CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 72 enrolled
Drug / intervention
bendamustine +1 moredrug
Likely dose
bendamustine 70 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/NCT02071225
NCT02071225Phase 2Completed
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Phase II Trial to Evaluate The Efficacy of Obinutuzumab (RO5072759) + Bendamustine Treatment in Patients With Refractory Or Relapsed Chronic Lymphocytic Leukemia

Hoffmann-La Roche·interventional·Posted Feb 25, 2014·Updated Feb 7, 2020

In Brief

A Phase 2 clinical trial evaluating bendamustine and obinutuzumab for Chronic Lymphocytic Leukemia. Completed, enrolled 72 participants across 21 sites.

Detailed Summary

This phase II trial was designed to evaluate the efficacy of obinutuzumab and bendamustine treatment in participants with refractory or relapsed chronic lymphocytic leukemia (CLL). Participants receive up to six 28-day cycles of treatment. Treatment consists of intravenous (IV) administration of obinutuzumab and bendamustine. Treatment time is expected to last 6 months, and participant follow-up will last 2 years.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Lymphocytic Leukemia
CountriesSpain
Collaborators--

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedFeb 25, 2014
Enrollment StartApr 9, 2014
Primary CompletionNov 19, 2018
TodayJul 2, 2026
Enrollment to primary: 4.6 yearsPosted 12.4 years ago

Interventions

bendamustinedrug

70 milligrams per square meter (mg/m\^2) given by intravenous (IV) infusion on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of subsequent cycles.

obinutuzumabdrug

1000 mg given by IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of subsequent cycles.