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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)

Status
Active
Cancer Type
Myelodysplastic Syndromes (MDS)
Trial Phase
Eligibility
50 to 75, Male and Female
Study Type
Biomarker/Laboratory analysis
Natural history/Epidemiology
NCD ID
NCT02016781
Protocol IDs
BMTCTN1102 (primary)
NCI-2015-00858
2U10HL069294-11
NCI-2014-00100
NCI-2015-00326
Study Sponsor
Wisconsin Clinical Cancer Center

Summary

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.

Objectives

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.

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