Basiliximab Combined With Ruxolitinib as Second-line Treatment of Grade 3-4 Steroid-resistant aGVHD

Phase 4 Unknown 50 enrolled The First Affiliated Hospital of Soochow University Soochow Hopes Hematonosis Hospital · collab The Second People's Hospital of Huai'an · collab

NaSingle-groupOpen-labelTreatment

Summary

Acute graft-versus-host disease (aGVHD) is the most common life-threatening complication of allogeneic hematopoietic stem cell transplantation. The recognized first-line treatment for grade 3-4 aGVHD is systemic glucocorticoid. However, there is no recognized second-line treatment for grade 3-4 steroid-resistant aGVHD (SR-aGVHD). The investigators try to observe the efficacy and safety of early application of anti-CD25 monoclonal antibody(basiliximab) combined with ruxotilinib in the treatment of severe SR-aGVHD.

Timeline

Start: 2020-12-15
Primary completion: 2022-07-31
Completion: 2022-12-15

Publications

Zhou F, Pan T, Li X, Du F, Ma X, Zhang Y, Wu D, Han Y, Xue S, Miao M, Tao T, He X, Chen S. 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. 2023 Aug;58(8):959-961. doi: 10.1038/s41409-023-02005-4. Epub 2023 May 30. No abstract available.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Basiliximab	Monoclonal antibody	20 mg	—
Subject	Ruxolitinib	Small molecule	5 mg	—
Subject	Ruxolitinib	Small molecule	10 mg	—

Indications

No indication recorded.