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NCT02677922 · ClinicalTrials.gov registry record · Phase 1

A Study to Assess the Safety and Efficacy of Two Combinations of Isocitrate Dehydrogenase (IDH) Mutant Targeted Therapies Plus Azacitidine in Participants With Newly Diagnosed Acute Myeloid Leukemia (AML) Harboring IDH Mutations Who Are Not Candidates to Receive Intensive Induction Chemotherapy

A Phase 1 study of Leukemia, Myeloid, Acute, sponsored by Celgene.

Active
Registry status
Phase 1
Development phase
130
Enrollment target
20
Study locations

NCT02677922: Active Phase 1 study of Leukemia, Myeloid, Acute, sponsored by Celgene.

NCT02677922 is a Phase 1 study of Leukemia, Myeloid, Acute that is active but no longer recruiting, run by Celgene. The registered enrollment target is 130 participants, above the 112-participant average among 30 other Leukemia, Myeloid, Acute trials with a reported enrollment target (16% higher). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02677922, a Phase 1 study of Leukemia, Myeloid, Acute, is active but no longer recruiting, sponsored by Celgene.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
130 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study are 1. to determine the recommended combination dose of AG-120 and AG-221 separately when administered with azacitidine and, 2. to investigate the safety, tolerability, and efficacy of the combinations of AG-120 with azacitidine and AG-221 with azacitidine versus with azacitidine alone in participants with acute myeloid leukemia (AML) with the isocitrate dehydrogenase (IDH) enzyme isoforms 1 or 2 mutations, respectively.

Primary Outcome

Dose-limiting toxicities (DLTs) are defined as an event that constitute a change from baseline irrespective of outcome and determined by the investigator to be related to treatment. The DLT-evaluable participants were defined as participants who took at least 1 dose of study drug in the Phase 1b Dose-Finding Stage and either had a DLT during Cycle 1 (regardless of amount of study drug exposure), or had no DLT and completed at least 75% of AG-120 or AG-221 doses (21 out of 28 days) and a minimum

Conditions Studied

Leukemia, Myeloid, Acute

Interventions

  • DRUG Azacitidine
  • DRUG AG-120
  • DRUG AG-221

Study Locations (20)

Other

  • Local Institution - 175 - Melbourne
  • Local Institution - 177 - Perth
  • Local Institution - UNK-121 - Yvoir
  • Local Institution - 205 - Lille
  • Local Institution - 206 - Marseille
  • Local Institution - 200 - Paris
  • Local Institution - 204 - Pessac
  • Local Institution - 202 - Pierre-Bénite
  • Local Institution - 203 - Toulouse

Massachusetts

  • Local Institution - 102 - Boston
  • Beth Israel Deaconess Medical Center - Boston
  • Local Institution - 902 - Boston

Illinois

  • Local Institution - 108 - Chicago
  • Local Institution - 103 - Chicago

California

  • Local Institution - 105 - Duarte

Connecticut

  • Local Institution - 107 - New Haven

New York

  • Local Institution - 106 - New York

Texas

  • Local Institution - 110 - Dallas

South Australia

  • Local Institution - 178 - Adelaide

Trial Details

FieldValue
Enrollment Target 130 participants
Start Date 2016-06-03
Est. Completion 2026-09-30
Phase Phase 1
Celgene

308 total trials

What the registry record for NCT02677922 still lists

NCT02677922 is an interventional study that assigns participants to a tested intervention. The registered 130 participants enrollment target is mid-sized for trials with a published cap, above the 112-participant average among 30 other Leukemia, Myeloid, Acute trials with a reported enrollment target (16% higher).

The record links to 1 condition, with Leukemia, Myeloid, Acute appearing as the primary indexed condition, and to 3 interventions - of which Azacitidine is the first listed.

NCT02677922 names 20 study sites across 9 states, led by Other, Massachusetts, Illinois.

Frequently Asked Questions

What is clinical trial NCT02677922 about?

NCT02677922 is a clinical study titled "A Study to Assess the Safety and Efficacy of Two Combinations of Isocitrate Dehydrogenase (IDH) Mutant Targeted Therapies Plus Azacitidine in Participants With Newly Diagnosed Acute Myeloid Leukemia (AML) Harboring IDH Mutations Who Are Not Candidates to Receive Intensive Induction Chemotherapy". The purpose of this study are 1. to determine the recommended combination dose of AG-120 and AG-221 separately when administered with azacitidine and, 2. to investigate the safety, tolerability, and efficacy of the combinations of AG-120 with azacitidine and AG-221 with azacitidine versus with azac...

What is the current status of trial NCT02677922?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 130 participants. The study started on 2016-06-03. Estimated completion is 2026-09-30.

What conditions does trial NCT02677922 study?

This clinical trial studies the following conditions: Leukemia, Myeloid, Acute.

What interventions are being tested in trial NCT02677922?

The interventions under investigation include: Azacitidine (DRUG), AG-120 (DRUG), AG-221 (DRUG).

Who is sponsoring clinical trial NCT02677922?

This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02677922 being conducted?

This trial has 20 study locations across California, Connecticut, Illinois, Massachusetts, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Leukemia, Myeloid, Acute

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT02677922's enrollment target sits among peer trials

130 10th of 30 higher than 21 of 30 other Leukemia, Myeloid, Acute trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Leukemia, Myeloid, Acute 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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Related registry views

Source: ClinicalTrials.gov NCT02677922, the US trial registry maintained by the National Library of Medicine. NCT02677922 (mid enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.