At a glance
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A Phase 1/2 Study of Venetoclax in Combination With Low-Dose Cytarabine in Treatment-Naïve Subjects With Acute Myelogenous Leukemia Who Are ≥ 60 Years of Age and Who Are Not Eligible for Standard Anthracycline-Based Induction Therapy
In Brief
A Phase 2 clinical trial evaluating Venetoclax and Cytarabine for Acute Myelogenous Leukemia and AML. Completed, enrolled 94 participants across 9 sites in 4 countries.
Detailed Summary
This study consists of two parts: A Phase 1 dose-escalation part that will evaluate the safety and pharmacokinetic profile of venetoclax in combination with low-dose cytarabine (LDAC), define the maximum tolerated dose (MTD), and generate data to support a recommended Phase 2 dose (RPTD) in treatment-naïve participants with acute myelogenous leukemia (AML); and a Phase 2 part that will evaluate if the RPTD has sufficient efficacy and acceptable toxicity to warrant further development of the combination therapy.
Study Details
Timeline
Interventions
Venetoclax will be taken orally once daily.
Low-dose cytarabine will be administered subcutaneously on Days 1 to 10 of each 28-day cycle.