Phase 3 Study Comparing Rocbrutinib and Pirtobrutinib for Adults with Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Treated with Covalent BTK Inhibitors

What this Trial Is About

This research is a Phase 3, randomized, open-label, multicenter study comparing two treatments, rocbrutinib LP-168 and pirtobrutinib, in adults with relapsed or refractory chronic lymphocytic leukemia CLL or small lymphocytic lymphoma SLL who have previously received a covalent Brutons tyrosine kinase inhibitor cBTKi. The study addresses the challenge of disease progression or intolerance after cBTKi therapy, aiming to find effective and tolerable options for these patients. Approximately 306 participants will be involved, with treatment assignment balanced by key genetic and treatment history factors. Participants will be randomly assigned to receive either rocbrutinib 200 mg or pirtobrutinib 200 mg orally once daily in continuous 28-day cycles. Treatment will continue until disease progression, unacceptable side effects, withdrawal of consent, or other protocol-defined reasons for stopping. Crossover between treatment groups will not be allowed. The study includes stratification based on genetic markers, prior therapy discontinuation reasons, previous exposure to BCL2 inhibitors, and geographic region. Throughout the study, participants will be regularly evaluated for disease progression using specific criteria for CLL and SLL. Researchers will monitor overall survival, response rates, time to next treatment, and safety through various assessments including physical exams, lab tests, electrocardiograms, and adverse event reporting. Patient quality of life and biomarker studies will also be explored. The primary outcome, progression-free survival, is expected to be assessed for up to approximately four years, with safety monitored up to 30 days after the last dose.

ROCKET-CLL Global Phase 3 Study: Rocbrutinib vs Pirtobrutinib in cBTKi-Pretreated R/R CLL/SLL