Trial Outcomes & Findings for Prospective Cohort for the Evaluation of Biomarkers Following HCT (BMT CTN 1202) (NCT NCT01879072)

NCT ID: NCT01879072

Last Updated: 2022-12-09

Results Overview

The primary outcome will be measured by the number of participants who supply biologic samples. The prospectively collected samples will be a shared bio specimen resource for conducting future correlative studies.

• Recruitment status: COMPLETED
• Target enrollment: 1860 participants
• Primary outcome timeframe: Two years from hematopoietic stem cell transplant
• Results posted on: 2022-12-09

Participant Flow

Participant milestones

Measure	Allogeneic Hematopoietic Stem Cell Transplant Participants received allogeneic hematopoietic stem cell transplantation
Overall Study STARTED	1860
Overall Study COMPLETED	1709
Overall Study NOT COMPLETED	151

Reasons for withdrawal

Measure	Allogeneic Hematopoietic Stem Cell Transplant Participants received allogeneic hematopoietic stem cell transplantation
Overall Study Withdrawal by Subject	121
Overall Study Not Transplanted	30

Baseline Characteristics

Prospective Cohort for the Evaluation of Biomarkers Following HCT (BMT CTN 1202)

Baseline characteristics by cohort

Measure	Allogeneic Hematopoietic Stem Cell Transplant n=1709 Participants Participants received allogeneic hematopoietic stem cell transplantation
Age, Continuous	52.7 years n=5 Participants
Sex: Female, Male Female	701 Participants n=5 Participants
Sex: Female, Male Male	1008 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	128 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1552 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	29 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	9 Participants n=5 Participants
Race (NIH/OMB) Asian	59 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	5 Participants n=5 Participants
Race (NIH/OMB) Black or African American	203 Participants n=5 Participants
Race (NIH/OMB) White	1370 Participants n=5 Participants
Race (NIH/OMB) More than one race	13 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	50 Participants n=5 Participants

PRIMARY outcome

Timeframe: Two years from hematopoietic stem cell transplant

The primary outcome will be measured by the number of participants who supply biologic samples. The prospectively collected samples will be a shared bio specimen resource for conducting future correlative studies.

Outcome measures

Measure	Allogeneic Hematopoietic Stem Cell Transplant n=1709 Participants Participants received allogeneic hematopoietic stem cell transplantation
Number of Participants Providing Biologic Samples	1709 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

Adam Mendizabal, PhD

The Emmes Corporation

Phone: 301-251-1161

Email: amendizabal@emmes.com

Results disclosure agreements

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