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AG-221 for Acute Myeloid Leukemia (IDHENTIFY Trial)
IDHENTIFY Trial Summary
This trial is testing a new drug, AG-221, against conventional care regimens (CCRs) for subjects 60 years or older with AML who have relapsed after second- or third-line therapy.
IDHENTIFY Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowIDHENTIFY Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.IDHENTIFY Trial Design
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Who is running the clinical trial?
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- I haven't had cancer treatment or radiation in the last 2 weeks.I have or might have leukemia affecting my brain or spinal cord.My leukemia is causing severe, life-threatening complications.I have had serious heart problems in the last 6 months.I am diagnosed or suspected to have acute promyelocytic leukemia.I haven't taken any non-chemotherapy cancer drugs or experimental treatments in the last 14 days.My condition is classified as AML according to WHO standards.I can take care of myself and am up and about more than half of my waking hours.My organs are functioning well.I have undergone 2nd or 3rd treatment for acute myeloid leukemia.I have been treated with a drug for an IDH2 mutation.My AML did not respond to or came back after 2nd or 3rd line treatment.My cancer has a mutation in the IDH2 gene.I agree to use the specified methods of contraception.I am 60 years old or older.I have an ongoing severe infection that isn't under control.My AML did not respond or has returned after 2nd or 3rd treatment.I still have serious side effects from past treatments.I had cancer before, but have been cancer-free for at least a year.My AML developed from chronic myelogenous leukemia.I am a woman who can have children and meet the study's specific conditions.I had a stem cell transplant less than 60 days ago.I am willing and able to receive the chosen CCR treatment.
- Group 1: Conventional care regimen (CCR)
- Group 2: AG-221 plus Best supportive care (BSC)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Are there other examples of AG-221's efficacy?
"AG-221 is being researched in 421 clinical trials, 87 of which are in the third phase. The majority of these trials are located in Edmonton, Alberta; however, there are 14502 total locations running trials for AG-221."
What medical ailment is AG-221 most often used to treat?
"AG-221 is a medication used to treat meningeal leukemia, but can also be helpful for patients with other blood disorders like refractory anemias and blast phase chronic myelocytic leukemia."
Are patients currently being accepted for this trial?
"This particular study is no longer recruiting patients, as it was last updated on October 19th, 2022. If you're looking for other opportunities, there are 1,514 trials for isocitrate dehydrogenase and 421 for AG-221 that are still actively searching for participants."
How many test subjects are involved in this research?
"Presently, this trial is not seeking any more participants as it is closed to recruitment. This study was first posted on December 30th, 2015 but was last edited on October 19th, 2022. If you are interested in other trials, there are 1514 trials involving isocitrate dehydrogenase and 421 involving AG-221 that are actively recruiting."
What is the status of AG-221 in terms of government regulation?
"AG-221's safety is supported by efficacy data from Phase 3 trials as well as additional safety data from follow-up studies-- making it a 3 on our Power scale."
Is this study widely available in North America?
"In addition to 33 other sites, this trial is also currently enrolling patients at Cancer Care Manitoba, Cancer Center of the Carolinas, and Roswell Park Cancer Institute."
What are the goals that this research is looking to achieve?
"The goal of this clinical trial is to measure overall survival, which will be observed over the course of approximately 49 months. Secondary outcomes being observed include Event-Free Survival, which is defined as the time from randomization to documented relapse after complete remission/complete remission with incomplete neutrophil recovery/complete remission with incomplete platelet recovery (CR/CRi/CRp), progressive disease (PD), or death from any cause – whichever occurs first. Morphologic relapse after CR/CRi/CRp is defined as either reappearance of ≥ 5% blasts in the bone marrow not attributable to any other cause, or the development"
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