Six Month Freedom from Treatment Failure is an Important Endpoint for Acute Graft-Versus-Host Disease Clinical Trials

@article{Sengsayadeth2013SixMF,
  title={Six Month Freedom from Treatment Failure is an Important Endpoint for Acute Graft-Versus-Host Disease Clinical Trials},
  author={Salyka M. Sengsayadeth and Bipin N. Savani and Madan H. Jagasia and Stacey A. Goodman and John P. Greer and Heidi Chen and Wichai Chinratanalab and Adetola A. Kassim and Brian G Engelhardt},
  journal={Bone marrow transplantation},
  year={2013},
  volume={49},
  pages={236 - 240},
  url={https://api.semanticscholar.org/CorpusID:8887397}
}
The 6-m FFTF end point measures fixed outcomes, predicts long-term therapeutic success and could be less prone to measurement error than aGVHD clinical response at day 28.
View on Nature
ncbi.nlm.nih.gov
3 Citations
Results Citations
1

3 Citations

Extracorporeal photopheresis as second-line treatment for acute graft-versus-host disease: impact on six-month freedom from treatment failure

The durable effect of photopheresis as second-line therapy for corticosteroid-refractory or -dependent acute graft-versus-host disease is demonstrated using 6-month freedom from treatment failure as the primary endpoint.

Extracorporeal photopheresis is a valuable treatment option in steroid-refractory or steroid-dependent acute graft versus host disease—experience with three different approaches

Treatment outcomes for three approaches to the use of ECP for aGvHD are presented and response at predetermined time points are assessed to facilitate comparison with existing and future studies on second-or-further-line therapies for a GvHD.

Acute Graft-Versus-Host Disease (GvHD)

    S. Slater
    Medicine
    Blood and Marrow Transplant Handbook
  • 2021
Despite advances in human leukocyte antigen (HLA) typing, acute graft-versus-host disease (aGVHD) remains a leading cause of morbidity and mortality among allogeneic hematopoietic stem cell…

12 References

The best endpoint for acute GVHD treatment trials.

Day 28 responses were similar to day 56 responses and better than day 14 responses in predicting transplantation-related mortality (TRM) and suggest that day 28 is the best early endpoint for acute GVHD therapeutic trials in predicting 2-year TRM.

Graft-versus-host disease treatment: predictors of survival.

Prognostic value of response after upfront therapy for acute GVHD

This study evaluated the prognostic value of response to upfront therapy in a cohort of 83 patients who had been enrolled on two clinical trials testing novel therapies for aGVHD at an institution and confirmed the validity of using day-28 response as a primary end point in clinical trials for upfront therapy for aGFD.

Novel treatment concepts for graft-versus-host disease.

There is an urgent clinical need to develop more potent immunosuppressive treatment strategies for patients suffering from acute or chronic steroid-refractory GVHD while maintaining the graft versus tumor effect to avoid a potential rise in relapse-related mortality.

First- and second-line systemic treatment of acute graft-versus-host disease: recommendations of the American Society of Blood and Marrow Transplantation.

Endpoints for clinical trials testing treatment of acute graft-versus-host disease: a joint statement.

1994 Consensus Conference on Acute GVHD Grading.

Reports of GVHD prevention trials should include an accurate description of the grading system used and should report actuarial rates of grades II-IV and III-IV GV HD corrected for graft failure and potential interventions for early relapse.

Study design and endpoints in graft-versus-host disease.

Tissue-specific regulatory T cells: biomarker for acute graft-vs-host disease and survival.

National Institutes of Health consensus development project on criteria for clinical trials in chronic graft-versus-host disease: I. Diagnosis and staging working group report.

This consensus document standardizes the criteria for diagnosis of chronic graft-versus-host disease (GVHD) and proposes a new clinical scoring system (0-3) that describes the extent and severity of chronic GVHD for each organ or site at any given time, taking functional impact into account.