Actively Recruiting
Phase 2 Study of Chidamide and Duvalisib to Treat Relapsed or Resistant Peripheral T-cell Lymphoma in Adults
Led by The First Affiliated Hospital of Xiamen University · Updated on 2025-02-19
33
Participants Needed
1
Research Sites
51 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of combining Chidamide with Duvalisib to treat adults with refractory or relapsed peripheral T-cell lymphoma, a type of blood cancer. This Phase 2, open-label clinical trial focuses on measuring overall response rates, including complete and partial responses, as well as survival outcomes. The study aims to provide insights into how well this drug combination works and its side effects in patients who have not responded to previous treatments. Participants receive a specified dose of Chidamide combined with Duvalisib according to the trial schedule. The study is conducted as a single-arm trial without a placebo group, meaning all participants receive the combined treatment. The treatment period and dosing details are carefully monitored to assess the response to therapy over time. Throughout the study, participants will undergo regular evaluations including blood tests and imaging to measure tumor response and track side effects. Key outcomes like overall response rate and survival will be followed for up to 27 months. The trial also includes monitoring of safety and adverse effects to ensure participant well-being. The total duration for each participant depends on their response and study protocol adherence.
CONDITIONS
Brief Title
Chidamide and Duvalisibon for the Treatment of Refractory/Relapsed Peripheral T-cell Lymphoma
Research Team
B
Bing Xu
Z
Zhifeng Li
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