# 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

Source: https://onco.cc/trials/nct02677922/  
OnCo record `nct02677922` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 1/2 trial of Azacitidine in acute myeloid leukaemia, run by Celgene, active and no longer recruiting.

## Summary

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 is a phase 1/2 interventional study registered as NCT02677922 by Celgene, with 130 participants enrolled, started 2016-06-03 and due to reach its primary completion in 2018-08-02. Interventions recorded: AG-120, Azacitidine and AG-221. Results have been posted on the registry.

## Fields

- Kind: Trial
- Status: active
- Last checked: 2026-09-22
- Tags: pipeline; ctgov-ingest
- Registry id: NCT02677922
- Phase: 1/2
- Setting: A Phase 1b/2 Open-Label, Randomized Study of 2 Combinations of Isocitrate Dehydrogenase (IDH) Mutant Targeted Therapies Plus Azacitidine: Oral AG-120 Plus Subcutaneous Azacitidine and Oral AG-221 Plus SC Azacitidine in Subjects With Newly Diagnosed Acute Myeloid Leukemia Harboring an IDH1 or an IDH2 Mutation, Respectively, Who Are Not Candidates to Receive Intensive Induction Chemotherapy
- Sponsor: Celgene
- Enrolled: 130
- Outcomes: Overall Response Rate: Phase 2 (Randomized Stage): Phase 2 Randomized Stage: AG-221 (100mg) + AZA 73.5% vs Phase 2 Randomized Stage: AZA Monotherapy 36.4%; Overall Survival: Phase 2 (Randomized Stage): Phase 2 Randomized Stage: AG-221 (100mg) + AZA 22 months vs Phase 2 Randomized Stage: AZA Monotherapy 22.3 months

## Sources

- ClinicalTrials.gov NCT02677922: https://clinicaltrials.gov/study/NCT02677922

## Connected records

- cancers: [Acute myeloid leukaemia](https://onco.cc/cancers/aml/), [IDH1- and IDH2-mutated acute myeloid leukaemia](https://onco.cc/cancers/aml-idh/)
- technologies: [Cytotoxic chemotherapy](https://onco.cc/technologies/cytotoxic-chemotherapy/), [Epigenetic drugs (HDAC, DNMT, EZH2, IDH, menin, BET)](https://onco.cc/technologies/epigenetic-drugs/)
- drugs: [Azacitidine](https://onco.cc/drugs/azacitidine/)
- companies: [Bristol Myers Squibb](https://onco.cc/companies/bms/)

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