Trial Outcomes & Findings for The Myelodysplasia Transplantation-Associated Outcomes (MDS-TAO) Study (NCT NCT02390414)

NCT ID: NCT02390414

Last Updated: 2023-04-03

Results Overview

To prospectively compare the overall survival of patients in the HSCT group to that of patients in the non-HSCT group.

• Recruitment status: COMPLETED
• Target enrollment: 290 participants
• Primary outcome timeframe: 3 Years
• Results posted on: 2023-04-03

Participant Flow

Participant milestones

Measure	Gets HSCT Patients with higher-risk myelodysplastic syndrome (MDS) aged 60-75 who are fit for HSCT and actually undergo HSCT.	No HSCT Patients with higher-risk myelodysplastic syndrome (MDS) aged 60-75 who are fit for HSCT but do not undergo HSCT.
Overall Study STARTED	113	177
Overall Study COMPLETED	113	177
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Gets HSCT n=113 Participants Patients with higher-risk myelodysplastic syndrome (MDS) aged 60-75 who are fit for HSCT and actually undergo HSCT.	No HSCT n=177 Participants Patients with higher-risk myelodysplastic syndrome (MDS) aged 60-75 who are fit for HSCT but do not undergo HSCT.	Total n=290 Participants Total of all reporting groups
Age, Continuous	67 years n=5 Participants	70 years n=7 Participants	69 years n=5 Participants
Sex: Female, Male Female	40 Participants n=5 Participants	60 Participants n=7 Participants	100 Participants n=5 Participants
Sex: Female, Male Male	73 Participants n=5 Participants	117 Participants n=7 Participants	190 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	7 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) White	110 Participants n=5 Participants	168 Participants n=7 Participants	278 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
ECOG Performance Status 0	37 Participants n=5 Participants	53 Participants n=7 Participants	90 Participants n=5 Participants
ECOG Performance Status 1	69 Participants n=5 Participants	99 Participants n=7 Participants	168 Participants n=5 Participants
ECOG Performance Status 2	7 Participants n=5 Participants	24 Participants n=7 Participants	31 Participants n=5 Participants
ECOG Performance Status 3	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 Years

To prospectively compare the overall survival of patients in the HSCT group to that of patients in the non-HSCT group.

Outcome measures

Measure	Gets HSCT n=113 Participants Patients with higher-risk myelodysplastic syndrome (MDS) aged 60-75 who are fit for HSCT and actually undergo HSCT.	No HSCT n=177 Participants Patients with higher-risk myelodysplastic syndrome (MDS) aged 60-75 who are fit for HSCT but do not undergo HSCT.
Overall Survival	55 Participants	58 Participants

Adverse Events

Gets HSCT

Serious events: 0 serious events

Other events: 0 other events

Deaths: 58 deaths

No HSCT

Serious events: 0 serious events

Other events: 0 other events

Deaths: 119 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Gregory A. Abel

Dana-Farber Cancer Institute

Phone: 6176322304

Email: gaabel@partners.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place