Study of Bugitinib with Venetoclax and Cytarabine for Adults 18 to 70 Years with Relapsed or Refractory Non-M3 Acute Myeloid Leukemia

What this Trial Is About

Researchers are evaluating the combination of Bugitinib, Venetoclax, and Cytarabine in adults with relapsed or refractory acute myeloid leukemia AML, excluding the M3 subtype. This exploratory study aims to assess the rate and duration of minimal residual disease MRD negativity after treatment. Secondary goals include measuring overall response, survival rates, disease progression, and safety of the treatment combination. Participants will receive induction therapy with Bugitinib and Venetoclax taken orally daily for 28 days, combined with Cytarabine given intravenously for 7 to 10 days per cycle. If complete remission is not achieved after the first cycle, a second cycle with adjusted Cytarabine dosing may be given. Treatment decisions will be guided by MRD and bone marrow assessments, with supportive care provided as needed. Throughout the study, participants will undergo regular bone marrow and MRD testing to evaluate treatment response. Safety and tolerability will be closely monitored during therapy. The study includes follow-up assessments for up to two years to track the duration of MRD negativity and other outcomes. Participants must be adults aged 18 to 70 years with specific AML criteria and adequate organ function to take part in this research.

Bugitinib Combined With Venetoclax and Cytarabine in Relapsed/Refractory Acute Myeloid Leukemia