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Exploration of efficacy and safety of combined therapy of basiliximab with ruxolitinib for grade 3–4 steroid-refractory acute graft-versus-host disease: a registered clinical trial (NCT05021276)

Bone Marrow Transplantation volume 58, pages 959–961 (2023)Cite this article

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Acute graft versus host disease (aGVHD) is the main cause of morbidity and mortality after allogeneic hematopoietic stem cell transplantation(HSCT). The first-line therapy for grade 2–4 aGVHD is prednisolone or equivalent 1–2 mg/kg. Reported response rates to first-line therapy are only about 55–65% [1]. Basiliximab, a chimeric monoclonal antibody of IL-2R and one of the most commonly used second-line therapeutic agents for steroid-resistant aGVHD(SR-aGVHD) in China, is reported to have an ORR of 43.6% at day 28 for patients with grade 3–4 SR-aGVHD [2]. Ruxolitinib, an oral selective JAK1/JAK2 inhibitor, whose efficacy and safety has been proved by REACH trials, has been approved as the only therapeutic agent for SR-GVHD patients ≥12 years old by FDA [3,4,5]. We developed a novel approach to treat grade 3–4 SR-aGVHD by the combination of basiliximab and ruxolitinib, and designed a multi-center prospective study.

In total, 50 patients who were older than 12 years old with grade 3–4 SR-aGVHD were recruited at transplant centers of The First Affiliated Hospital of Soochow University, Soochow Hopes Hematonosis Hospital, Huai’an Second People’s Hospital from August 2018 through April 2022. SR-aGVHD was defined as newly diagnosed with aGVHD (according to Mount Sinai Acute GVHD International Consortium criteria, MAGIC criteria) and showed progression after 3 days of steroid therapy, or no improvement after at least 5 days of steroid treatment, or inability to taper steroids. All the patients gave their written informed consent. The protocol was approved by the ethics review committee of each center and registered at ClinicalTrials.gov(NCT05021276).

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References

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Authors and Affiliations

  1. National Clinical Research Center for Hematologic Diseases, Jiangsu Institute of Hematology, The First Affiliated Hospital of Soochow University, Suzhou, China

    Fei Zhou, Tingting Pan, Xiao Ma, Depei Wu, Yue Han, Shengli Xue, Miao Miao, Xuefeng He & Suning Chen

  2. Soochow Hopes Hematonosis Hospital, Suzhou, China

    Xiaoli Li & Feng Du

  3. Department of Hematology, Huai’an Hospital Affiliated to Xuzhou Medical College and Huai’an Second People’s Hospital, Huai’an, China

    Yanming Zhang

  4. Suzhou Fifth People’s Hospital, Suzhou, China

    Tao Tao

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  1. Fei Zhou
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  2. Tingting Pan
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  12. Xuefeng He
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  13. Suning Chen
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Contributions

FZ, XH and SC designed the clinical trial. FZ, TP analyzed the data and wrote the manuscript draft. XL, FD contributed to searching the database. FZ, TP, XM and YZ contributed to the data analysis. FZ, DW, YH, SX, MM, TT, XH and SC supervised and revised the manuscript.

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Correspondence to Xuefeng He or Suning Chen.

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Zhou, F., Pan, T., Li, X. et al. Exploration of efficacy and safety of combined therapy of basiliximab with ruxolitinib for grade 3–4 steroid-refractory acute graft-versus-host disease: a registered clinical trial (NCT05021276). Bone Marrow Transplant 58, 959–961 (2023). https://doi.org/10.1038/s41409-023-02005-4

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