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NCT02632708 · ClinicalTrials.gov registry record · Phase 1
Safety Study of AG-120 or AG-221 in Combination With Induction and Consolidation Therapy in Participants With Newly Diagnosed Acute Myeloid Leukemia (AML) With an IDH1 and/or IDH2 Mutation
A Phase 1 study of Untreated AML and Newly Diagnosed Acute Myeloid Leukemia (AML), sponsored by Institut de Recherches Internationales Servier.
- Active
- Registry status
- Phase 1
- Development phase
- 153
- Enrollment target
- 17
- Study locations
NCT02632708: Active Phase 1 study of Untreated AML and Newly Diagnosed Acute Myeloid Leukemia (AML), sponsored by Institut de Recherches Internationales Servier.
NCT02632708 is a Phase 1 study of Untreated AML and Newly Diagnosed Acute Myeloid Leukemia (AML) that is active but no longer recruiting, run by Institut de Recherches Internationales Servier. The registered enrollment target is 153 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (155% higher). The trial reports 17 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02632708, a Phase 1 study of Untreated AML and Newly Diagnosed Acute Myeloid Leukemia (AML), is active but no longer recruiting, sponsored by Institut de Recherches Internationales Servier.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 153 participants
- Enrollment target
- 17
- Study locations
Study Summary
The purpose of this Phase I, multicenter, clinical trial is to evaluate the safety of AG-120 and AG-221 when given in combination with standard AML induction and consolidation therapy. The study plans to evaluate up to 2 dose levels of AG-120 in participants with an isocitrate dehydrogenase protein 1 (IDH1) mutation and up to 2 dose levels of AG-221 in participants with an isocitrate dehydrogenase protein 2 (IDH2) mutation. AG-120 or AG-221 will be administered with 2 types of AML induction therapies (cytarabine with either daunorubicin or idarubicin) and 2 types of AML consolidation therapies (mitoxantrone with etoposide \[ME\] or cytarabine). After consolidation therapy, participants may continue on to maintenance therapy and receive daily treatment with single-agent AG-120 or AG-221 until relapse, development of an unacceptable toxicity, or hematopoietic stem cell transplant (HSCT). The study will end when all participants have discontinued study treatment.
Primary Outcome
An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related.
Conditions Studied
Interventions
- DRUG AG-120
- DRUG AG-221
- DRUG cytarabine
- DRUG daunorubicin
- DRUG idarubicin
Study Locations (17)
Other
- Universitatsklinikum Ulm - Ulm
- VU Medisch Centrum - Amsterdam
- Erasmus MC - Rotterdam
California
- City of Hope - Duarte
- UCLA Medical Center - Los Angeles
Massachusetts
- Dana Farber Cancer Institute - Boston
- Massachusetts General Hospital - Boston
Texas
- University of Texas Southwestern Medical Center - Dallas
- MD Anderson Cancer Center - Houston
Colorado
- University of Colorado - Aurora
Illinois
- University of Chicago - Chicago
Maryland
- Johns Hopkins University - Baltimore
New Jersey
- Hackensack University Medical Center - Hackensack
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 153 participants |
| Start Date | 2015-12-31 |
| Est. Completion | 2026-07-24 |
| Phase | Phase 1 |
What the registry record for NCT02632708 still lists
NCT02632708 is an interventional study that assigns participants to a tested intervention. The registered 153 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (155% higher).
The record links to 5 conditions, with Untreated AML appearing as the primary indexed condition, and to 5 interventions - of which AG-120 is the first listed.
NCT02632708 lists 17 locations in 12 states (Other, California, Massachusetts).
Frequently Asked Questions
What is clinical trial NCT02632708 about?
NCT02632708 is a clinical study titled "Safety Study of AG-120 or AG-221 in Combination With Induction and Consolidation Therapy in Participants With Newly Diagnosed Acute Myeloid Leukemia (AML) With an IDH1 and/or IDH2 Mutation". The purpose of this Phase I, multicenter, clinical trial is to evaluate the safety of AG-120 and AG-221 when given in combination with standard AML induction and consolidation therapy. The study plans to evaluate up to 2 dose levels of AG-120 in participants with an isocitrate dehydrogenase protein ...
What is the current status of trial NCT02632708?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 153 participants. The study started on 2015-12-31. Estimated completion is 2026-07-24.
What conditions does trial NCT02632708 study?
This clinical trial studies the following conditions: Untreated AML, Newly Diagnosed Acute Myeloid Leukemia (AML), AML Arising From Myelodysplastic Syndrome (MDS), AML Arising From Antecedent Hematologic Disorder (AHD), AML Arising After Exposure to Genotoxic Injury.
What interventions are being tested in trial NCT02632708?
The interventions under investigation include: AG-120 (DRUG), AG-221 (DRUG), cytarabine (DRUG), daunorubicin (DRUG), idarubicin (DRUG).
Who is sponsoring clinical trial NCT02632708?
This trial is sponsored by Institut de Recherches Internationales Servier, which has 27 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02632708 being conducted?
This trial has 17 study locations across California, Colorado, Illinois, Maryland, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02632708's enrollment target sits among peer trials
153 358th of 2000 higher than 1,642 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
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