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IDH Inhibitor

AG-120 or AG-221 Combination Therapy for Acute Myeloid Leukemia

Phase 1

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

Diagnosed with previously untreated AML (excluding APL) with locally documented IDH1 and/or IDH2 gene mutation scheduled for induction therapy followed by consolidation therapy

Adequate renal function as evidenced by specific criteria

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 26 weeks

Awards & highlights

Study Summary

This trial is studying AG-120 and AG-221 to see if they are safe when given with standard AML induction and consolidation therapy and to find the maximum tolerated dose of each drug.

Who is the study for?

Adults with newly diagnosed Acute Myeloid Leukemia (AML) having specific mutations (IDH1/IDH2), who haven't had AML treatment but may have been treated for related conditions. They should be in a stable health condition, not pregnant or breastfeeding, and willing to use effective contraception.Check my eligibility

What is being tested?

The trial is testing AG-120 or AG-221 combined with standard AML therapies during different phases of treatment. It aims to find the safest doses of these drugs when used with induction and consolidation therapy, followed by maintenance until relapse or unacceptable toxicity.See study design

What are the potential side effects?

Potential side effects include reactions at the infusion site, changes in liver and kidney function tests, gastrointestinal symptoms like nausea and vomiting, potential blood disorders such as anemia or clotting issues, fatigue, and increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have AML with an IDH mutation and haven't started treatment yet.

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My kidney function is within normal ranges.

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I am 18 years old or older.

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I can take care of myself and am up and about more than half of my waking hours.

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My liver is functioning well.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 26 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 26 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 26 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percentage of Participants with Adverse Events (AEs)

Secondary outcome measures

2-hydroxyglutarate (2-HG) Levels in Plasma

Clinical Activity of AG-120 and AG-221 According to the 2003 Revised International Working Group (IWG) Criteria for AML

Pharmacokinetics (PK) of AG-120 and AG-221 in Plasma when Administered with Induction and Consolidation Therapy

+1 more

Trial Design

6Treatment groups

Experimental Treatment

Group I: AG-221 with cytarabine and idarubicinExperimental Treatment5 Interventions

Daily AG-221 administered orally in combination with standard Induction therapy and consolidation therapy. After 1 cycle of induction therapy, participants may undergo a second induction cycle given as per institutional practice. Participants who achieve an adequate response at the end of induction therapy will go on to receive consolidation therapy (mitoxantrone/etoposide or up to 4 cycles of cytarabine) in combination with AG-221. Participants who complete consolidation therapy and are in CR or CRi (including CRp) may continue on maintenance therapy and receive daily treatment with AG-221.

Group II: AG-221 with cytarabine and daunorubicinExperimental Treatment5 Interventions

Group III: AG-221 (starting on Day 8) with cytarabine and idarubicinExperimental Treatment5 Interventions

Daily AG-221 administered orally starting on Day 8 of induction cycle 1 in combination with standard Induction therapy and consolidation therapy. After 1 cycle of induction therapy, participants may undergo a second induction cycle given as per institutional practice. Participants who achieve an adequate response at the end of induction therapy will go on to receive consolidation therapy (mitoxantrone/etoposide or up to 4 cycles of cytarabine) in combination with AG-221. Participants who complete consolidation therapy and are in CR or CRi (including CRp) may continue on maintenance therapy and receive daily treatment with AG-221.

Group IV: AG-221 (starting on Day 8) with cytarabine and daunorubicinExperimental Treatment5 Interventions

Group V: AG-120 with cytarabine and idarubicinExperimental Treatment5 Interventions

Daily AG-120 administered orally in combination with standard Induction therapy and consolidation therapy. After 1 cycle of induction therapy, participants may undergo a second induction cycle given as per institutional practice. Participants who achieve an adequate response at the end of induction therapy will go on to receive consolidation therapy (mitoxantrone/etoposide or up to 4 cycles of cytarabine) in combination with AG-120. Participants who complete consolidation therapy and are in CR or CRi (including CRp) may continue on maintenance therapy and receive daily treatment with AG-120.

Group VI: AG-120 with cytarabine and daunorubicinExperimental Treatment5 Interventions

Daily AG-120 administered orally in combination with standard Induction therapy and consolidation therapy. After 1 cycle of induction therapy, participants may undergo a second induction cycle given as per institutional practice. Participants who achieve an adequate response at the end of induction therapy will go on to receive consolidation therapy (mitoxantrone/etoposide or up to 4 cycles of cytarabine) in combination with AG-120. Participants who complete consolidation therapy and are in complete response (CR) or complete remission with incomplete hematologic recovery (CRi) (including CR with incomplete platelet recovery [CRp]) may continue on maintenance therapy and receive daily treatment with AG-120.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

AG-120

2017

Completed Phase 3

~370

cytarabine

1997

Completed Phase 3

~10270

daunorubicin

2005

Completed Phase 3

~2400

AG-221

2015

Completed Phase 1

~70

etoposide

1994

Completed Phase 3

~9300

idarubicin

2007

Completed Phase 3

~5130

mitoxantrone

2005

Completed Phase 4

~1960

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Institut de Recherches Internationales ServierLead Sponsor

86 Previous Clinical Trials

66,983 Total Patients Enrolled

Celgene CorporationIndustry Sponsor

444 Previous Clinical Trials

58,083 Total Patients Enrolled

Frequently Asked Questions

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

Are there any precedents for the use of AG-120 in prior clinical trials?

"Presently, there are 548 ongoing trials for the AG-120 treatment. Of those studies, 137 have reached Phase 3 and they are primarily located in Edmonton, Alberta. However, 24177 locations across the globe administer this medication as part of their research initiatives."

Answered by AI

What maladies can AG-120 be used to treat?

"AG-120 is the medication of choice when treating multiple sclerosis and has also shown to be beneficial in managing merkel cell cancer, meningeal leukemia, and prostate cancer."

Answered by AI

How many participants are actively involved in the experiment?

"At this moment, recruitment for this trial has ended. It was first posted on December 31st 2015 and the latest update is from July 26th 2022. If you are still looking to participate in clinical studies, there are 1655 trials actively enrolling participants with leukemia or myeloid acute and 548 AG-120 related studies seeking volunteers."

Answered by AI

Is this investigation being carried out in various areas of the city?

"This medical study is recruiting patients from a wide range of clinical sites, including MD Anderson Cancer Center in Houston, Texas; Ohio State University in Columbus, Ohio; and Massachusetts General Hospital in Boston, Massachusetts. A total of 14 other locations are also accepting participants."

Answered by AI

Has the Food and Drug Administration endorsed AG-120 as a safe therapeutic option?

"The safety of AG-120 has been tentatively assessed with a score of 1, as the drug is still in Phase 1 trials and evidence regarding its efficacy or potential harm remains limited."

Answered by AI

Is recruitment for this research currently taking place?

"This trial is no longer recruiting new patients, with its initial posting having been on December 31st 2015 and the most recent update being July 26th 2022. However, there are currently 1655 trials actively enrolling participants for leukemia, myeloid acute and 548 studies concerning AG-120 that remain open to registration."

Answered by AI

Recent research and studies

BloodJournal

Ivosidenib or Enasidenib Combined with Intensive Chemotherapy in Patients with Newly Diagnosed AML: A Phase 1 Study

Stein, Eytan M., Courtney D. DiNardo, Amir T. Fathi, Alice S. Mims, Keith W. Pratz, Michael R. Savona, Anthony S. Stein, et al.. 2021. “Ivosidenib or Enasidenib Combined with Intensive Chemotherapy in Patients with Newly Diagnosed AML: A Phase 1 Study”. Blood. American Society of Hematology. doi:10.1182/blood.2020007233.

Current Opinion in HematologyJournal

Maintenance Therapy for Acute Myeloid Leukemia: Sustaining the Pursuit for Sustained Remission

Shallis, Rory M., and Nikolai A. Podoltsev. 2020. “Maintenance Therapy for Acute Myeloid Leukemia: Sustaining the Pursuit for Sustained Remission”. Current Opinion in Hematology. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/moh.0000000000000637.

idh1/2Journal

Pharmacokinetic/pharmacodynamic Evaluation of Ivosidenib or Enasidenib Combined with Intensive Induction and Consolidation Chemotherapy in Patients with Newly Diagnosed <i>idh1/2</i> ‐mutant Acute Myeloid Leukemia

Fan, Bin, Yue Chen, Feng Yin, Lei Hua, Caroline Almon, Salah Nabhan, Michael Cooper, Hua Yang, and Mohammad Hossain. 2022. “Pharmacokinetic/pharmacodynamic Evaluation of Ivosidenib or Enasidenib Combined with Intensive Induction and Consolidation Chemotherapy in Patients with Newly Diagnosed idh1/2 ‐mutant Acute Myeloid Leukemia”. Clinical Pharmacology in Drug Development. Wiley. doi:10.1002/cpdd.1067.

clinicaltrials.govStudy