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Clinical Trial Details

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Brief Title A Safety and Efficacy Study of Oral AG-120 Plus Subcutaneous Azacitidine and Oral A-221 Plus Subcutaneous Azacitidine in Subjects With Newly Diagnosed Acute Myeloid Leukemia (AML)
Official Title 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
Principal Investigator Odenike, Olatoyosi
Brief Summary This Phase 1b/2 study is an open-label, randomized, multicenter trial to evaluate the safety and efficacy of oral AG-120 + SC azacitidine and oral A-221 + Subcutaneous (SC) azacitidine in subjects with newly diagnosed Acute myeloid leukemia (AML) harboring an Isocitrate dehydrogenase 1 (IDH1) or an Isocitrate dehydrogenase 2 (IDH2) mutation, respectively. The study population consists of subjects who are not candidates to receive intensive IC. The study comprises a Phase 1b dose-escalation stage and a Phase 2 randomized stage.
Gender Both
Ages 18 Years
Enrollment 272
Accepts Healthy Volunteers No
Lead Sponsor Celgene CorporationIndustry
Collaborator
Study Design Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Study Phase Phase 1/Phase 2
Study Type Interventional
Contact Name
Contact Phone 1-855-702-8222 (adult trials) or 1-773-702-6808 (pediatric trials)
Condition Leukemia, Myeloid, Acute
Detail for Health Professional (on clinicaltrials.gov)
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