At a glance
ClinicalIndex Comparison RecordPhase 3Active· 309 enrolled
Drug / intervention
Pirtobrutinib +2 moredrug
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.
A Phase 3 Open-Label, Randomized Study of Pirtobrutinib (LOXO-305) Versus Bendamustine Plus Rituximab in Untreated Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
In Brief
A Phase 3 clinical trial evaluating Pirtobrutinib, Bendamustine, and 1 other intervention for Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma. Active but no longer recruiting, targeting 309 participants across 108 sites in 20 countries.
Detailed Summary
The purpose of this study is to compare the efficacy and safety of pirtobrutinib (LOXO-305; Arm A) compared to BR (Arm B) in patients with CLL/SLL who have not been treated. Participation could last up to five years.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, Austria, Brazil, Bulgaria, China, Czechia, France, Hungary, Italy, Japan, New Zealand, Poland, Portugal, Romania, Russia, South Korea, Spain, Taiwan, United Kingdom, United States
CollaboratorsEli Lilly and Company
Timeline
Phase 3Active
202220232024202520262027
First PostedAug 2021
Enrollment StartSep 2021
Primary CompletionJul 2025
TodayJul 2026
Study CompletionOct 2027
First PostedAug 27, 2021
Enrollment StartSep 23, 2021
Primary CompletionJul 11, 2025
Study CompletionOct 1, 2027
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 4.8 years ago
Interventions
Pirtobrutinibdrug
Oral
Bendamustinedrug
IV
Rituximabdrug
IV