CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 229 enrolled
Drug / intervention
Ibrutinib +2 moredrug
Likely dose
Ibrutinib 140 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/NCT02264574
NCT02264574Phase 3Completed
CompareCT.gov

A Randomized, Multi-center, Open-label, Phase 3 Study of the Bruton's Tyrosine Kinase Inhibitor Ibrutinib in Combination With Obinutuzumab Versus Chlorambucil in Combination With Obinutuzumab in Subjects With Treatment-naïve Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Pharmacyclics LLC.·interventional·Posted Oct 15, 2014·Updated Sep 21, 2020

In Brief

A Phase 3 clinical trial evaluating Ibrutinib, Obinutuzumab, and 1 other intervention for Chronic Lymphocytic Leukemia and Small-Cell Lymphoma. Completed, enrolled 229 participants across 71 sites in 16 countries.

Detailed Summary

The primary objective of this study is to evaluate the efficacy of ibrutinib in combination with obinutuzumab compared to chlorambucil in combination with obinutuzumab based on the Independent Review Committee (IRC) assessment of progression free survival (PFS). Efficacy will be evaluated according to 2008 International Workshop for Chronic Lymphocytic Leukemia (IWCLL) criteria with the modification for treatment-related lymphocytosis, in subjects with treatment-naive CLL or SLL.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Lymphocytic Leukemia, Small-Cell Lymphoma
CountriesAustralia, Austria, Belgium, Canada, Czechia, France, Israel, Italy, New Zealand, Poland, Russia, Spain, Sweden, Turkey (Türkiye), United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedOct 15, 2014
Enrollment StartOct 6, 2014
Primary CompletionMar 26, 2018
Study CompletionSep 3, 2019
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 11.7 years ago

Interventions

Ibrutinibdrug

Ibrutinib will be supplied as 140 mg hard gelatin capsules for oral (PO) administration.

Obinutuzumabdrug

Obinutuzumab will be supplied as 1000 mg/40 mL solution in a single-use vial for intravenous (IV) administration

Chlorambucildrug

Chlorambucil will be supplied as 2 mg film-coated tablets for oral (PO) administration