A Phase 3 Open-Label, Randomized Study Comparing Rocbrutinib and Pirtobrutinib in Adults with Relapsed or Refractory CLL or SLL Previously Treated with Covalent BTK Inhibitors

What this Trial Is About

This trial investigates treatments for adults with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have previously received a covalent Bruton's tyrosine kinase inhibitor (cBTKi). It compares two oral drugs, rocbrutinib and pirtobrutinib, in a Phase 3, randomized, open-label study to assess their effectiveness and safety in this patient group. The study addresses the need for new options after cBTKi therapy failure or intolerance. Participants are randomly assigned to receive either rocbrutinib or pirtobrutinib at a dose of 200 mg once daily in continuous 28-day cycles. Treatment continues until disease progression, unacceptable side effects, withdrawal of consent, or other reasons for stopping. The study does not allow switching between treatments and stratifies randomization based on genetic mutations, prior treatment history, and geographic region. During the study, researchers will monitor disease progression using established criteria, assess overall survival, response rates, and safety through physical exams, lab tests, and questionnaires on quality of life. Adverse events and drug exposure will be closely evaluated. The study will last up to approximately four years from randomization, with regular assessments conducted throughout this period.

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