At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3, Multicenter, Open-label, Randomized Study Comparing the Efficacy and Safety of AG-221 (CC-90007) Versus Conventional Care Regimens in Older Subjects With Late Stage Acute Myeloid Leukemia Harboring an Isocitrate Dehydrogenase 2 Mutation
In Brief
A Phase 3 clinical trial evaluating AG-221, BSC, and 3 other interventions for Leukemia, Myeloid and Isocitrate Dehydrogenase. Completed, enrolled 319 participants across 93 sites in 18 countries.
Detailed Summary
This is an international, multicenter, open-label, randomized, Phase 3 study comparing the efficacy and safety of AG-221 versus conventional care regimens (CCRs) in subjects 60 years or older with acute myeloid leukemia (AML) refractory to or relapsed after second- or third-line AML therapy and positive for an isocitrate dehydrogenase (IDH2) mutation.
Study Details
Timeline
Interventions
Continuous 28-day cycles of AG 221 100 mg orally (PO) once a day (QD) for 28 days
Best supportive care includes, hydroxyurea for leukocytosis and/or differentiation-like syndrome, anti-infectives, analgesics, antiemetics, antipyretics, transfusions and nutritional support
continuous 28-day cycles of azacitidine 75 mg/m2/day SC for 7 days, plus BSC
continuous 28-day cycles of cytarabine 20 mg SC twice a day (BID) for 10 days, plus BSC
28-day cycles of cytarabine 0.5 to 1.5 g/m2/day IV for 3 to 6 days, per standard institutional practice, plus BSC; only BSC given after IDAC therapy concludes per standard institutional practice