Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
completion around

Description

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.

Official Title

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

Keywords

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, Acute Myeloid Leukemia, AML, De novo AML, Secondary AML, Newly diagnosed AML, IDH1, IDH2, Induction therapy, Consolidation therapy, IDH, Leukemia, Myeloid Leukemia, Leukemia, Myeloid, Acute, Preleukemia, Myelodysplastic Syndromes, Hematologic Diseases, Cytarabine, Etoposide, Daunorubicin, Mitoxantrone, Idarubicin

Eligibility

Locations

  • UCLA Medical Center
    Los Angeles California 90024 United States
  • City of Hope
    Duarte California 91010 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Institut de Recherches Internationales Servier
ID
NCT02632708
Phase
Phase 1 research study
Study Type
Interventional
Participants
About 153 people participating
Last Updated