J2N-MC-JZNX
Research type
Research Study
Full title
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
IRAS ID
1010491
Contact name
Emily Coss
Contact email
Sponsor organisation
Eli Lilly and Company
Clinicaltrials.gov Identifier
Research summary
Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) is the most common form of adult leukemia in the Western world (30-40% of all leukemia). Gold standard treatment with BTK inhibitor still results in acquired resistance and toxicity. Pirtobrutinib is a novel BTK inhibitor.
This is a Phase 2, open-label, randomised study evaluating the efficacy and safety of different dose levels of pirtobrutinib in participants with relapsed or refractory CLL/SLL, who have received 1-3 lines of treatment, including a covalent BTK inhibitor. This study will further evaluate the safety, tolerability, and efficacy of 3 different dosages of pirtobrutinib, 200 mg, 120 mg, and 60 mg, once daily.
Approximately 249 participants will be randomly assigned in a 1:1:1 ratio to study intervention.REC name
London - Central Research Ethics Committee
REC reference
24/LO/0725
Date of REC Opinion
28 Oct 2024
REC opinion
Further Information Favourable Opinion