Ivosidenib + Azacitidine + Venetoclax for Acute Myeloid Leukemia
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a combination of three drugs—ivosidenib, azacitidine, and venetoclax—to determine their effectiveness in treating acute myeloid leukemia (AML) with an IDH mutation. After initial treatment, participants will continue with ivosidenib alone to prevent cancer recurrence. The study also evaluates the treatment's safety and the time commitment required from participants. Individuals recently diagnosed with AML and a positive IDH mutation test may be suitable for this trial. As a Phase 2 trial, it measures the treatment's effectiveness in a smaller group, allowing participants to contribute to important research.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it does allow the use of hydroxyurea to manage white blood cell counts. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that combining ivosidenib, azacitidine, and venetoclax is generally safe for patients with acute myeloid leukemia (AML) who have an IDH mutation. Studies have found this 3-drug mix to be both safe and effective, with patients experiencing lasting positive effects. One study found that using ivosidenib with venetoclax, and sometimes azacitidine, resulted in a 3-year survival rate of 71%. This indicates that the treatment is well-tolerated over the long term. These findings offer promise for those considering this treatment option in a clinical trial.12345
Why are researchers excited about this trial's treatments?
Researchers are excited about combining Ivosidenib, Azacitidine, and Venetoclax for treating Acute Myeloid Leukemia because it targets the cancer cells in a novel way. Ivosidenib specifically targets IDH1 mutations, a common mutation in this type of leukemia, which is different from the broad-acting chemotherapy used in standard treatments. Additionally, Venetoclax helps make cancer cells more vulnerable to dying, enhancing the effectiveness of the combination. This targeted approach not only has the potential to improve outcomes but also to reduce some of the side effects associated with traditional chemotherapy.
What evidence suggests that this trial's treatments could be effective for acute myeloid leukemia?
Research shows that a combination of three drugs—ivosidenib, azacitidine, and venetoclax—may be promising for treating acute myeloid leukemia (AML) with an IDH mutation. In this trial, participants will initially receive all three drugs, followed by ivosidenib alone. Studies have found that patients treated with these drugs have a notably high survival rate over three years. Specifically, 30% of patients with the IDH1 mutation in their AML experienced a significant reduction or elimination of cancer cells. Ivosidenib targets the IDH1 mutation, azacitidine acts as a chemotherapy drug, and venetoclax aids in killing cancer cells. Together, these drugs have been linked to better outcomes, suggesting they may effectively manage AML with this specific genetic mutation.24567
Who Is on the Research Team?
Kuo-Kai Chin, MD
Principal Investigator
Memorial Sloan Kettering Cancer Center
Are You a Good Fit for This Trial?
This trial is for people aged 60 or older with newly diagnosed acute myeloid leukemia (AML) that has an IDH mutation. They should be able to follow the study schedule, have acceptable liver function tests, and a white blood cell count below 25,000/μL. Those who are too weak (with ECOG performance status over 3), or don't meet other health criteria can't join.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a combination of ivosidenib, azacitidine, and venetoclax for initial treatment
Maintenance Therapy
Participants receive maintenance therapy with ivosidenib alone to prevent cancer recurrence
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Azacitidine
- Ivosidenib
- Venetoclax
Trial Overview
The study is testing if combining Ivosidenib, Azacitidine, and Venetoclax followed by just Ivosidenib works well as a treatment for AML with an IDH mutation. It looks at effectiveness in preventing cancer return after initial success and assesses safety and time commitment for participants.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Patients will be initially treated with 7 days of azacitidine (IV or SC per institutional preference, 14 days of venetoclax and 14 days of Ivosidenib daily, days 15 through 28 for cycle 1, then days 1 through 28 for each cycle thereafter).
Find a Clinic Near You
Who Is Running the Clinical Trial?
Memorial Sloan Kettering Cancer Center
Lead Sponsor
Servier Pharmaceuticals, LLC
Collaborator
Citations
1.
ashpublications.org
ashpublications.org/blood/article/146/Supplement%201/8249/553653/Ivosidenib-combined-with-venetoclax-andIvosidenib combined with venetoclax and azacitidine for the ...
Recently, data have been disclosed showing the treatment efficacy of Ivosidenib(IVO)+Venetoclax(VEN) ± Azacitidine(AZA), with a 3-year survival rate reaching ...
Ivosidenib combined with venetoclax and azacitidine for ...
Recently, data have been disclosed showing the treatment efficacy of Ivosidenib(IVO)+Venetoclax(VEN) ± Azacitidine(AZA), with a 3-year survival ...
Long-term results from the AGILE study of azacitidine plus ...
Among patients with mutant IDH1 AML in complete remission with ivosidenib-azacitidine, 30% experienced deep molecular clearance on treatment. Visual Abstract.
Study Examines Real-World Outcomes With Ivosidenib vs ...
Treatment with the IDH1-targeted agent ivosidenib plus a hypomethylating agent was associated with better outcomes than venetoclax plus a hypomethylating agent.
219 A Phase Ib/II Study of Ivosidenib with Venetoclax ± ...
Pts who received SCT had a 3-year OS of 94.7% (95% CI: 85.2 – 100%) compared to 52.8% (25.6 – 78.2%) in those who did not. For MDS or MPN (n=12) ...
Ivosidenib or venetoclax combined with hypomethylating ...
In this real-world study of patients with mIDH1 ND-AML, IVO+HMA vs VEN+HMA improved CR, time to response, and event-free survival. •. With enhanced efficacy and ...
Long-term results from the AGILE study of azacitidine plus ...
In long-term follow-up, ivosidenib-azacitidine, with a median OS of 29.3 months, sustained survival and hematologic benefits in mutant IDH1 AML.
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