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Updated: Jun 3, 2026
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High Throughput Sequential ELISA for Validation of Biomarkers of Acute Graft-Versus-Host Disease
Published on: October 31, 2012
Prognostic value of response after upfront therapy for acute GVHD
R M Saliba1, D R Couriel, S Giralt
1Department of Stem Cell Transplantation and Cellular Therapy, The University of Texas MD Anderson Cancer Center, Houston, TX 77030, USA. rsaliba@mdanderson.org
Bone Marrow Transplantation
|March 9, 2011
Summary
Assessing acute graft-versus-host disease (aGVHD) response by day 28 predicts patient survival. Early treatment response in acute GVHD trials significantly impacts non-relapse mortality, validating day-28 assessment.
Area of Science:
- Hematology
- Oncology
- Immunology
Background:
- Designing clinical trials for acute graft-versus-host disease (aGVHD) is challenging due to the lack of standardized endpoints.
- A national workshop addressed the need for improved endpoint assessment in the allogeneic stem cell transplant (allo-SCT) era.
Purpose of the Study:
- To evaluate the prognostic value of upfront therapy response in patients with aGVHD.
- To validate day-28 response as a primary endpoint for clinical trials in aGVHD treatment.
Main Methods:
- Retrospective analysis of 83 patients from two clinical trials for novel aGVHD therapies.
- Utilized Cox proportional hazards regression for multivariate analysis.
Main Results:
- Patients achieving complete response (CR) or partial response (PR) by day 28 had significantly lower 6-month non-relapse mortality (NRM) (16%) compared to non-responders (48%, P=0.005).
- The impact of response on NRM was independent of patient and aGVHD characteristics.
Conclusions:
- Day-28 response is a valid and significant predictor of NRM in aGVHD.
- This finding supports the use of day-28 response as a primary endpoint in clinical trials for upfront aGVHD therapy.
