A Study to Investigate the Effect of Adding Venetoclax to a Treatment with Ivosidenib and Azacitidine in Patients with Acute Myeloid Leukemia (AML) with a Specific Genetic Anomaly Who Have Not Been Previously Treated and Are Not Eligible for Intensive Chemotherapy

The treatment of patients with newly diagnosed AML who are not eligible for intensive chemotherapy remains inadequate. Typically, a combination therapy of two agents, namely Azacitidine and Ivosidenib, is administered. This has already led to significant advances in treatment, but it still does not provide a cure, and the disease returns over time. The current study investigates whether the addition of Venetoclax to the combination therapy improves treatment outcomes in AML patients with a mutation in the IDH1 gene.
Patients will be randomly assigned to one of two study groups (this is done without your knowledge of which group you are in).
One of the two groups will receive Venetoclax in addition to the therapy with Azacitidine and Ivosidenib. All three medications have already been approved for the treatment of different tumors but have not been tested in combination with Venetoclax.
This study aims to investigate whether the addition of Venetoclax improves survival and cure rates; whether the therapy responds more quickly as a result, or whether the therapy lasts longer.

Initial examination:

• Assessment of your medical history
• Examination of your physical condition
• Blood draw and urine sample (for blood count and liver values; to determine existing infections)
• ECG (electrocardiogram, assessment of heart function)
• Bone marrow puncture

During the study:

• Examination of your physical condition
• Blood draws (to monitor your blood values during therapy)
• Documentation of any adverse side effects that occur

acute myeloid leukemia (AML)