CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 102 enrolled
Drug / intervention
Bendamustine +1 moredrug
Likely dose
Bendamustine 90 milligramsfrom 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/NCT02320487
NCT02320487Phase 2Completed
CompareCT.gov

A Phase II, Open-Label Study of Obinutuzumab Plus Bendamustine (BG) in Patients With Previously Untreated Chronic Lymphocytic Leukemia

Genentech, Inc.·interventional·Posted Dec 19, 2014·Updated Feb 11, 2020

In Brief

A Phase 2 clinical trial evaluating Bendamustine and Obinutuzumab for Chronic Lymphocytic Leukemia. Completed, enrolled 102 participants across 26 sites.

Detailed Summary

This is a Phase 2, open-label, multicenter study to evaluate the safety and efficacy of BG induction therapy in participants with previously untreated CLL. The anticipated time on study treatment is 24 weeks.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Lymphocytic Leukemia
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedDec 19, 2014
Enrollment StartMar 31, 2015
Primary CompletionNov 7, 2016
Study CompletionFeb 6, 2019
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 11.5 years ago

Interventions

Bendamustinedrug

Bendamustine was administered as an intravenous infusion at a dose of 90 milligrams per square meter (mg/m\^2) on Days 2 and 3 Cycle 1; and on Days 1 and 2 Cycles 2-6.

Obinutuzumabdrug

Obinutuzumab was administered as an intravenous infusion at a dose of 100 milligrams (mg) on Day 1 Cycle 1; at a dose of 900 mg on Day 2 Cycle 1; at a dose of 1000 mg on Days 8 and 15 Cycle 1, and Day 1 Cycles 2-6.