NCT02016781

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

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 (BMTCTN1102)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 384 (actual)
• Sponsor: Medical College of Wisconsin · Academic / Other
• Sex: All
• Age: 50 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• MDS

Interventions

Type	Name	Description
PROCEDURE	Allogeneic Hematopoietic Cell Transplant	Bone marrow or peripheral blood stem cell transplant.from a fully matched related (6/6) or unrelated (8/8) donor. The specific transplant treatment regimen will be at the discretion of the treating physician but is required to be reduced-intensity.
PROCEDURE	Hypomethylating Therapy / Best Supportive Care	The specific non-transplant treatment regimen will be at the discretion of the treating physician.

Timeline

• Start date: 2013-12-16
• Primary completion: 2021-10-05
• Completion: 2021-10-05
• First posted: 2013-12-20
• Last updated: 2023-03-03
• Results posted: 2022-07-29

Locations

37 sites across 1 country: United States