Allo vs Hypomethylating/Best Supportive Care in MDS (BMT CTN 1102)
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|ClinicalTrials.gov Identifier: NCT02016781|
Recruitment Status : Recruiting
First Posted : December 20, 2013
Last Update Posted : March 22, 2018
|Condition or disease||Intervention/treatment||Phase|
|MDS||Procedure: Allogeneic Hematopoietic Cell Transplant Procedure: Hypomethylating Therapy / Best Supportive Care Drug: Reduced Intensity Conditioning||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||400 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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)|
|Actual Study Start Date :||December 2013|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||June 2021|
Active Comparator: Transplant
Reduced intensity conditioning allogeneic hematopoietic cell transplantation (RIC-alloHCT)
Procedure: Allogeneic Hematopoietic Cell Transplant
Bone marrow or peripheral blood stem cell transplant.
Other Name: RIC alloHCTDrug: Reduced Intensity Conditioning
The specific transplant treatment regimen will be at the discretion of the treating physician.
Other Name: RIC
Active Comparator: Non-Transplant
Hypomethylating Therapy / Best Supportive Care
Procedure: Hypomethylating Therapy / Best Supportive Care
The specific non-transplant treatment regimen will be at the discretion of the treating physician.
Other Name: Non-transplant
- Overall survival probabilities [ Time Frame: 3 years ]The primary objective for this study is to compare three-year overall survival probabilities between two treatment arms. Overall survival is calculated for all patients from date of patient consent until death from any cause. Observation is censored at the date of last follow-up for patients last known to be alive
- Leukemia-free survival (LFS) [ Time Frame: 3 years ]LFS is defined as the time from the date of patient consent to the date of progression to AML or death from any cause, whichever comes first. Observation is censored at the date of last follow-up for patients known to be alive without leukemia.
- QOL measures [ Time Frame: 3 years ]Health-Related QoL will be measured using patient reported surveys.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02016781
Show 36 Study Locations
|Study Director:||Mary Horowitz, MD, MS||Center for International Blood and Marrow Transplant Research (CIBMTR), Medical College of Wisconsin|