CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 578 enrolled
Drug / intervention
Ibrutinib +3 moredrug
Likely dose
Bendamustine hydrochloride 70 mg/m2from 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/NCT01611090
NCT01611090Phase 3Completed
CompareCT.gov

Randomized, Double-blind, Placebo-controlled Phase 3 Study of Ibrutinib, a Bruton's Tyrosine Kinase (BTK) Inhibitor, in Combination With Bendamustine and Rituximab (BR) in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Janssen Research & Development, LLC·interventional·Posted Jun 4, 2012·Updated Mar 3, 2020

In Brief

A Phase 3 clinical trial evaluating Ibrutinib, Bendamustine hydrochloride, and 2 other interventions for Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma. Completed, enrolled 578 participants across 155 sites in 21 countries.

Detailed Summary

The purpose of this study is to examine the safety and efficacy of Ibrutinib administered in combination with bendamustine and rituximab in patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
CountriesArgentina, Belgium, Brazil, Canada, Colombia, Czechia, France, Germany, Greece, Israel, Mexico, Poland, Portugal, Russia, South Korea, Spain, Sweden, Turkey (Türkiye), Ukraine, United Kingdom, United States
CollaboratorsPharmacyclics LLC.

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJun 4, 2012
Enrollment StartSep 19, 2012
Primary CompletionJan 23, 2019
TodayJul 2, 2026
Enrollment to primary: 6.3 yearsPosted 14.1 years ago

Interventions

Ibrutinibdrug

Type=exact number, unit=mg, number=420 , form=capsule, route=oral use. Capsule is taken once daily continuously.

Bendamustine hydrochloridedrug

Type=exact number, unit=mg, number=70 mg/m2, route=intravenous use. Administered intravenously on Cycle 1, Days 2-3 and Cycles 2-6, Days 1-2.

Rituximabdrug

Type=exact number, unit=mg, number=375 mg/m2 and 500 mg/m2, route=intravenous use. Administered intravenously on Cycle 1, Day 1, and Cycles 2-6, Day 1, respectively.

Placebodrug

Form=capsule, route=oral use. Capsule is taken once daily continuously.