Study of Ivosidenib with Venetoclax and Azacitidine for Adults with Newly Diagnosed IDH1 Mutation Acute Myeloid Leukemia

What this Trial Is About

Researchers are evaluating the safety and effectiveness of a combination treatment using ivosidenib, venetoclax, and azacitidine in adult Chinese patients newly diagnosed with IDH1 mutation acute myeloid leukemia AML. This phase 2, single-arm, open-label trial involves about 42 participants across multiple centers in China. The study aims to measure how well this combination induces complete remission and partial hematologic recovery, along with other outcomes like event-free survival and overall survival. Participants receive combination therapy in two groups those considered fit and those unfit for intensive treatment. Ivosidenib is taken orally daily starting from day 15 of the first 28-day cycle and continues daily thereafter. Venetoclax is given orally with a dose escalation in the first cycle and then daily for 14 days of each subsequent cycle. Azacitidine is administered by injection daily for seven days in each 28-day cycle. Fit participants undergo at least 2 cycles, while unfit participants receive a minimum of 6 cycles unless certain conditions like relapse, disease progression, unacceptable side effects, pregnancy, withdrawal, or study completion occur. Throughout the trial, participants will be monitored regularly to assess treatment response, including complete remission rates at one year, event-free survival, overall survival, and objective response rates. Blood and bone marrow samples will be collected periodically. Participants will also complete quality of life assessments during and after treatment. The study includes safety monitoring and requires informed consent, with careful follow-up to evaluate the treatments effects over time.

a New Treatment of Newly Diagnosed IDH1 Mutation Acute Myeloid Leukemia