At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 145 enrolled
Drug / intervention
Ibrutinibdrug
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.
An Open-label, Single Arm, Multicenter Phase 2 Study of the Bruton's Tyrosine Kinase Inhibitor PCI-32765 (Ibrutinib) in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma With 17p Deletion (RESONATE™-17)
In Brief
A Phase 2 clinical trial evaluating Ibrutinib for Chronic Lymphocytic Leukemia With 17p Deletion and Small Lymphocytic Lymphoma With 17p Deletion. Completed, enrolled 145 participants across 55 sites in 9 countries.
Detailed Summary
An Open-label, Single arm, Multicenter Phase 2 Study of the Bruton's Tyrosine Kinase Inhibitor ibrutinib in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma with 17p Deletion
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Lymphocytic Leukemia With 17p Deletion, Small Lymphocytic Lymphoma With 17p Deletion
CountriesAustralia, Belgium, Canada, Germany, New Zealand, Sweden, Turkey (Türkiye), United Kingdom, United States
CollaboratorsJanssen Research & Development, LLC
Timeline
Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedDec 2012
Enrollment StartJan 2013
Primary CompletionJun 2014
Study CompletionApr 2016
TodayJul 2026
First PostedDec 7, 2012
Enrollment StartJan 1, 2013
Primary CompletionJun 1, 2014
Study CompletionApr 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 13.6 years ago
Interventions
Ibrutinibdrug
All subjects will receive ibrutinib 420 mg (3 x 140-mg capsules) orally once daily.