NCT02287233

A Study Evaluating Venetoclax in Combination With Low-Dose Cytarabine in Treatment-Naïve Participants With Acute Myelogenous Leukemia

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 94 (actual)
• Sponsor: AbbVie · Industry
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Myelogenous Leukemia
• AML

Interventions

Type	Name	Description
DRUG	Venetoclax	Venetoclax will be taken orally once daily.
DRUG	Cytarabine	Low-dose cytarabine will be administered subcutaneously on Days 1 to 10 of each 28-day cycle.

Timeline

• Start date: 2014-12-31
• Primary completion: 2021-08-10
• Completion: 2021-08-10
• First posted: 2014-11-10
• Last updated: 2022-08-29
• Results posted: 2022-08-29

Locations

9 sites across 4 countries: United States, Australia, Germany, Italy

Regulatory

• FDA-regulated drug study