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

NCT02016781 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 384

Last updated 2023-03-03

Study results available
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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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • National Cancer Institute (NCI)

    collaborator NIH

  • Blood and Marrow Transplant Clinical Trials Network

    collaborator NETWORK

  • National Marrow Donor Program

    collaborator OTHER

  • Medical College of Wisconsin

    lead OTHER

Principal Investigators

  • Mary Horowitz, MD, MS · Center for International Blood and Marrow Transplant Research (CIBMTR), Medical College of Wisconsin

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-16
Primary Completion
2021-10-05
Completion
2021-10-05

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02016781 on ClinicalTrials.gov