At a glance
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A Phase 3b, Single-Arm, Multicenter Open-Label Study of Venetoclax in Combination With Azacitidine or Decitabine in an Outpatient Setting in AML Patients Ineligible for Intensive Chemotherapy
In Brief
A Phase 3 clinical trial evaluating Venetoclax, Azacitidine, and 1 other intervention for Acute Myeloid Leukemia (AML) and Cancer. Completed, enrolled 60 participants across 16 sites.
Detailed Summary
A study evaluating the effectiveness and safety of venetoclax, in combination with azacitidine or decitabine, in an outpatient setting for treatment-naïve participants with AML who are ineligible for intensive chemotherapy.
Study Details
Timeline
Interventions
Venetoclax tablets were to be taken orally once daily with a meal and water in the morning at approximately the same time each day. Tablets were to be swallowed whole and not chewed, crushed, or broken prior to swallowing. On the days that the participant received either azacitidine or decitabine, venetoclax was dosed in clinic and administered prior to these agents.
The azacitidine infusion was prepared and administered per the package insert and given either subcutaneously or intravenously, per institutional practice.
The decitabine infusion was prepared and administered per the package insert and given intravenously, per institutional practice.