CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 249 target
Drug / intervention
Pirtobrutinibdrug
Likely dose
Not stated in record
Key inclusion· 8
  • Confirmed diagnosis of CLL/SLL per iwCLL 2018 criteria
  • Part 1: Prior CLL/SLL treatment (1-3 lines)
  • Part 1: Prior covalent BTK inhibitor
  • Part 2: No prior CLL/SLL treatment
Key exclusion· 5
  • Prior BTK degrader or noncovalent BTK inhibitor
  • History of Grade ≥3 bleeding due to BTK inhibitor treatment
  • Known or suspected Richter's transformation
  • Known or suspected CNS involvement by CLL/SLL

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06588478
NCT06588478Phase 2RecruitingHigh Momentum

A Phase 2, Open-Label, Randomized Study Evaluating the Efficacy and Safety of 3 Doses of Pirtobrutinib in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Who Previously Received Treatment With a Covalent Bruton Tyrosine Kinase Inhibitor

Loxo Oncology, Inc.·interventional·Posted Sep 19, 2024·Updated May 19, 2026

In Brief

A Phase 2 clinical trial evaluating Pirtobrutinib for Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma. Currently recruiting, targeting 249 participants across 131 sites in 18 countries.

Signals

Enrolling ahead of pace

Detailed Summary

The main purpose of Part 1 of this study is to assess the efficacy and safety of 3 dose levels of Pirtobrutinib in participants with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), who have received 1-3 lines of treatment including a covalent Bruton tyrosine kinase (BTK) inhibitor. The purpose of Part 2 of this study is to evaluate pirtobrutinib monotherapy in participants with treatment-naïve CLL/SLL with 17p deletions. Participation in Part 1 is expected to last approximately 3 years. Participation in Part 2 is expected to last up to 2 years.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, Belgium, Canada, Czechia, Denmark, France, Germany, Greece, Hungary, Italy, Poland, Romania, Slovakia, South Korea, Spain, Turkey (Türkiye), United Kingdom, United States

Timeline

Phase 2Recruiting
20252026202720282029
First PostedSep 19, 2024
Enrollment StartJan 3, 2025
Primary CompletionJun 1, 2028
Study CompletionDec 1, 2028
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 1.8 years agoPrimary completion in 1.9 years

Interventions

Pirtobrutinibdrug

Administered Orally.