT02016781