drugset / Trial / NCT02614612
Study of Itacitinib in Combination With Corticosteroids for the Treatment of Acute GVHD
RandomizedParallel-groupOpen-labelTreatment
Summary
To determine if Itacitinib in combination with corticosteroids is safe and tolerable in patients with Grade IIB-IVD acute graft-versus-host disease (GVHD).
Timeline
- Start
- 2015-12
- Primary completion
- 2016-06
- Completion
- 2018-08
Publications
- Pratta M, Paczesny S, Socie G, Barkey N, Liu H, Owens S, Arbushites MC, Schroeder MA, Howell MD. A biomarker signature to predict complete response to itacitinib and corticosteroids in acute graft-versus-host disease. Br J Haematol. 2022 Aug;198(4):729-739. doi: 10.1111/bjh.18300. Epub 2022 Jun 11.
- Schroeder MA, Khoury HJ, Jagasia M, Ali H, Schiller GJ, Staser K, Choi J, Gehrs L, Arbushites MC, Yan Y, Langmuir P, Srinivas N, Pratta M, Perales MA, Chen YB, Meyers G, DiPersio JF. A phase 1 trial of itacitinib, a selective JAK1 inhibitor, in patients with acute graft-versus-host disease. Blood Adv. 2020 Apr 28;4(8):1656-1669. doi: 10.1182/bloodadvances.2019001043.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Itacitinib | Small molecule | 200 mg | — |
| Subject | Itacitinib | Small molecule | 300 mg | — |
| Background | Methylprednisolone | Other / unclassified | 2 mg/kg | Intravenous |
| Background | Prednisone | Other / unclassified | 2.5 mg/kg | Oral |