Phase 3 Study Comparing Rocbrutinib to Other BTK Inhibitors for Adults With Relapsed or Refractory Mantle Cell Lymphoma

What this Trial Is About

Mantle cell lymphoma MCL is a type of B-cell non-Hodgkin lymphoma that can be aggressive or slow progressing. Researchers are evaluating Rocbrutinib, a new selective Brutons tyrosine kinase BTK inhibitor with both irreversible and reversible binding, in comparison to other BTK inhibitors ibrutinib, acalabrutinib, zanubrutinib, or orelabrutinib for patients with relapsed or refractory MCL who have had at least one prior treatment and have not previously received BTK inhibitors except for intolerance. This study is a Phase 3, randomized, open-label trial aimed at assessing these treatments in this patient group. Participants will be randomly assigned to receive either Rocbrutinib at 150 mg once daily orally or one of the investigators choice of BTK inhibitors, dosed continuously as per standard regimens ibrutinib 560 mg once daily, acalabrutinib 100 mg twice daily, zanubrutinib 160 mg twice daily, or orelabrutinib 150 mg once daily. Treatment will continue until disease progression or unacceptable side effects occur. The study compares the effects of these treatments on disease control and safety. During the trial, participants will be monitored closely with assessments including progression-free survival evaluated by an independent review committee over about 30 months. Other measurements include overall response rates, duration of response, overall survival, and tracking of treatment-emergent and treatment-related adverse events for up to approximately 40 months. Participants will follow scheduled visits and evaluations to support safety and effectiveness monitoring throughout the study.

A Study of Rocbrutinib Versus Investigator's Choice of BTK Inhibitors in Patients With Relapsed or Refractory Mantle Cell Lymphoma