NCT02980731

A Study Evaluating the Impact of Venetoclax on the Quality of Life for Subjects With Relapsed (Your Cancer Has Come Back) or Refractory (no Response to Previous Cancer Treatments) Chronic Lymphocytic Leukemia (CLL) While Receiving Venetoclax Monotherapy (a Single Agent).

Open-Label, Single Arm, Phase 3b, Multi-Center Study Evaluating the Impact of Venetoclax on the Quality of Life of Relapsed/Refractory Subjects With Chronic Lymphocytic Leukemia (CLL) (VENICE II)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 210 (actual)
• Sponsor: AbbVie · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this open-label, single-arm study was to evaluate the impact of venetoclax on the quality of life of participants including those with with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL; a type of cancer affecting the blood and the bone marrow) with or without the 17p deletion or TP53 mutation, including participants with an unknown status, as well as R/R CLL participants who had been previously treated with B-cell receptor inhibitor (BCRi) therapy. The starting dose of venetoclax was 20 mg once daily. The dose must have been gradually increased over a period of 5 weeks up to the daily dose of 400 mg. Participants may have continued receiving venetoclax for up to 2 years. After the treatment period, participants may have continued on into a 2-year follow-up period.

Conditions

• Chronic Lymphocytic Leukemia (CLL)

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.

Timeline

• Start date: 2016-12-13
• Primary completion: 2021-12-29
• Completion: 2021-12-29
• First posted: 2016-12-02
• Last updated: 2023-02-22
• Results posted: 2023-02-22

Locations

33 sites across 10 countries: Argentina, Australia, Bulgaria, Hong Kong, Hungary, Mexico, New Zealand, Poland, Russia, Taiwan

Regulatory

• FDA-regulated drug study