CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 384 enrolled
Drug / intervention
Allogeneic Hematopoietic Cell Transplant +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02016781
NCT02016781Phase 2Completed
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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 (BMTCTN1102)

Medical College of Wisconsin·interventional·Posted Dec 20, 2013·Updated Mar 3, 2023

In Brief

A Phase 2 clinical trial evaluating Allogeneic Hematopoietic Cell Transplant and Hypomethylating Therapy / Best Supportive Care for MDS. Completed, enrolled 384 participants across 37 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMDS
CountriesUnited States
CollaboratorsNational Heart, Lung, and Blood Institute (NHLBI), National Cancer Institute (NCI), Blood and Marrow Transplant Clinical Trials Network, National Marrow Donor Program

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedDec 20, 2013
Enrollment StartDec 16, 2013
Primary CompletionOct 5, 2021
TodayJul 2, 2026
Enrollment to primary: 7.8 yearsPosted 12.5 years ago

Interventions

Allogeneic Hematopoietic Cell Transplantprocedure

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.

Hypomethylating Therapy / Best Supportive Careprocedure

The specific non-transplant treatment regimen will be at the discretion of the treating physician.