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Wolff D, Radojcic V, Lafyatis R, et al. National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: IV. The 2020 Highly morbid forms report. Transplant Cell Ther. 2021;27(10):817-835doi: 10.1016/j.jtct.2021.06.001.
Wolff, D., Radojcic, V., Lafyatis, R., Cinar, R., Rosenstein, R. K., Cowen, E. W., Cheng, G. S., Sheshadri, A., Bergeron, A., Williams, K. M., Todd, J. L., Teshima, T., Cuvelier, G. D. E., Holler, E., McCurdy, S. R., Jenq, R. R., Hanash, A. M., Jacobsohn, D., Santomasso, B. D., Jain, S., Ogawa, Y., Steven, P., Luo, Z. K., Dietrich-Ntoukas, T., Saban, D., Bilic, E., Penack, O., Griffith, L. M., Cowden, M., Martin, P. J., Greinix, H. T., Sarantopoulos, S., Socie, G., Blazar, B. R., Pidala, J., Kitko, C. L., Couriel, D. R., Cutler, C., Schultz, K. R., Pavletic, S. Z., Lee, S. J., & Paczesny, S. (2021). National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: IV. The 2020 Highly morbid forms report. Transplantation and cellular therapy, 27(10), 817-835. https://doi.org/10.1016/j.jtct.2021.06.001
Wolff, Daniel, et al. "National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: IV. The 2020 Highly morbid forms report." Transplantation and cellular therapy vol. 27,10 (2021): 817-835. doi: https://doi.org/10.1016/j.jtct.2021.06.001
Wolff D, Radojcic V, Lafyatis R, Cinar R, Rosenstein RK, Cowen EW, Cheng GS, Sheshadri A, Bergeron A, Williams KM, Todd JL, Teshima T, Cuvelier GDE, Holler E, McCurdy SR, Jenq RR, Hanash AM, Jacobsohn D, Santomasso BD, Jain S, Ogawa Y, Steven P, Luo ZK, Dietrich-Ntoukas T, Saban D, Bilic E, Penack O, Griffith LM, Cowden M, Martin PJ, Greinix HT, Sarantopoulos S, Socie G, Blazar BR, Pidala J, Kitko CL, Couriel DR, Cutler C, Schultz KR, Pavletic SZ, Lee SJ, Paczesny S. National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: IV. The 2020 Highly morbid forms report. Transplant Cell Ther. 2021 Oct;27(10):817-835. doi: 10.1016/j.jtct.2021.06.001. Epub 2021 Jun 10. PMID: 34217703; PMCID: PMC8478861.
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Transplant Cell Ther. 2021 Oct;27(10):817-835. doi: 10.1016/j.jtct.2021.06.001. Epub 2021 Jun 10.

National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: IV. The 2020 Highly morbid forms report.

Transplantation and cellular therapy

Daniel Wolff, Vedran Radojcic, Robert Lafyatis, Resat Cinar, Rachel K Rosenstein, Edward W Cowen, Guang-Shing Cheng, Ajay Sheshadri, Anne Bergeron, Kirsten M Williams, Jamie L Todd, Takanori Teshima, Geoffrey D E Cuvelier, Ernst Holler, Shannon R McCurdy, Robert R Jenq, Alan M Hanash, David Jacobsohn, Bianca D Santomasso, Sandeep Jain, Yoko Ogawa, Philipp Steven, Zhonghui Katie Luo, Tina Dietrich-Ntoukas, Daniel Saban, Ervina Bilic, Olaf Penack, Linda M Griffith, Meredith Cowden, Paul J Martin, Hildegard T Greinix, Stefanie Sarantopoulos, Gerard Socie, Bruce R Blazar, Joseph Pidala, Carrie L Kitko, Daniel R Couriel, Corey Cutler, Kirk R Schultz, Steven Z Pavletic, Stephanie J Lee, Sophie Paczesny

Affiliations

  1. Department of Internal Medicine III, University Hospital Regensburg, Regensburg, Germany. Electronic address: [email protected].
  2. Division of Hematology and Hematologic Malignancies, Department of Internal Medicine, Huntsman Cancer Institute, University of Utah, Salt Lake City, Utah.
  3. Division of Rheumatology and Clinical Immunology, Department of Medicine, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.
  4. Section on Fibrotic Disorders, National Institute on Alcohol Abuse and Alcoholism, National Institutes of Health, Bethesda, Maryland.
  5. Center for Discovery and Innovation, Hackensack Meridian Health, Nutley, New Jersey.
  6. Dermatology Branch, National Institute of Arthritis and Musculoskeletal and Skin Diseases, Bethesda, Maryland.
  7. Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, Washington; Department of Medicine, University of Washington, Seattle, Washington.
  8. Department of Pulmonary Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas.
  9. Department of Pulmonary Medicine, AP-HP Saint Louis Hospital & University of Paris, Paris, France.
  10. Aflac Cancer and Blood Disorders Center, Children's Healthcare of Atlanta, Emory University, Atlanta, Georgia.
  11. Division of Pulmonary, Allergy and Critical Care Medicine, Duke University, Durham, North Carolina.
  12. Department of Hematology, Hokkaido University Faculty of Medicine, Sapporo, Japan.
  13. Pediatric Blood and Marrow Transplant, CancerCare Manitoba, University of Manitoba, Winnipeg, Manitoba, Canada.
  14. Department of Internal Medicine III, University Hospital Regensburg, Regensburg, Germany.
  15. Division of Hematology/Oncology, Department of Medicine, Perelman School of Medicine of the University of Pennsylvania, Philadelphia, Pennsylvania.
  16. Departments of Genomic Medicine and Stem Cell Transplantation and Cellular Therapy, University of Texas MD Anderson Cancer Center, Houston, Texas.
  17. Departments of Medicine and Human Oncology & Pathogenesis Program, Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, New York.
  18. Children's National Hospital, George Washington University, Washington, District of Columbia.
  19. Department of Neurology, Memorial Sloan Kettering Cancer Center, New York New York.
  20. Department of Ophthalmology, University of Illinois Eye & Ear Infirmary, Chicago, Illinois.
  21. Department of Ophthalmology, Keio University School of Medicine, Tokyo, Japan.
  22. Division for Dry-Eye and ocular GvHD, Department of Ophthalmology, Medical Faculty and University Hospital, University of Cologne, Cologne, Germany.
  23. Department of Ophthalmology, Massachusetts Eye and Ear, Harvard Medical School, Boston, Massachusetts.
  24. Charité-Universitätsmedizin Berlin, corporate member of Freie Universität Berlin und Humboldt-Universität Berlin, Department of Ophthalmology, Berlin, Germany.
  25. Department of Ophthalmology and Department of Immunology, Duke University School of Medicine, Durham, North Carolina.
  26. Department of Neurology, University of Zagreb School of Medicine, Zagreb, Croatia.
  27. Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Department of Hematology, Oncology and Tumorimmunology, Berlin, Germany.
  28. Division of Allergy Immunology and Transplantation, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.
  29. Cowden Foundation, Akron, Ohio.
  30. Clinical Division of Hematology, Medical University of Graz, Graz, Austria.
  31. Division of Hematological Malignancies and Cellular Therapy, Duke University Department of Medicine, Duke Cancer Institute, Durham, North Carolina.
  32. Hematology Transplantation, AP-HP Saint Louis Hospital & University of Paris, Paris, France.
  33. Department of Pediatrics, Division of Blood & Marrow Transplant & Cellular Therapy, University of Minnesota, Minneapolis, Minnesota.
  34. Department of Blood and Marrow Transplantation and Cellular Immunotherapy. H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida.
  35. Pediatric Stem Cell Transplant Program, Vanderbilt University Medical Center, Nashville, Tennessee.
  36. Division of Stem Cell Transplantation and Cellular Therapy, Dana-Farber Cancer Institute, Boston, Massachusetts.
  37. Pediatric Hematology/Oncology/BMT, BC Children's Hospital, Vancouver, British Columbia, Canada.
  38. Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland.
  39. Department of Microbiology and Immunology, Medical University of South Carolina, Charleston, South Carolina.

PMID: 34217703 PMCID: PMC8478861 DOI: 10.1016/j.jtct.2021.06.001

Abstract

Chronic graft-versus-host disease (GVHD) can be associated with significant morbidity, in part because of nonreversible fibrosis, which impacts physical functioning (eye, skin, lung manifestations) and mortality (lung, gastrointestinal manifestations). Progress in preventing severe morbidity and mortality associated with chronic GVHD is limited by a complex and incompletely understood disease biology and a lack of prognostic biomarkers. Likewise, treatment advances for highly morbid manifestations remain hindered by the absence of effective organ-specific approaches targeting "irreversible" fibrotic sequelae and difficulties in conducting clinical trials in a heterogeneous disease with small patient numbers. The purpose of this document is to identify current gaps, to outline a roadmap of research goals for highly morbid forms of chronic GVHD including advanced skin sclerosis, fasciitis, lung, ocular and gastrointestinal involvement, and to propose strategies for effective trial design. The working group made the following recommendations: (1) Phenotype chronic GVHD clinically and biologically in future cohorts, to describe the incidence, prognostic factors, mechanisms of organ damage, and clinical evolution of highly morbid conditions including long-term effects in children; (2) Conduct longitudinal multicenter studies with common definitions and research sample collections; (3) Develop new approaches for early identification and treatment of highly morbid forms of chronic GVHD, especially biologically targeted treatments, with a special focus on fibrotic changes; and (4) Establish primary endpoints for clinical trials addressing each highly morbid manifestation in relationship to the time point of intervention (early versus late). Alternative endpoints, such as lack of progression and improvement in physical functioning or quality of life, may be suitable for clinical trials in patients with highly morbid manifestations. Finally, new approaches for objective response assessment and exploration of novel trial designs for small populations are required.

Copyright © 2021 The American Society for Transplantation and Cellular Therapy. All rights reserved.

Keywords: Allogeneic hematopoietic cell transplantation; Chronic graft-versus-host disease; Consensus; Gastrointestinal tract; Lung; Ocular; Sclerosis; Skin

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