Ivosidenib + Azacitidine for Acute Myeloid Leukemia
(AGILE Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you must stop taking your current medications, but if you are on medications that prolong the QT interval (a heart rhythm measure), you may need to switch to other medications before starting the trial. It's best to discuss your current medications with the trial team.
What data supports the effectiveness of the drug combination Ivosidenib and Azacitidine for treating Acute Myeloid Leukemia?
Is the combination of Ivosidenib and Azacitidine safe for humans?
The combination of Ivosidenib and Azacitidine has been studied for safety in patients with acute myeloid leukemia (AML). Azacitidine has been used safely in patients with various blood disorders, and Ivosidenib is approved for AML with specific mutations, suggesting a safety profile that supports its use in humans.24567
What makes the drug combination of Ivosidenib and Azacitidine unique for treating acute myeloid leukemia?
What is the purpose of this trial?
This trial is testing a new oral drug, ivosidenib, combined with an injectable drug, azacitidine. It targets adults with a specific type of untreated leukemia who can't undergo intensive treatments. Ivosidenib blocks a faulty enzyme in cancer cells, and azacitidine stops these cells from growing.
Eligibility Criteria
This trial is for adults with previously untreated Acute Myeloid Leukemia (AML) who have an IDH1 mutation and are not suitable for intensive chemotherapy. They must have good liver and kidney function, agree to regular blood and bone marrow tests, understand the study, consent to it, and if of childbearing potential, use two forms of contraception.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive AG-120 or placebo in combination with azacitidine for a minimum of 6 cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- AG-120 (Ivosidenib)
- Azacitidine
- Placebo
Find a Clinic Near You
Who Is Running the Clinical Trial?
Institut de Recherches Internationales Servier
Lead Sponsor