Ivosidenib + Azacitidine for Acute Myeloid Leukemia
(AGILE Trial)

Recruiting in Palo Alto (17 mi)

+162 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Institut de Recherches Internationales Servier

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

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

+8 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.

+15 more

Participant Groups

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.

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 .