NCT03941964

A Study of the Effectiveness of Venetoclax in Combination With Azacitidine or Decitabine in an Outpatient Setting in Patients With Acute Myeloid Leukemia (AML) Ineligible for Intensive Chemotherapy

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: AbbVie · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Myeloid Leukemia (AML)
• Cancer

Interventions

Type	Name	Description
DRUG	Venetoclax	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.
DRUG	Azacitidine	The azacitidine infusion was prepared and administered per the package insert and given either subcutaneously or intravenously, per institutional practice.
DRUG	Decitabine	The decitabine infusion was prepared and administered per the package insert and given intravenously, per institutional practice.

Timeline

• Start date: 2019-08-15
• Primary completion: 2022-03-14
• Completion: 2022-03-14
• First posted: 2019-05-08
• Last updated: 2023-03-20
• Results posted: 2023-03-20

Locations

16 sites across 1 country: United States

Regulatory

• FDA-regulated drug study