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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 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.

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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.

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

Sponsor

Celgene

308 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02677922

The ClinicalTrials.gov registry entry for NCT02677922 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 130 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 112-participant average among 30 other Leukemia, Myeloid, Acute trials with a reported enrollment target (16% higher). The listed sponsor is Celgene, which has 308 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 9 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.