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Trial Outcomes & Findings for Bridging Pediatric and Adult Biomarkers in Graft-Versus-Host Disease (NCT NCT02194439)

NCT ID: NCT02194439

Last Updated: 2021-02-26

Results Overview

To measure stimulation-2 (ST2) pre-HCT by number of participants at 12 months post-HCT for non-relapse mortality according to ST2 values and age less than or equal to 10 and greater than 10 using landmark analyses.

Recruitment status

COMPLETED

Target enrollment

415 participants

Primary outcome timeframe

1 year

Results posted on

2021-02-26

Participant Flow

Participant milestones

Participant milestones
Measure
Hematopoietic Stem Cell Transplant
4 plasma biomarkers were assessed pre-HCT and at days +7, +14 and +21 post-HCT.
Overall Study
STARTED
415
Overall Study
COMPLETED
415
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Bridging Pediatric and Adult Biomarkers in Graft-Versus-Host Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Hematopoietic Stem Cell Transplant
n=415 Participants
4 plasma biomarkers were assessed pre-HCT and at days +7, +14 and +21 post-HCT.
Age, Customized
Age <10
170 Participants
n=93 Participants
Age, Customized
Age >10
245 Participants
n=93 Participants
Sex: Female, Male
Female
187 Participants
n=93 Participants
Sex: Female, Male
Male
228 Participants
n=93 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
55 Participants
n=93 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
351 Participants
n=93 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
9 Participants
n=93 Participants
Race (NIH/OMB)
American Indian or Alaska Native
5 Participants
n=93 Participants
Race (NIH/OMB)
Asian
15 Participants
n=93 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=93 Participants
Race (NIH/OMB)
Black or African American
51 Participants
n=93 Participants
Race (NIH/OMB)
White
293 Participants
n=93 Participants
Race (NIH/OMB)
More than one race
40 Participants
n=93 Participants
Race (NIH/OMB)
Unknown or Not Reported
11 Participants
n=93 Participants
Region of Enrollment
United States
415 participants
n=93 Participants

PRIMARY outcome

Timeframe: 1 year

Population: Participants who had all four biomarkers and four timepoints.

To measure stimulation-2 (ST2) pre-HCT by number of participants at 12 months post-HCT for non-relapse mortality according to ST2 values and age less than or equal to 10 and greater than 10 using landmark analyses.

Outcome measures

Outcome measures
Measure
Hematopoietic Stem Cell Transplant
n=415 Participants
4 plasma biomarkers were assessed pre-HCT and at days +7, +14 and +21 post-HCT.
Number of Participants With Non Relapse Mortality (NRM) by Age and ST2 at 12 Months Post-HCT
Age <10 high Pre-HCT ST2 >26
55 participants
Number of Participants With Non Relapse Mortality (NRM) by Age and ST2 at 12 Months Post-HCT
Age <10 low pre-HCT ST2 <26
115 participants
Number of Participants With Non Relapse Mortality (NRM) by Age and ST2 at 12 Months Post-HCT
Age >10 high Pre-HCT ST2 >26
125 participants
Number of Participants With Non Relapse Mortality (NRM) by Age and ST2 at 12 Months Post-HCT
Age >10 low Pre-HCT ST2 <26
120 participants

Adverse Events

Hematopoietic Stem Cell Transplant

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Sophie Paczesny

IndianaU

Phone: 317-278-5487

Results disclosure agreements

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