Phase IbII Study of Clifutinib Besylate with Chemotherapy for Adults Newly Diagnosed with Acute Myeloid Leukemia

What this Trial Is About

Researchers are evaluating the safety, tolerability, and effectiveness of Clifutinib Besylate combined with chemotherapy in adults newly diagnosed with acute myeloid leukemia AML. This open, multi-center clinical trial aims to explore appropriate dosing through dose escalation and to study drug interactions and gene changes related to treatment response. The study also investigates pharmacokinetic properties and correlations between AML subtypes and outcomes. Participants receive Clifutinib Besylate combined with either DA chemotherapy Daunorubicin and Cytarabine or AZA Azacitidine. Different dosing schedules are tested Clifutinib Besylate is given once daily at doses of 30mg, 40mg, or 60mg, with DA treatment on days 1 to 7 or AZA on days 1 to 7 depending on the group. Treatment includes induction, consolidation, and maintenance phases, with oral Clifutinib continued until disease progression or unacceptable side effects. Throughout the study, participants undergo safety and efficacy assessments including monitoring of the maximum tolerated dose, complete remission rates, response duration, and survival up to 12 months. Researchers also collect data on pharmacokinetics and gene changes before and after treatment. The total participation time varies, with ongoing treatment and follow-up visits to evaluate outcomes and monitor for adverse effects.

A Phase Ⅰb/Ⅱ Clinical Study of Clifutinib Besylate Combined With Chemotherapy in the Treatment of Newly Diagnosed AML