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Bone Marrow Transplant. 2021 Nov 23; doi: 10.1038/s41409-021-01529-x. Epub 2021 Nov 23.

Lessons learned from early closure of a clinical trial for steroid-refractory acute GVHD.

Bone marrow transplantation

Gabrielle Meyers, Mehdi Hamadani, Michael Martens, Haris Ali, Hannah Choe, Peter Dawson, Andrew C Harris, Eric van Hooren, Willem Klaassen, Eric Leifer, Margaret L MacMillan, Ypke van Oosterhout, Lia Perez, Iskra Pusic, Phuong Vo, John E Levine

Affiliations

  1. Department of Medicine, Oregon Health and Science University, Knight Cancer Institute, Portland, OR, USA. [email protected].
  2. BMT & Cellular Therapy Program, Department of Medicine, Medical College of Wisconsin, Milwaukee, WI, USA.
  3. Medical College of Wisconsin, Milwaukee, WI, USA.
  4. Division of Leukemia, Department of Hematology and Hematopoietic Cell Transplantation, City of Hope National Medical, Duarte, CA, USA.
  5. Division of Hematology, The Ohio State University Comprehensive Cancer Center-James, Columbus, OH, USA.
  6. The Emmes Company, Rockville, MD, USA.
  7. MSK Kids Stem Cell Transplantation and Cellular Therapies, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
  8. Xenikos BV, Nijmegen, The Netherlands.
  9. National Heart, Lung, and Blood Institute, Bethesda, MD, USA.
  10. Blood and Marrow Transplantation & Cellular Therapy Program, Department of Pediatrics, University of Minnesota, Minneapolis, MN, USA.
  11. H. Lee Moffitt Cancer Center, Tampa, FL, USA.
  12. Division of Oncology, BMT and Leukemia Section, Washington University School of Medicine, St. Louis, MO, USA.
  13. Clinical Research Division, Fred Hutchinson Cancer Research Center, Department of Medicine, University of Washington School of Medicine, Seattle, WA, USA.
  14. Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, NY, USA.

PMID: 34815518 DOI: 10.1038/s41409-021-01529-x

[No abstract available.]

References

  1. Westin JR, Saliba RM, De Lima M, Alousi A, Hosing C, Qazilbash MF, et al. Steroid-refractory acute GVHD: predictors and outcomes. Adv Hematol. 2011. https://doi.org/10.1155/2011/601953 . - PubMed
  2. Xhaard A, Rocha V, Bueno B, de Latour RP, Lenglet J, Petropoulou A, et al. Steroid-refractory acute GVHD: lack of long-term improved survival using new generation anticytokine treatment. Biol Blood Marrow Transpl. 2012;18:406–13. - PubMed
  3. Zeiser R, von Bubnoff N, Butler J, Mohty M, Niederwieser D, Or R, et al. Ruxolitinib for glucocorticoid-refractory acute graft-versus-host disease.REACH2 Trial Group. N. Engl J Med 2020;;382:1800–10. - PubMed
  4. Jagasia M, Perales MA, Schroeder MA, Haris A, Shah NN, Chen Y-B, et al. Ruxolitinib for the treatment of steroid-refractory acute GVHD (REACH1): a multicenter, open-label phase 2 trial. Blood. 2020;135:1739–1749. - PubMed
  5. van Oosterhout YV, van Emst L, Schattenberg AV, Tax WJ, Ruiter DJ, Spits H, et al. A combination of anti-CD3 and anti-CD7 ricin A-immunotoxins for the in vivo treatment of acute graft versus host disease. Blood. 2000;95:3693–701. - PubMed
  6. van Oosterhout YV, van Emst JL, Bakker HH, Preijers FW, Schattenberg AV, Ruiter DJ, et al. Production of anti-CD3 and anti-CD7 ricin A-immunotoxins for a clinical pilot study. Int J Pharm. 2001;221:175–86. - PubMed
  7. Groth C, van Groningen LFJ, Matos TR, Bremmers ME, Preijers FWMB, Dolstra H, et al. Phase I/II Trial of a Combination of Anti-CD3/CD7 Immunotoxins for Steroid-Refractory Acute Graft-versus-Host Disease. Biol Blood Marrow Transpl. 2019;25:712–9. - PubMed
  8. van Groningen LFJ, Groth C, Bremmers MEJ, Hooren EG, van Oosterhout YVJM, Blijlevens NMA, et al. Results from an Expanded Access Program of Anti-CD3/CD7 Immunotoxin Combination (T-Guard) for the Treatment of Steroid-Refractory Acute GVHD. Blood. 2019;134:4553. - PubMed
  9. Harris AC, Young R, Devine S, Hogan WJ, Ayuk F, Bunworasate U, et al. International, Multicenter Standardization of Acute Graft-versus-Host Disease Clinical Data Collection: A Report from the Mount Sinai Acute GVHD International Consortium. Biol Blood Marrow Transpl. 2016;22:4–10. - PubMed
  10. Fuji S, Takano K, Mori T, Eto T, Taniguchi S, Ohashi K, et al. Impact of pretransplant body mass index on the clinical outcome after allogeneic hematopoietic SCT. Bone Marrow Transpl. 2014;49:1505–12. - PubMed
  11. Gleimer M, Li Y, Chang L, Paczesny S, Hanauer DA, Frame DG, et al. Baseline body mass index among children and adults undergoing allogeneic hematopoietic cell transplantation: clinical characteristics and outcomes. Bone Marrow Transpl. 2015;50:402–10. - PubMed
  12. Rashidi A, DeFor TE, Holtan SG, Blazar BR, Weisdorf DJ, MacMillan ML. Outcomes and predictors of response in steroid-refractory acute graft-versus-host disease. Biol Blood Marrow Transpl. 2019;25:2297–302. - PubMed

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