NCT02632708

Safety Study of AG-120 or AG-221 in Combination With Induction and Consolidation Therapy in Participants With Newly Diagnosed Acute Myeloid Leukemia (AML) With an IDH1 and/or IDH2 Mutation

A Phase 1, Multicenter, Open-Label, Safety Study of AG-120 or AG-221 in Combination With Induction Therapy and Consolidation Therapy in Patients With Newly Diagnosed Acute Myeloid Leukemia With an IDH1 and/or IDH2 Mutation

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 153 (actual)
• Sponsor: Institut de Recherches Internationales Servier · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this Phase I, multicenter, clinical trial is to evaluate the safety of AG-120 and AG-221 when given in combination with standard AML induction and consolidation therapy. The study plans to evaluate up to 2 dose levels of AG-120 in participants with an isocitrate dehydrogenase protein 1 (IDH1) mutation and up to 2 dose levels of AG-221 in participants with an isocitrate dehydrogenase protein 2 (IDH2) mutation. AG-120 or AG-221 will be administered with 2 types of AML induction therapies (cytarabine with either daunorubicin or idarubicin) and 2 types of AML consolidation therapies (mitoxantrone with etoposide \[ME\] or cytarabine). After consolidation therapy, participants may continue on to maintenance therapy and receive daily treatment with single-agent AG-120 or AG-221 until relapse, development of an unacceptable toxicity, or hematopoietic stem cell transplant (HSCT). The study will end when all participants have discontinued study treatment.

Conditions

• Newly Diagnosed Acute Myeloid Leukemia (AML)
• Untreated AML
• AML Arising From Myelodysplastic Syndrome (MDS)
• AML Arising From Antecedent Hematologic Disorder (AHD)
• AML Arising After Exposure to Genotoxic Injury

Interventions

Type	Name	Description
DRUG	AG-120
DRUG	AG-221
DRUG	cytarabine
DRUG	daunorubicin
DRUG	idarubicin
DRUG	mitoxantrone
DRUG	etoposide

Timeline

• Start date: 2015-12-31
• Primary completion: 2018-12-13
• Completion: 2026-07-24
• First posted: 2015-12-17
• Last updated: 2025-04-11

Locations

17 sites across 3 countries: United States, Germany, Netherlands