Blood and Marrow Clinical Trials Network (BMT CTN) Prospective Multi-Center Cohort for the Evaluation of Biomarkers Predicting Risk of Complications and Mortality Following Allogeneic HCT (1202)
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June 2013 – September 2016
Dataset(s) Last Updated
October 10, 2022
Clinical Trial URLs
Primary Publication URLs
Commercial Use Data Restrictions No
Data Restrictions Based On Area Of Research No
To establish accurate and reproducible methods to diagnose, grade, and report acute graft-versus-host disease in patients post-hematopoietic cell transplantation.
Graft-versus-host disease (GVHD) remains the most significant treatment–related complication of allogeneic hematopoietic cell transplantation (HCT). Recent results from single center studies suggest that biomarkers can be identified that stratify patients into discrete risk groups. However, accurate, reproducible methods to diagnose and grade GVHD are needed for the evaluation of new treatments and biomarkers for GVHD. The challenge in developing such methods stems from the heterogeneity in clinical presentation of GVHD, the variability in data reporting between centers, and the low specificity of signs, symptoms, and pathologic findings.
The Blood and Marrow Transplant Clinical Trials Network (BMT CTN) 1202 trial was established for the longitudinal collection of comprehensive, standardized, high quality clinical data for the study of biomarkers for GVHD and other outcomes.
Participants with a malignant or non-malignant hematologic disorder receiving allogeneic HCT were eligible. Eligible children had to weigh at least 20 kilograms to participate.
The study enrolled 1744 patients, of whom 1709 received transplantation.
The BMT CTN 1202 study was a multicenter prospective observational study. Participants received a cord blood graft, or bone marrow or peripheral blood graft from a related donor or from an unrelated donor. For the first 100 days post-HCT, highly detailed data, such as symptoms in GVHD organs, was collected. After Day 100, summary data was collected through 2 years post-HCT. Conditioning regimens, GVHD prophylaxis, and other supportive care followed institutional guidelines.
An endpoint review committee (ERC) performed near-real time review of all case report forms that listed new onset of symptoms suggestive of GVHD. The ERC considered cases with either probable or confirmed confidence levels to be diagnostic of GVHD. Probable GVHD required GVHD to be the most likely etiology for clinical symptoms and treatment for GVHD to be administered. Confirmed GVHD required appropriate clinical symptoms along with unequivocal pathologic evidence of GVHD.
This study demonstrates that the incidence of GVHD may be overestimated at symptom onset, establishes a contemporary benchmark for acute GVHD, and suggests a structured framework for reporting and adjudication of GVHD that could be used in prospective trials.
Reshef R, Saber W, Bolaños-Meade J, et al. Acute GVHD Diagnosis and Adjudication in a Multicenter Trial: A Report From the BMT CTN 1202 Biorepository Study. J Clin Oncol. 2021;39(17):1878-1887. doi:10.1200/JCO.20.00619
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