CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 389 enrolled
Drug / intervention
Bendamustine +2 moredrug
Likely dose
Bendamustine 70 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02005471
NCT02005471Phase 3Completed
CompareCT.gov

A Multicenter, Phase III, Open-Label, Randomized Study in Relapsed/Refractory Patients With Chronic Lymphocytic Leukemia to Evaluate the Benefit of Venetoclax (GDC-0199/ABT-199) Plus Rituximab Compared With Bendamustine Plus Rituximab

Hoffmann-La Roche·interventional·Posted Dec 9, 2013·Updated Oct 17, 2023

In Brief

A Phase 3 clinical trial evaluating Bendamustine, Venetoclax, and 1 other intervention for Chronic Lymphocytic Leukemia. Completed, enrolled 389 participants across 111 sites in 20 countries.

Detailed Summary

The purpose of this open-label, multicenter, randomized, Phase III study is to evaluate the benefit of venetoclax in combination with rituximab compared with bendamustine in combination with rituximab in participants with relapsed or refractory CLL. Participants will be randomly assigned in 1:1 ratio to receive either venetoclax + rituximab (Arm A) or bendamustine + rituximab (Arm B).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Lymphocytic Leukemia
CountriesAustralia, Austria, Belgium, Canada, Czechia, Denmark, France, Germany, Hungary, Italy, Netherlands, New Zealand, Poland, Russia, South Korea, Spain, Sweden, Taiwan, United Kingdom, United States
CollaboratorsAbbVie

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedDec 9, 2013
Enrollment StartMar 17, 2014
Primary CompletionMay 8, 2017
Study CompletionAug 3, 2022
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 12.6 years ago

Interventions

Bendamustinedrug

Bendamustine will be administered at a dose of 70 mg/m\^2 via IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.

Venetoclaxdrug

Venetoclax will be administered at an initial dose of 20 mg via tablet orally QD, incremented weekly up to a maximum dose of 400 mg during a 5-week ramp-up period. Venetoclax will be continued at 400 mg QD from Week 6 (Day 1 of Cycle 1 of combination therapy) onwards up to disease progression (PD) or 2 years, whichever occurs first. R/C Substudy: venetoclax will be administered for 5-week dose ramp-up period to reach the target dose of 400 mg QD. Venetoclax will continue to be administered during the rituximab cycles until disease progression or for a maximum of 2 years from Cycle 1R/C Day 1 of the R/C Substudy.

Rituximabdrug

Rituximab will be administered at a dose of 375 mg/m\^2 via IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m\^2 on Day 1 of Cycles 2-6. R/C Substudy: Following the venetoclax ramp-up period, rituximab will be administered for 6 cycles consisting of a single infusion on the first day of each 28-day cycle.