Safety and Efficacy of Efavaleukin Alfa in Subjects With Steroid Refractory Chronic Graft Versus Host Disease
Stopped early · Phase 1/Phase 2
Conditions studied: Chronic Graft Versus Host Disease cGVHD
In brief
Phase 1b: To evaluate the safety and tolerability of multiple ascending doses of efavaleukin alfa in subjects with steroid refractory chronic graft versus host disease (cGVHD). Phase 2: To evaluate the efficacy of efavaleukin alfa in subjects with steroid refractory cGVHD as measured by overall response rate (ORR) at 16 weeks according to the 2014 cGVHD NIH Consensus Criteria. Due to early termination, the Phase 2 portion of this study was not conducted.
Key facts
- Study ID
- NCT03422627
- Run by
- Amgen
- People needed
- 32
- Starts
- 2018-04-27
- Expected to finish
- 2022-10-13
- Last updated by the study team
- 2023-11-22
Who can join
Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.
Where it is running
- City of Hope National Medical Center — Duarte, California, United States
- Moffitt Cancer Center — Tampa, Florida, United States
- Emory University — Atlanta, Georgia, United States
- Dana Farber Cancer Institute — Boston, Massachusetts, United States
- Mayo Clinic Rochester — Rochester, Minnesota, United States
- The Ohio State University Wexner Medical Center Arthur G James Cancer Hospital and Solove Research — Columbus, Ohio, United States
- Texas Oncology Baylor — Dallas, Texas, United States
- Fred Hutchinson Cancer Research Center — Seattle, Washington, United States
- Universitair Ziekenhuis Leuven - Campus Gasthuisberg — Leuven, Belgium
- CHU Grenoble Alpes — Grenoble, France
- Hôpital Saint Louis — Paris, France
- Okayama University Hospital — Okayama, Okayama-ken, Japan
- Osaka City University Hospital — Osaka, Osaka, Japan
- National Cancer Center Hospital — Chuo-ku, Tokyo, Japan
Full record on ClinicalTrials.gov
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