CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 323 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/NCT02910583
NCT02910583Phase 2Completed
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Phase 2 Study of the Combination of Ibrutinib Plus Venetoclax in Subjects With Treatment-naïve Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Pharmacyclics LLC.·interventional·Posted Sep 22, 2016·Updated Dec 20, 2024

In Brief

A Phase 2 clinical trial evaluating ibrutinib, venetoclax, and 1 other intervention for Leukemia and 2 related conditions. Completed, enrolled 323 participants across 46 sites in 6 countries.

Detailed Summary

This is a multicenter, 2-cohort Phase 2 study assessing both minimal residual disease (MRD)-guided discontinuation and fixed duration therapy with the combination of ibrutinib + venetoclax in subjects with treatment-naïve CLL or SLL.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLeukemia, Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
CountriesAustralia, Italy, New Zealand, Poland, Spain, United States
CollaboratorsJanssen Research & Development, LLC

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedSep 22, 2016
Enrollment StartSep 28, 2016
Primary CompletionNov 12, 2020
Study CompletionMar 27, 2024
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 9.8 years ago

Interventions

ibrutinibdrug

ibrutinib administered orally once daily (three 140 mg capsules)

venetoclaxdrug

venetoclax tablets will be administered orally once daily starting with a 5 week ramp up of 20 mg, 50 mg, 100 mg, 200 mg and 400 mg. After ramp up, venetoclax will be administered at 400 mg.

Placebodrug

placebo capsules to match ibrutinib administered orally once daily