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IDH Mutant Targeted Therapy

IDH Mutant Targeted Therapies + Azacitidine for Acute Myeloid Leukemia

Phase 1 & 2
Waitlist Available
Research Sponsored by Celgene
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Newly diagnosed, primary (ie, de novo) or secondary (progression of Myelodysplastic syndrome [MDS] or myeloproliferative neoplasms [MPN], or therapy-related) acute myeloid leukemia (AML) according to the WHO classification with ≥ 20% leukemic blasts in the bone marrow
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

Study Summary

This trial will study two drugs, AG-120 and AG-221, in combination with azacitidine, to see if they are safe and effective in treating AML with IDH1 or IDH2 mutations.

Who is the study for?
This trial is for adults with a new diagnosis of acute myeloid leukemia (AML) that has IDH mutations and can't handle strong chemotherapy. They should be able to undergo regular bone marrow tests, have an ECOG performance status of 0-2, and not have had previous IDH-targeted treatments or certain types of AML.Check my eligibility
What is being tested?
The study is testing the safety and effectiveness of two drug combinations: AG-120 plus Azacitidine, and AG-221 plus Azacitidine. It aims to find the best doses when used together and compare them against using Azacitidine alone in treating AML with specific genetic changes.See study design
What are the potential side effects?
Possible side effects from these drugs may include nausea, vomiting, fatigue, liver problems like jaundice or elevated enzymes levels, nerve damage symptoms such as numbness or tingling sensations, diarrhea or constipation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with AML with more than 20% cancer cells in my bone marrow.
Select...
I can take care of myself and am up and about more than half of my waking hours.
Select...
I agree to have multiple bone marrow tests.

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 Response Rate: Phase 2 (Randomized Stage)
The Number of Participants Experiencing Adverse Events: Phase 1B (Dose Finding and Expansion Stage)
The Number of Participants Experiencing Dose-limiting Toxicities (DLTs): Phase 1B (Dose Finding Stage)
Secondary outcome measures
AUC (0-24)- Area Under the Plasma Concentration-Time Curve: Phase 2 (Randomized Stage)
AUC (0-8)- Area Under the Plasma Concentration-Time Curve: Phase 1B (Expansion Stage)
AUC (0-8)- Area Under the Plasma Concentration-Time Curve: Phase 2 (Randomized Stage)
+21 more

Side effects data

From 2021 Phase 3 trial • 187 Patients • NCT02989857
28%
Nausea
28%
Diarrhoea
23%
Fatigue
21%
Oedema peripheral
16%
Abdominal pain
16%
Anaemia
14%
Decreased appetite
14%
Weight decreased
12%
Vomiting
12%
Asthenia
12%
Cough
12%
Ascites
12%
Constipation
12%
Arthralgia
9%
Hypertension
9%
Abdominal pain upper
9%
Dizziness
9%
Muscle spasms
9%
Muscular weakness
9%
Dyspnoea
9%
Blood alkaline phosphatase increased
7%
Upper respiratory tract infection
7%
Hypoalbuminaemia
7%
Pruritus
7%
Hypophosphataemia
7%
Aspartate aminotransferase increased
7%
Alanine aminotransferase increased
7%
Insomnia
7%
Abdominal discomfort
5%
Hypokalaemia
5%
Rash
5%
Back pain
5%
White blood cell count decreased
5%
Hyperglycaemia
5%
Hyperkalaemia
5%
Pyrexia
5%
Headache
5%
Abdominal distension
5%
Blood bilirubin increased
5%
Confusional state
5%
Platelet count decreased
2%
Electrocardiogram QT prolonged
2%
Chills
2%
Cholangitis
2%
Gastrointestinal haemorrhage
2%
Intestinal pseudo-obstruction
2%
Biliary obstruction
2%
Bacteraemia
2%
Clostridium difficile colitis
2%
Escherichia bacteraemia
2%
Hip fracture
2%
Hypercalcaemia
2%
Encephalopathy
2%
Acute kidney injury
2%
Hypotension
2%
Gastrooesophageal reflux disease
2%
Hypomagnesaemia
2%
Blood creatinine increased
2%
Dyspepsia
2%
Urinary tract infection
2%
Rash maculo-papular
2%
Dry mouth
2%
Multiple sclerosis relapse
2%
Spinal cord compression
2%
Syncope
2%
Hyponatraemia
2%
Hepatic cirrhosis
2%
Oesophageal varices haemorrhage
2%
Upper gastrointestinal haemorrhage
100%
80%
60%
40%
20%
0%
Study treatment Arm
After Cross Over to AG-120
AG-120
Placebo

Trial Design

3Treatment groups
Experimental Treatment
Group I: AzacitidineExperimental Treatment1 Intervention
Group II: AG-221 + AzacitidineExperimental Treatment2 Interventions
Group III: AG-120 + AzacitidineExperimental Treatment2 Interventions
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
AG-221
2015
Completed Phase 1
~70

Find a Location

Who is running the clinical trial?

CelgeneLead Sponsor
632 Previous Clinical Trials
127,790 Total Patients Enrolled
Ira Gupta, MDStudy DirectorCelgene Corporation
Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb
1,499 Previous Clinical Trials
3,367,412 Total Patients Enrolled

Media Library

AG-120 (IDH Mutant Targeted Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02677922 — Phase 1 & 2
Acute Myeloid Leukemia Research Study Groups: AG-120 + Azacitidine, AG-221 + Azacitidine, Azacitidine
Acute Myeloid Leukemia Clinical Trial 2023: AG-120 Highlights & Side Effects. Trial Name: NCT02677922 — Phase 1 & 2
AG-120 (IDH Mutant Targeted Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02677922 — Phase 1 & 2

Frequently Asked Questions

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

Are there precedent studies on AG-120's efficacy?

"AG-120 is being trialed in 212 active studies, the majority of which are in Phase 3. 34 of these trials are taking place in Edmonton, Alberta, but there are a total of 6539 locations running AG-120 trials."

Answered by AI

At how many different places is this clinical trial being overseen?

"The list of institutions running this study includes the University of Chicago, Dana Farber Cancer Institute, City of Hope and 13 other locations."

Answered by AI

Are there any vacant slots in this particular clinical trial?

"This specific trial is not currently seeking patients, as denoted by its inactive status on clinicaltrials.gov. This page was created on 6/3/2016 and updated for the last time 8/18/2022; however, there are many other medical trials (1733 at present) that may be of interest."

Answered by AI

What are the conditions that AG-120 has been known to improve?

"AG-120 can be used to induction chemotherapy, refractory anemias, and leukemia, myelocytic, acute."

Answered by AI

How many people will be included in this clinical research project?

"This specific study is no longer seeking participants. Although, there are many other trials (1521 for leukemia, myeloid, acute and 212 for AG-120) that might be of interest and are currently admitting patients."

Answered by AI
Recent research and studies
~15 spots leftby Mar 2025