CI

At a glance

ClinicalIndex Comparison Record
Phase 3Active· 238 enrolled
Drug / intervention
Pirtobrutinib +3 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.

Search/NCT04666038
NCT04666038Phase 3Active
CompareCT.gov

A Phase 3 Open-Label, Randomized Study of LOXO-305 Versus Investigator's Choice of Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in BTK Inhibitor Pretreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (BRUIN CLL-321)

Loxo Oncology, Inc.·interventional·Posted Dec 14, 2020·Updated Apr 24, 2026

In Brief

A Phase 3 clinical trial evaluating Pirtobrutinib, Idelalisib, and 2 other interventions for Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma. Active but no longer recruiting, targeting 238 participants across 232 sites in 24 countries.

Detailed Summary

This is a study for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have previously received treatment with at least a BTK inhibitor. The main purpose is to compare LOXO-305 to idelalisib plus rituximab or bendamustine plus rituximab. Participation could last up to four years, and possibly longer, if the disease does not progress.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
CountriesAustralia, Austria, Belgium, Canada, China, Croatia, Czechia, France, Germany, Hungary, Ireland, Israel, Italy, Japan, Poland, Russia, Singapore, South Korea, Spain, Switzerland, Taiwan, Turkey (Türkiye), United Kingdom, United States
CollaboratorsEli Lilly and Company

Timeline

Phase 3Active
2021202220232024202520262027
First PostedDec 14, 2020
Enrollment StartMar 9, 2021
Primary CompletionAug 29, 2023
Study CompletionMay 1, 2027
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 5.5 years ago

Interventions

Pirtobrutinibdrug

Oral Pirtobrutinib

Idelalisibdrug

Oral

Bendamustinedrug

IV

Rituximabdrug

IV