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IDH1 Inhibitor

Ivosidenib + Azacitidine for Acute Myeloid Leukemia (AGILE Trial)

Phase 3
Waitlist Available
Research Sponsored by Institut de Recherches Internationales Servier
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be ≥ 18 years of age
Have previously untreated AML with ≥ 20% leukemic blasts in the bone marrow
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 52 months
Awards & highlights

AGILE Trial Summary

This trial is testing a new drug, AG-120, to see if it can help people with a certain type of leukemia who have not been treated before. The trial will compare AG-120 to a placebo, given with a standard treatment, azacitidine. The study will measure how well the participants do in terms of survival and response to treatment.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Possible side effects include issues affecting the heart rhythm or electrical activity (QT interval changes), allergic reactions to medication components, infection risks due to weakened immune system from leukemia or its treatments, as well as general drug-related side effects like nausea or fatigue.

AGILE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My leukemia has not been treated and my bone marrow shows a high number of cancer cells.
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My cancer has an IDH1 mutation.
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I can take care of myself and am up and about more than half of the day.

AGILE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 52 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 52 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Event-Free Survival (EFS)
Secondary outcome measures
CR + CRi (Including CRp) Rate
CR + Complete Remission With Partial Hematologic (CRh) Rate
Change From Baseline in the EORTC EQ-5D-5L Questionnaire
+29 more

AGILE Trial Design

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 .
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AG-120
2017
Completed Phase 3
~370
Azacitidine
2012
Completed Phase 3
~1440

Find a Location

Who is running the clinical trial?

Institut de Recherches Internationales ServierLead Sponsor
86 Previous Clinical Trials
69,415 Total Patients Enrolled

Media Library

AG-120 (Ivosidenib) (IDH1 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03173248 — Phase 3
Acute Myeloid Leukemia Research Study Groups: Placebo + Azacitidine, AG-120 + Azacitidine
Acute Myeloid Leukemia Clinical Trial 2023: AG-120 (Ivosidenib) Highlights & Side Effects. Trial Name: NCT03173248 — Phase 3
AG-120 (Ivosidenib) (IDH1 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03173248 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In how many distinct places is this investigation being carried out?

"4 sites are enrolling patients: Cancer Care Manitoba in Winnipeg, Massachusetts General Hospital in Boston, University Health Network in Toronto, and other locations."

Answered by AI

How often do negative side effects occur in patients when AG-120 (ivosidenib) is used in combination with Azacitidine?

"The safety of AG-120 (ivosidenib) in combination with azacitidine is estimated to be a 3. This is because it is a phase 3 trial, meaning that while there is data supporting efficacy, there are also multiple rounds of data supporting safety."

Answered by AI

Are AG-120 (ivosidenib) and Azacitidine often studied together in medical trials?

"AG-120 (ivosidenib) was first studied in 2006 in Hong Kong. As of now, there are 166 completed studies and 198 ongoing studies. Many of the recruiting trials are based in Winnipeg, Canada."

Answered by AI

What are the general benefits that AG-120 (ivosidenib) with Azacitidine provides?

"AG-120 (ivosidenib) with Azacitidine is often used as part of induction chemotherapy. It can also help patients with refractory anemias, leukemia, myelocytic, acute, multilineage dysplasia."

Answered by AI
~19 spots leftby Mar 2025