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

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  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.

  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.

    CAS  Article  Google Scholar 

  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.

    Article  Google Scholar 

  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.

    CAS  Article  Google Scholar 

  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.

    Article  Google Scholar 

  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.

    Article  Google Scholar 

  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.

    CAS  Article  Google Scholar 

  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.

    Article  Google Scholar 

  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.

    Article  Google Scholar 

  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.

    CAS  Article  Google Scholar 

  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.

    CAS  Article  Google Scholar 

  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.

    CAS  Article  Google Scholar 

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The authors wish to acknowledge the support provided by Xenikos and Grant Numbers U10HL069294 and U24HL138660 to the Blood and Marrow Transplant Clinical Trials Network from the National Heart, Lung and Blood Institute and the National Cancer Institute. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.

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GM, MH, MLM, HA, HC, PD, AH, WK, LP and JEL designed the research and wrote the paper. MM and EL analyzed the data and wrote the paper. IP, EvH, and YvO designed the research, performed research and wrote the paper. PV performed research and wrote the paper.

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Correspondence to Gabrielle Meyers.

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Competing interests

MH: Research Support/Funding: Takeda Pharmaceutical Company; Consultancy: Incyte Corporation; ADC Therapeutics; Pharmacyclics, Omeros, Kite. Speaker’s Bureau: Sanofi Genzyme, AstraZeneca, BeiGene. HA: Consultant and speaker bureau for Incyte, BMS. Research grant from Incyte. IP: Syndax Advisory Board. EvH, WK, and YvO: are employees of Xenikos and own equity in Xenikos. JEL: Research support from Biogen, Incyte, Kamada, and Mesoblast; consulting for Bluebird, Incyte, Jazz, Mesoblast, Omeros, Symbio, Talaris, and X4 Pharmaceuticals; GVHD biomarkers patent and royalties from Viracor.

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Meyers, G., Hamadani, M., Martens, M. et al. Lessons learned from early closure of a clinical trial for steroid-refractory acute GVHD. Bone Marrow Transplant 57, 302–303 (2022).

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