Actively Recruiting
Phase 2 Study of AK117 and Azacitidine Compared to Placebo in Treating Newly Diagnosed Higher-risk Myelodysplastic Syndromes
Led by Akeso · Updated on 2025-02-11
90
Participants Needed
15
Research Sites
21 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of AK117 combined with azacitidine compared to placebo with azacitidine in adults with newly diagnosed higher-risk myelodysplastic syndromes HR-MDS. This Phase 2 study is randomized, double-blind, placebo-controlled, and conducted at multiple centers to better understand treatment options for this condition. Participants receive either one of two doses of AK117 intravenously along with azacitidine given as a subcutaneous injection on days 1 to 7 of each 28-day cycle, or a placebo intravenously combined with the same azacitidine regimen. The study compares these groups to assess different dosing effects and safety profiles over time. During the study, participants will undergo regular assessments including bone marrow sample collections and blood tests to monitor response and safety. Researchers will measure outcomes such as complete remission rate, overall response, time to response, duration of response, event-free survival, and overall survival for up to about two years. Patient safety and adverse events will also be closely tracked throughout the study period.
CONDITIONS
Brief Title
A Study of AK117 in Combination With Azacitidine in Patients With Myelodysplastic Syndromes
Research Team
W
Wenting Li, MD
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