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IDH2 Inhibitor

AG-221 for Acute Myeloid Leukemia (IDHENTIFY Trial)

Phase 3
Waitlist Available
Research Sponsored by Celgene
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subject has primary or secondary AML according to WHO classification
Subject has Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomization to 1 year after randomization
Awards & highlights

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.

Who is the study for?
This trial is for people aged 60 or older with acute myeloid leukemia (AML) that has returned or didn't respond to second- or third-line treatments. They must have an IDH2 mutation, be able to receive conventional care regimens, and have good enough health to participate in the study. Pregnant women, those with severe medical conditions, recent other cancer therapies, heart issues, uncontrolled infections or known allergies to study drugs cannot join.Check my eligibility
What is being tested?
The trial is testing AG-221 against standard treatments like Azacitidine and different doses of cytarabine in older patients with AML who carry an IDH2 mutation. It's a Phase 3 study where participants are randomly chosen to receive either AG-221 or one of the conventional care options.See study design
What are the potential side effects?
Possible side effects include reactions at the infusion site, gastrointestinal symptoms like nausea and vomiting, potential liver enzyme increases suggesting liver damage, fatigue, blood count abnormalities which can increase infection risk and bleeding problems.

IDHENTIFY Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My condition is classified as AML according to WHO standards.
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I can take care of myself and am up and about more than half of my waking hours.
Select...
I have undergone 2nd or 3rd treatment for acute myeloid leukemia.
Select...
My AML did not respond to or came back after 2nd or 3rd line treatment.
Select...
My cancer has a mutation in the IDH2 gene.
Select...
I am 60 years old or older.
Select...
My AML did not respond or has returned after 2nd or 3rd treatment.

IDHENTIFY Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization to 1 year after randomization
This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization to 1 year after randomization for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall Survival (OS)
Secondary outcome measures
Change From Baseline in EQ-5D-5L Health Utility Index
Change From Baseline in the European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire (EORTC QLQ-C30)
Complete Remission Rate
+16 more

Side effects data

From 2024 Phase 3 trial • 319 Patients • NCT02577406
43%
NAUSEA
39%
DIARRHOEA
32%
HYPOKALAEMIA
31%
DECREASED APPETITE
29%
THROMBOCYTOPENIA
28%
FATIGUE
28%
ANAEMIA
25%
BLOOD BILIRUBIN INCREASED
25%
VOMITING
24%
PYREXIA
20%
OEDEMA PERIPHERAL
20%
FEBRILE NEUTROPENIA
20%
DYSPNOEA
19%
CONSTIPATION
18%
ASTHENIA
17%
COUGH
17%
NEUTROPENIA
17%
EPISTAXIS
15%
DIZZINESS
15%
HEADACHE
15%
INSOMNIA
13%
BLOOD CREATININE INCREASED
13%
LEUKOCYTOSIS
12%
PAIN IN EXTREMITY
12%
BACK PAIN
11%
HYPERURICAEMIA
11%
SEPSIS
11%
ABDOMINAL PAIN
11%
HYPOMAGNESAEMIA
10%
PNEUMONIA
10%
HYPOCALCAEMIA
10%
STOMATITIS
10%
HYPERBILIRUBINAEMIA
10%
DIFFERENTIATION SYNDROME
9%
GENERAL PHYSICAL HEALTH DETERIORATION
9%
HYPOTENSION
8%
PETECHIAE
8%
WEIGHT DECREASED
8%
DYSGEUSIA
8%
HYPOALBUMINAEMIA
8%
LEUKOPENIA
8%
UPPER RESPIRATORY TRACT INFECTION
8%
URINARY TRACT INFECTION
8%
CONTUSION
8%
FALL
7%
HYPERGLYCAEMIA
7%
HAEMATOMA
7%
ARTHRALGIA
7%
MUSCULAR WEAKNESS
6%
DYSPEPSIA
6%
HYPONATRAEMIA
6%
HYPOPHOSPHATAEMIA
6%
LUNG INFECTION
6%
ABDOMINAL DISTENSION
6%
ABDOMINAL PAIN UPPER
6%
GINGIVAL BLEEDING
6%
MOUTH HAEMORRHAGE
6%
ORAL CANDIDIASIS
6%
CONFUSIONAL STATE
6%
PRURITUS
6%
RASH
6%
RASH MACULO-PAPULAR
5%
ANXIETY
5%
C-REACTIVE PROTEIN INCREASED
5%
OROPHARYNGEAL PAIN
5%
PLEURAL EFFUSION
5%
HYPERTENSION
4%
ASPARTATE AMINOTRANSFERASE INCREASED
4%
ACUTE MYELOID LEUKAEMIA
4%
ALANINE AMINOTRANSFERASE INCREASED
4%
SEPTIC SHOCK
4%
ERYTHEMA
3%
PNEUMONIA FUNGAL
3%
BLOOD ALKALINE PHOSPHATASE INCREASED
3%
DEHYDRATION
3%
HAEMORRHAGE INTRACRANIAL
3%
ACUTE KIDNEY INJURY
3%
SYNCOPE
3%
DRY EYE
3%
INFLUENZA LIKE ILLNESS
3%
RHINITIS
3%
BACTERAEMIA
3%
NON-CARDIAC CHEST PAIN
3%
INFECTION
3%
PANCYTOPENIA
3%
CLOSTRIDIUM DIFFICILE COLITIS
3%
CEREBRAL HAEMORRHAGE
3%
RESPIRATORY FAILURE
3%
CONJUNCTIVAL HAEMORRHAGE
3%
HAEMORRHOIDS
2%
RESPIRATORY DISTRESS
2%
MULTIPLE ORGAN DYSFUNCTION SYNDROME
2%
FEBRILE BONE MARROW APLASIA
2%
BRONCHITIS
2%
CELLULITIS
2%
PHARYNGITIS
2%
PERIPHERAL SENSORY NEUROPATHY
1%
TRANSAMINASES INCREASED
1%
RENAL IMPAIRMENT
1%
COLITIS
1%
VAGINAL HAEMORRHAGE
1%
PNEUMONITIS
1%
SKIN INFECTION
1%
NORMAL PRESSURE HYDROCEPHALUS
1%
TACHYCARDIA
1%
BRADYCARDIA
1%
BLAST CELL COUNT INCREASED
1%
ASCITES
1%
TUMOUR LYSIS SYNDROME
1%
SUBDURAL HAEMATOMA
1%
LOSS OF CONSCIOUSNESS
1%
PNEUMONIA INFLUENZAL
1%
LUNG DISORDER
1%
NECK PAIN
1%
HYPERKALAEMIA
1%
ACUTE MYELOID LEUKAEMIA RECURRENT
1%
EJECTION FRACTION DECREASED
1%
ISCHAEMIC STROKE
1%
DYSURIA
1%
TRANSFUSION REACTION
1%
HAEMORRHAGIC DISORDER
1%
ACUTE SINUSITIS
1%
SQUAMOUS CELL CARCINOMA OF SKIN
1%
RECTAL HAEMORRHAGE
1%
CARDIAC FAILURE
1%
ENTEROCOLITIS
1%
ENTEROCOLITIS HAEMORRHAGIC
1%
OESOPHAGITIS
1%
PNEUMONIA BACTERIAL
1%
STAPHYLOCOCCAL BACTERAEMIA
1%
DIABETIC METABOLIC DECOMPENSATION
1%
RESPIRATORY SYNCYTIAL VIRUS INFECTION
1%
RESPIRATORY TRACT INFECTION
1%
HYPERLEUKOCYTOSIS
1%
HEPATOSPLENIC CANDIDIASIS
1%
AGRANULOCYTOSIS
1%
LEUKAEMOID REACTION
1%
INFLUENZA
1%
ACUTE CORONARY SYNDROME
1%
ATRIAL FIBRILLATION
1%
ATRIAL FLUTTER
1%
CARDIAC ARREST
1%
CARDIAC FAILURE CONGESTIVE
1%
CARDIAC HYPERTROPHY
1%
CARDIOMYOPATHY
1%
CORONARY ARTERY DISEASE
1%
PERICARDIAL EFFUSION
1%
PERICARDITIS
1%
SINUS BRADYCARDIA
1%
KLEBSIELLA BACTERAEMIA
1%
ANGINA BULLOSA HAEMORRHAGICA
1%
CROHN'S DISEASE
1%
DIARRHOEA HAEMORRHAGIC
1%
GASTROINTESTINAL HAEMORRHAGE
1%
GINGIVAL HYPERTROPHY
1%
INGUINAL HERNIA
1%
LOWER GASTROINTESTINAL HAEMORRHAGE
1%
ODYNOPHAGIA
1%
UPPER GASTROINTESTINAL HAEMORRHAGE
1%
MALAISE
1%
MUCOSAL INFLAMMATION
1%
PHYSICAL DECONDITIONING
1%
CHOLANGITIS ACUTE
1%
CHOLELITHIASIS MIGRATION
1%
CHRONIC HEPATIC FAILURE
1%
HEPATIC FAILURE
1%
ENDOMETRIAL CANCER
1%
ONCOLOGIC COMPLICATION
1%
CAMPYLOBACTER INFECTION
1%
CLOSTRIDIAL SEPSIS
1%
ENTEROCOLITIS INFECTIOUS
1%
ENTEROCOCCAL INFECTION
1%
ESCHERICHIA BACTERAEMIA
1%
ESCHERICHIA SEPSIS
1%
ESCHERICHIA URINARY TRACT INFECTION
1%
MENINGITIS LISTERIA
1%
GASTROENTERITIS
1%
GASTROINTESTINAL INFECTION
1%
GINGIVITIS
1%
MUCORMYCOSIS
1%
NEUTROPENIC SEPSIS
1%
NOCARDIA SEPSIS
1%
NOCARDIOSIS
1%
OTITIS EXTERNA
1%
PERIORBITAL CELLULITIS
1%
PERIRECTAL ABSCESS
1%
PNEUMONIA LEGIONELLA
1%
PSEUDOMONAS INFECTION
1%
PULMONARY MYCOSIS
1%
PYELONEPHRITIS ACUTE
1%
STAPHYLOCOCCAL SEPSIS
1%
STENOTROPHOMONAS INFECTION
1%
SUBCUTANEOUS ABSCESS
1%
URINARY TRACT INFECTION ENTEROCOCCAL
1%
VASCULAR DEVICE INFECTION
1%
FEMUR FRACTURE
1%
INFUSION RELATED REACTION
1%
OVERDOSE
1%
POST PROCEDURAL HAEMORRHAGE
1%
SUBDURAL HAEMORRHAGE
1%
GENERAL PHYSICAL CONDITION ABNORMAL
1%
LIVER FUNCTION TEST INCREASED
1%
PLATELET COUNT DECREASED
1%
BONE PAIN
1%
JOINT EFFUSION
1%
TENDONITIS
1%
ACUTE LEUKAEMIA
1%
ACUTE LYMPHOCYTIC LEUKAEMIA
1%
DYSARTHRIA
1%
INTRAVENTRICULAR HAEMORRHAGE
1%
LUMBOSACRAL RADICULOPATHY
1%
RENAL COLIC
1%
LUNG INFILTRATION
1%
ORGANISING PNEUMONIA
1%
ECCHYMOSIS
1%
PURPURA
1%
RASH GENERALISED
1%
TOXIC SKIN ERUPTION
1%
HAEMORRHAGE
1%
DRY MOUTH
1%
MELAENA
1%
TOOTH INFECTION
1%
CHRONIC KIDNEY DISEASE
1%
PHLEBITIS
1%
OESOPHAGEAL ULCER
1%
TOOTH ABSCESS
1%
ATAXIA
100%
80%
60%
40%
20%
0%
Study treatment Arm
AG-221
BSC Only
Azacitidine + BSC
LDAC + BSC
IDAC + BSC

IDHENTIFY Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: AG-221 plus Best supportive care (BSC)Experimental Treatment2 Interventions
Continuous 28-day cycles of AG 221 100 mg orally (PO) once a day (QD) for 28 days, plus BSC.
Group II: Conventional care regimen (CCR)Active Control4 Interventions
Continuous 28-day cycles of BSC only, azacitidine subcutaneously (SC) plus BSC, low-dose cytarabine (LDAC) SC plus BSC, or intermediate-dose cytarabine (IDAC) intravenously (IV) plus BSC. Subjects will be assigned by the investigator to one of the CCR treatment options based on the investigator's assessment of subjects' eligibility.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AG-221
2015
Completed Phase 3
~390

Find a Location

Who is running the clinical trial?

CelgeneLead Sponsor
636 Previous Clinical Trials
128,535 Total Patients Enrolled
Patricia Martin, MDStudy DirectorCelgene Corporation
Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb
1,508 Previous Clinical Trials
3,370,104 Total Patients Enrolled

Media Library

AG-221 (IDH2 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02577406 — Phase 3
Myeloid Leukemia Research Study Groups: Conventional care regimen (CCR), AG-221 plus Best supportive care (BSC)
Myeloid Leukemia Clinical Trial 2023: AG-221 Highlights & Side Effects. Trial Name: NCT02577406 — Phase 3
AG-221 (IDH2 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02577406 — Phase 3

Frequently Asked Questions

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

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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"

Answered by AI
Recent research and studies
clinicaltrials.govStudy
An Efficacy and Safety Study of AG-221 (CC-90007) Versus Conventional Care Regimens in Older Subjects With Late Stage Acute Myeloid Leukemia Harboring an Isocitrate Dehydrogenase 2 Mutation
2015. "An Efficacy and Safety Study of AG-221 (CC-90007) Versus Conventional Care Regimens in Older Subjects With Late Stage Acute Myeloid Leukemia Harboring an Isocitrate Dehydrogenase 2 Mutation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02577406.
~34 spots leftby May 2025
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