CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 20 enrolled
Drug / intervention
Obinutuzumab +1 moredrug
Likely dose
Not stated in 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/NCT01868893
NCT01868893Phase 2Completed

An Expanded Access, Open-Label Study of Obinutuzumab (GA101) Plus Chlorambucil in Patients With Previously Untreated Chronic Lymphocytic Leukemia

Genentech, Inc.·interventional·Posted Jun 5, 2013·Updated Apr 17, 2017

In Brief

A Phase 2 clinical trial evaluating Obinutuzumab and Chlorambucil for Chronic Lymphocytic Leukemia. Completed, enrolled 20 participants across 19 sites.

Detailed Summary

This is a multicenter, open-label, single-arm, expanded access treatment study designed to provide obinutuzumab to patients with previously untreated Chronic Lymphocytic Leukemia (CLL) in combination with chlorambucil and to evaluate the safety and efficacy of obinutuzumab administered in combination with chlorambucil. This study will enroll patients with previously untreated CD20-positive CLL requiring treatment according to the IWCLL guidelines (Hallek et al 2008), as assessed by the investigator.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJun 5, 2013
Enrollment StartAug 1, 2013
Primary CompletionJan 1, 2014
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 13.1 years ago

Interventions

Obinutuzumabdrug

Chlorambucildrug