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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 : Completed
First Posted : March 17, 2015
Results First Posted : April 3, 2023
Last Update Posted : April 3, 2023
Sponsor:
Information provided by (Responsible Party):
Gregory A. Abel, MD, Dana-Farber Cancer Institute

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Myelodysplastic Syndromes (MDS)
Enrollment 290
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Gets HSCT No HSCT
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 113 177
Completed 113 177
Not Completed 0 0
Arm/Group Title Gets HSCT No HSCT Total
Hide Arm/Group Description 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. Total of all reporting groups
Overall Number of Baseline Participants 113 177 290
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 113 participants 177 participants 290 participants
67
(60 to 75)
70
(60 to 75)
69
(60 to 75)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 113 participants 177 participants 290 participants
Female
40
  35.4%
60
  33.9%
100
  34.5%
Male
73
  64.6%
117
  66.1%
190
  65.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 113 participants 177 participants 290 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   0.9%
1
   0.6%
2
   0.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
   1.8%
7
   4.0%
9
   3.1%
White
110
  97.3%
168
  94.9%
278
  95.9%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
1
   0.6%
1
   0.3%
ECOG Performance Status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 113 participants 177 participants 290 participants
0
37
  32.7%
53
  29.9%
90
  31.0%
1
69
  61.1%
99
  55.9%
168
  57.9%
2
7
   6.2%
24
  13.6%
31
  10.7%
3
0
   0.0%
1
   0.6%
1
   0.3%
[1]
Measure Description:

Eastern Cooperative Oncology Group (ECOG) Performance Status Scale.

0= Fully active, able to carry on all pre-disease performance without restriction. 1= Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2= Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours. 3= Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours

1.Primary Outcome
Title Overall Survival
Hide Description To prospectively compare the overall survival of patients in the HSCT group to that of patients in the non-HSCT group.
Time Frame 3 Years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Gets HSCT No HSCT
Hide Arm/Group Description:
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 Number of Participants Analyzed 113 177
Measure Type: Count of Participants
Unit of Measure: Participants
55
  48.7%
58
  32.8%
Time Frame All-Cause Mortality was monitored/assessed for 3 years
Adverse Event Reporting Description Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed
 
Arm/Group Title Gets HSCT No HSCT
Hide Arm/Group Description 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.
All-Cause Mortality
Gets HSCT No HSCT
Affected / at Risk (%) Affected / at Risk (%)
Total   58/113 (51.33%)   119/177 (67.23%) 
Hide Serious Adverse Events
Gets HSCT No HSCT
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Gets HSCT No HSCT
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Gregory A. Abel
Organization: Dana-Farber Cancer Institute
Phone: 6176322304
EMail: gaabel@partners.org
Layout table for additonal information
Responsible Party: Gregory A. Abel, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT02390414    
Other Study ID Numbers: 11-056
First Submitted: March 11, 2015
First Posted: March 17, 2015
Results First Submitted: March 3, 2022
Results First Posted: April 3, 2023
Last Update Posted: April 3, 2023