NCT02390414

The Myelodysplasia Transplantation-Associated Outcomes (MDS-TAO) Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 290 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 60 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this observational study is to compare overall survival in older adults with myelodysplastic syndromes (MDS) who receive reduced intensity conditioning hematopoietic stem cell transplant (RIC HSCT) versus those who do not receive HSCT.

Detailed description

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).

Conditions

• Myelodysplastic Syndromes (MDS)

Timeline

• Start date: 2011-05-01
• Primary completion: 2020-09-01
• Completion: 2020-09-01
• First posted: 2015-03-17
• Last updated: 2023-04-03
• Results posted: 2023-04-03

Locations

3 sites across 1 country: United States