Ivosidenib + Venetoclax +/- Azacitidine for Leukemia
Trial Summary
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify if you must stop taking your current medications, but you cannot use other chemotherapeutic or anti-leukemic agents during the study, except for certain exceptions like intrathecal chemotherapy or hydroxyurea. Also, you should not take strong CYP3A inducers within 3 days of starting the study therapy.
What data supports the effectiveness of the drug combination Ivosidenib, Venetoclax, and Azacitidine for treating leukemia?
Venetoclax combined with azacitidine is used as a first-line therapy for elderly patients with acute myeloid leukemia (AML), achieving a complete remission rate of 70% or more. Additionally, venetoclax has shown high response rates in chronic lymphocytic leukemia (CLL), indicating its potential effectiveness in blood cancers.12345
Is the combination of Ivosidenib, Venetoclax, and Azacitidine safe for humans?
Venetoclax, when used with azacitidine, has shown an acceptable safety profile in patients with acute myeloid leukemia and chronic lymphocytic leukemia, with manageable side effects like neutropenia (low white blood cell count). Common side effects include blood-related and digestive issues, but these are generally manageable with supportive care and dose adjustments.12367
What makes the drug combination of Ivosidenib, Venetoclax, and Azacitidine unique for treating leukemia?
This drug combination is unique because it includes Ivosidenib, which targets a specific genetic mutation (IDH1) in leukemia cells, alongside Venetoclax and Azacitidine, which are already used together for older patients with acute myeloid leukemia who cannot undergo standard chemotherapy. This combination may offer a new option for patients with specific genetic profiles.12458
What is the purpose of this trial?
This phase Ib/II trial studies the side effects and best dose of venetoclax and how well it works when given together with ivosidenib with or without azacitidine, in treating patients with IDH1-mutated hematologic malignancies. Venetoclax and ivosidenib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ivosidenib and venetoclax with azacitidine may work better in treating patients with hematologic malignancies compared to ivosidenib and venetoclax alone.
Research Team
Courtney DiNardo, MD
Principal Investigator
M.D. Anderson Cancer Center
Eligibility Criteria
This trial is for patients with IDH1-mutated blood cancers like AML, MDS, or MPN who are either treatment-naive and ineligible for standard chemotherapy or have relapsed/refractory disease. Participants must be in stable condition with acceptable organ function and agree to contraception. Those previously treated with ivosidenib/venetoclax, active infections (HBV/HCV/HIV), uncontrolled medical conditions, severe allergies to study drugs, or on certain medications are excluded.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive venetoclax orally daily on days 1-14, ivosidenib orally daily on days 15-28 of cycle 1 and days 1-28 of subsequent cycles, and may receive azacitidine intravenously or subcutaneously on days 1-7. Cycles repeat every 28 days.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion, with follow-up at 30 days and then monthly for 3 years.
Treatment Details
Interventions
- Azacitidine
- Ivosidenib
- Venetoclax
Ivosidenib is already approved in United States, European Union for the following indications:
- Acute myeloid leukemia (AML) with IDH1 mutation
- Acute myeloid leukemia (AML) with IDH1 mutation
Find a Clinic Near You
Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
Lead Sponsor