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Ivosidenib + Azacitidine for Acute Myeloid Leukemia (AGILE Trial)
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.
AGILE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowAGILE Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.AGILE Trial Design
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Who is running the clinical trial?
Media Library
- 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.I am willing and able to undergo strong chemotherapy for my AML.I have been cancer-free for over a year, except for MDS or myeloproliferative disorder.I am experiencing severe, life-threatening complications from leukemia.I can switch from or be monitored for my QT-prolonging medication before the study.I have been diagnosed with progressive multifocal leukoencephalopathy.I have been treated with an IDH1 inhibitor before.I have had serious heart problems in the last 6 months.I have symptoms or a diagnosis of leukemia in my brain or spinal cord.My cancer has an IDH1 mutation.My kidneys are working well.I have trouble swallowing or absorbing pills.I am 18 years old or older.I am not eligible for intensive chemotherapy due to my age, health condition, or specific medical issues.My leukemia has not been treated and my bone marrow shows a high number of cancer cells.I have an ongoing infection that hasn't improved with treatment.My liver is working well.I have been treated for AML, but only with hydroxyurea.I can take care of myself and am up and about more than half of the day.I have a condition that could affect my heart's rhythm.
- Group 1: Placebo + Azacitidine
- Group 2: AG-120 + Azacitidine
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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