The Myelodysplasia Transplantation-Associated Outcomes (MDS-TAO) Study
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02390414|
Recruitment Status : Active, not recruiting
First Posted : March 17, 2015
Last Update Posted : August 3, 2020
|Condition or disease|
|Myelodysplastic Syndromes (MDS)|
MDS is a hematologic malignancy characterized by cytopenias, bone marrow failure, and a risk of transformation to acute myeloid leukemia (AML). HSCT is the only curative therapy for MDS. Despite its increasing use among older patients (age greater than 60), more data are needed to assess outcomes of HSCT in older adults compared to other therapies.
In this observational study, patients with MDS presenting at the study institutions are screened for disease characteristics that indicate that they are potentially appropriate for HSCT (both high-risk disease and fit for the procedure). Patients who meet inclusion and exclusion criteria and agree to participate in the study are entered into a clinical database and followed for overall survival. Patients also complete quality of life (QoL) assessments at enrollment and two years afterward, with the goal of investigating potential relationships between QoL and MDS treatment (HSCT vs. non-HSCT strategies).
|Study Type :||Observational|
|Actual Enrollment :||290 participants|
|Official Title:||The Myelodysplasia Transplantation-Associated Outcomes (MDS-TAO) Study|
|Actual Study Start Date :||May 2011|
|Estimated Primary Completion Date :||May 2023|
|Estimated Study Completion Date :||May 2023|
Patients with higher-risk myelodysplastic syndrome (MDS) aged 60-75 who are fit for HSCT and actually undergo HSCT.
Patients with higher-risk myelodysplastic syndrome (MDS) aged 60-75 who are fit for HSCT but do not undergo HSCT.
- Overall Survival [ Time Frame: 5 Years ]To prospectively compare the overall survival of patients in the HSCT group to that of patients in the non-HSCT group.
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): NCT02390414
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Dana Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Gregory A Abel, MD, MPH||Dana-Farber Cancer Institute|