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ACTIVE NOT RECRUITING 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

NCT02677922 · View on ClinicalTrials.gov ↗

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

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

73 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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 130 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Celgene, which has 73 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02677922 reports 20 study locations spanning 9 distinct geographic areas — top geographies include Other, Massachusetts, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02677922?

The interventions under investigation include: Azacitidine (DRUG), AG-120 (DRUG), AG-221 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02677922?

This trial is sponsored by Celgene, which has 73 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial