At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 258 enrolled
Drug / intervention
Venetoclaxdrug
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.
Open-Label, Single Arm, Phase 3b, Multi-Center Study Evaluating the Efficacy of Venetoclax (ABT 199) in Relapsed/Refractory Subjects With Chronic Lymphocytic Leukemia (CLL)
In Brief
A Phase 3 clinical trial evaluating Venetoclax for Chronic Lymphocytic Leukemia. Completed, enrolled 258 participants across 67 sites in 21 countries.
Detailed Summary
The purpose of this study is to evaluate the efficacy of venetoclax monotherapy in participants with relapsed/refractory CLL with or without the 17p deletion or TP53 mutation, including those who have received prior treatment with a B-cell receptor inhibitor.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Lymphocytic Leukemia
CountriesAustria, Belgium, Canada, Denmark, Finland, France, Germany, Greece, Ireland, Israel, Italy, Netherlands, Norway, Portugal, Puerto Rico, Spain, Sweden, Switzerland, Turkey (Türkiye), United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedApr 2016
Enrollment StartJun 2016
Primary CompletionApr 2019
Study CompletionMar 2022
TodayJul 2026
First PostedApr 29, 2016
Enrollment StartJun 22, 2016
Primary CompletionApr 10, 2019
Study CompletionMar 11, 2022
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 10.2 years ago
Interventions
Venetoclaxdrug
Tablets for oral administration