Study of VA-CIG Chemotherapy Regimen for Adults 18 to 70 with Untreated Acute Myeloid Leukemia

What this Trial Is About

Researchers are evaluating the VA-CIG regimen, which combines venetoclax, azacitidine, idarubicin, low-dose cytarabine, and granulocyte colony-stimulating factor G-CSF, as an induction therapy for patients with previously untreated acute myeloid leukemia AML who are eligible for intensive chemotherapy. This is a multicenter, prospective, single-arm Phase 2 clinical trial designed to assess the safety and effectiveness of this combination treatment in adults aged 18 to 70 years with fit AML. Participants receive the VA-CIG chemotherapy regimen, which includes venetoclax taken orally with a dose escalation over the first days, azacitidine given as a subcutaneous injection for seven days, cytarabine and idarubicin administered intravenously over several days, and G-CSF injected subcutaneously from the day before treatment until white blood cell counts reach a specified level. Each treatment cycle lasts 28 days, and patients are monitored throughout the therapy. During the study, participants will undergo regular assessments including evaluation of treatment response after the first 28-day cycle, with measures such as the combined complete response rate and minimal residual disease remission. Safety is monitored closely from treatment start until two weeks after therapy ends. Other evaluations include blood tests, heart function measurements, and performance status assessments to ensure participants tolerate the intensive regimen. The study participation period extends up to the end of treatment and follow-up assessments.

VA-CIG Regimen for Previously Untreated Acute Myeloid Leukemia: A Multicenter Prospective Single-Arm Trial