At a glance
ClinicalIndex Comparison Record- ✓Confirmed diagnosis of CLL/SLL requiring therapy per iwCLL 2018 criteria
- ✓Part 1: Known 17p deletion status (wildtype or deleted); Part 2: Must have deletion of 17p by FISH
- ✓ECOG Performance Status 0-2
- ✓Adequate organ function: platelets, hemoglobin, neutrophils, kidney function per specified thresholds
- ✕Richter's transformation to DLBCL, prolymphocytic leukemia, or Hodgkin's lymphoma
- ✕CNS involvement
- ✕Significant history of renal, neurologic, psychiatric, endocrine, metabolic or immunologic disease
- ✕Active uncontrolled auto-immune cytopenia (e.g., AIHA, ITP)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3 Open-Label, Randomized Study of Pirtobrutinib (LOXO-305) Versus Ibrutinib in Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (BRUIN-CLL-314)
In Brief
A Phase 3 clinical trial evaluating Pirtobrutinib and Ibrutinib for Chronic Lymphocytic Leukemia and 3 related conditions. Currently recruiting, targeting 737 participants across 143 sites in 23 countries.
Signals
Detailed Summary
The purpose of Part 1 of this study is to compare the efficacy and safety of pirtobruitinib (LOXO-305) to ibrutinib in participants with CLL/SLL; participants may or may not have already had treatment for their cancer. The purpose of Part 2 of this study evaluates pirtobrutinib monotherapy in treatment-naïve participants with CLL/SLL with 17p deletions. Participation could last up to six years for Part 1. Participation could last up to 2 years for Part 2.
Study Details
Timeline
Interventions
Administered orally.
Administered orally.