CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 269 enrolled
Drug / intervention
Ibrutinib +1 moredrug
Likely dose
Ibrutinib 420 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/NCT01724346
NCT01724346Phase 3Completed
CompareCT.gov

An Open-label Extension Study in Patients 65 Years or Older With Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) Who Participated in Study PCYC-1115-CA (Ibrutinib Versus Chlorambucil)

Pharmacyclics LLC.·interventional·Posted Nov 9, 2012·Updated Sep 19, 2024

In Brief

A Phase 3 clinical trial evaluating Ibrutinib and Next-line ibrutinib for Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma. Completed, enrolled 269 participants across 88 sites in 16 countries.

Detailed Summary

An Open-label Extension Study in Patients 65 Years or Older with Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) Who Participated in Study PCYC-1115-CA (Ibrutinib versus Chlorambucil)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
CountriesAustralia, Belgium, Canada, China, Czechia, Ireland, Israel, Italy, New Zealand, Poland, Russia, Spain, Turkey (Türkiye), Ukraine, United Kingdom, United States
CollaboratorsJanssen Research & Development, LLC

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedNov 9, 2012
Enrollment StartDec 3, 2013
Primary CompletionAug 18, 2023
TodayJul 2, 2026
Enrollment to primary: 9.7 yearsPosted 13.6 years ago

Interventions

Ibrutinibdrug

Ibrutinib 420 mg (3 x 140-mg capsules) is administered orally once daily

Next-line ibrutinibdrug

Ibrutinib 420 mg (3 x 140-mg capsules) is administered orally once daily