NCT02677922

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 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

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 130 (actual)
• Sponsor: Celgene · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Leukemia, Myeloid, Acute

Interventions

Type	Name	Description
DRUG	AG-120	Specified dose on specified days
DRUG	Azacitidine	Specified dose on specified days
DRUG	AG-221	Specified dose on specified days

Timeline

• Start date: 2016-06-03
• Primary completion: 2018-08-02
• Completion: 2026-09-30
• First posted: 2016-02-09
• Last updated: 2026-02-19
• Results posted: 2022-11-22

Locations

49 sites across 14 countries: United States, Australia, Belgium, Canada, France, Germany, Italy, Netherlands, Portugal, South Korea, Spain, Sweden, Switzerland, United Kingdom