At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 127 enrolled
Drug / intervention
Venetoclaxdrug
Likely dose
Venetoclax 240 mLfrom 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.
A Phase 2 Open-Label Study of the Efficacy and Safety of ABT-199 (GDC-0199) in Chronic Lymphocytic Leukemia Subjects With Relapse or Refractory to B-Cell Receptor Signaling Pathway Inhibitor Therapy
In Brief
A Phase 2 clinical trial evaluating Venetoclax for Chronic Lymphocytic Leukemia. Completed, enrolled 127 participants across 15 sites.
Detailed Summary
This was an open-label, non-randomized, multicenter, Phase 2 study evaluating the efficacy and safety of ABT-199 in 127 participants with relapsed or refractory chronic lymphocytic leukemia (CLL) after B-cell receptor signaling pathway inhibitors (BCR PI) treatment.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Lymphocytic Leukemia
CountriesUnited States
CollaboratorsRoche-Genentech
Timeline
Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedMay 2014
Enrollment StartSep 2014
Primary CompletionDec 2021
TodayJul 2026
First PostedMay 19, 2014
Enrollment StartSep 10, 2014
Primary CompletionDec 22, 2021
TodayJul 2, 2026
Enrollment to primary: 7.3 yearsPosted 12.1 years ago
Interventions
Venetoclaxdrug
Each dose of venetoclax was to be taken with approximately 240 mL of water within 30 minutes after the completion of breakfast or the participant's first meal of the day.