146 Participants Needed

Ivosidenib + Azacitidine for Acute Myeloid Leukemia

(AGILE Trial)

Recruiting at 162 trial locations
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Institut de Recherches Internationales Servier
Must be taking: Azacitidine
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

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?

Research shows that combining Ivosidenib with Azacitidine significantly improves survival rates and remission in patients with acute myeloid leukemia who have an IDH1 mutation, compared to using Azacitidine alone.12345

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?

The combination of Ivosidenib and Azacitidine is unique because it specifically targets acute myeloid leukemia with an IDH1 mutation, improving survival rates and remission compared to Azacitidine alone, especially in patients who cannot undergo intensive chemotherapy.12345

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

Be able to understand and willing to sign an informed consent form (ICF)
Be willing to complete Quality of Life assessments during the study
If female with reproductive potential, must have a negative serum pregnancy test prior to the start of study therapy. Females of reproductive potential, as well as fertile men and their female partners of reproductive potential, must agree to use 2 effective forms of contraception
See 7 more

Exclusion Criteria

I am currently pregnant or breastfeeding.
I have been treated with a drug to modify my DNA for MDS.
I have waited the required time after my last dose of an experimental MDS treatment.
See 15 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive AG-120 or placebo in combination with azacitidine for a minimum of 6 cycles

24 weeks
Monthly visits for each 28-day cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 52 months

Treatment Details

Interventions

  • AG-120 (Ivosidenib)
  • Azacitidine
  • Placebo
Trial Overview The trial is testing AG-120 (Ivosidenib) combined with Azacitidine against a placebo plus Azacitidine in patients with AML. It's a global Phase 3 study where participants are randomly assigned to either treatment group. The main goal is to see how long patients live without their disease getting worse.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: AG-120 + AzacitidineExperimental Treatment2 Interventions
Participants received AG-120 500 mg orally, once daily (QD) in combination with azacitidine 75 milligrams per square meter per day (mg/m\^2/day) subcutaneously (SC) or intravenously (IV), on Days 1-7, or on Days 1-5 and 8-9, of each 28-day cycle for a minimum of 6 cycles until death, disease relapse, disease progression, development of unacceptable toxicity (adverse event), confirmed pregnancy, withdrawal by participant or protocol violation.
Group II: Placebo + AzacitidinePlacebo Group2 Interventions
Participants received AG-120 matching placebo orally, QD in combination with azacitidine 75 mg/m\^2/day SC or IV, on Days 1-7, or on Days 1-5 and 8-9, of each 28-day cycle for a minimum of 6 cycles until death, disease relapse, disease progression, development of unacceptable toxicity (adverse event), confirmed pregnancy, withdrawal by participant or protocol violation .

Find a Clinic Near You

Who Is Running the Clinical Trial?

Institut de Recherches Internationales Servier

Lead Sponsor

Trials
91
Recruited
67,100+

Findings from Research

A phase III study demonstrated that combining azacitidine with the IDH1 inhibitor ivosidenib significantly improves treatment outcomes for patients with acute myeloid leukemia who cannot undergo intensive chemotherapy.
The combination therapy tripled overall survival rates and enhanced complete remission and event-free survival compared to azacitidine alone, indicating a substantial efficacy boost from this drug pairing.
Ivosidenib Boosts OS with Azacitidine in AML.[2022]
Ivosidenib, when combined with azacitidine, significantly improves event-free survival and overall survival in older adults or those with comorbidities suffering from IDH1-mutated acute myeloid leukemia, as shown in a phase 3 study with improved survival rates (HR 0.35 and HR 0.44).
The combination therapy also resulted in a higher complete remission rate (47% vs. 15% with placebo) and maintained a safety profile similar to ivosidenib alone, with notable adverse effects including differentiation syndrome and QT interval prolongation.
FDA Approval Summary: Ivosidenib in Combination with Azacitidine for Treatment of Patients with Newly Diagnosed Acute Myeloid Leukemia with an IDH1 Mutation.Woods, A., Norsworthy, KJ., Wang, X., et al.[2023]
In a phase Ib trial involving 23 patients with newly diagnosed IDH1-mutant acute myeloid leukemia, the combination of ivosidenib and azacitidine resulted in a high overall response rate of 78.3% and a complete remission rate of 60.9%.
The treatment was well tolerated, with a safety profile similar to that of each drug alone, and 71.4% of patients achieving complete remission showed clearance of the mIDH1 mutation in their bone marrow.
Mutant Isocitrate Dehydrogenase 1 Inhibitor Ivosidenib in Combination With Azacitidine for Newly Diagnosed Acute Myeloid Leukemia.DiNardo, CD., Stein, AS., Stein, EM., et al.[2022]

References

Ivosidenib Boosts OS with Azacitidine in AML. [2022]
FDA Approval Summary: Ivosidenib in Combination with Azacitidine for Treatment of Patients with Newly Diagnosed Acute Myeloid Leukemia with an IDH1 Mutation. [2023]
Ivosidenib and Azacitidine in IDH1-Mutated Acute Myeloid Leukemia. [2022]
Mutant Isocitrate Dehydrogenase 1 Inhibitor Ivosidenib in Combination With Azacitidine for Newly Diagnosed Acute Myeloid Leukemia. [2022]
Azacitidine access program for Belgian patients with myelodysplastic syndromes, acute myeloid leukemia or chronic myelomonocytic leukemia. [2018]
Safety and efficacy of azacitidine in Belgian patients with high-risk myelodysplastic syndromes, acute myeloid leukaemia, or chronic myelomonocytic leukaemia: results of a real-life, non-interventional post-marketing survey. [2015]
Impact of performance status and transfusion dependency on outcome of patients with myelodysplastic syndrome, acute myeloid leukemia and chronic myelomonocytic leukemia treated with azacitidine (PIAZA study). [2019]
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