Study of Chiglitazar Sodium Combined With Venetoclax and Azacitidine for Adults with Relapsed or Refractory Acute Myeloid Leukemia

What this Trial Is About

Researchers are evaluating the safety and effectiveness of a treatment regimen called CVA, which combines Chiglitazar Sodium with Venetoclax and Azacitidine, for patients with refractory or relapsed acute myeloid leukemia RR AML. This phase 1, multicenter, single-arm clinical study aims to understand how well this combination works in patients who have not responded to previous treatments or whose disease has returned. The treatment involves taking Sogletanib at 48 mg once daily, Venetoclax at 400 mg once daily for 4 weeks, and Azacitidine at 100 mg daily on days 1 through 7 in 28-day cycles, with at least 2 cycles planned. Venetoclax dosage may be adjusted based on blood concentration one week after starting. Patients with stable or progressive disease after 2 cycles may receive up to 1 or 2 additional cycles. If no improvement occurs, patients may leave the study and consider other treatments such as stem cell transplantation. Hydroxyurea may be used to lower high white blood cell counts before starting Venetoclax if needed. Participants will undergo regular assessments during the study, including monitoring blood levels of Venetoclax, clinical evaluations, and laboratory tests to track response to treatment. Researchers will measure outcomes such as complete remission rate, complete remission with incomplete blood count recovery, and partial remission over a period of up to 36 months. The study is sponsored by The First Affiliated Hospital of Xiamen University and will run until the end of 2026.

Chiglitazar Sodium Combined With Venetoclax and Azacitidine (CVA) for the Treatment of R/R AML