Phase 12 Study of Acalabrutinib, Venetoclax, and Obinutuzumab for Relapsed, Refractory, or Untreated Mantle Cell Lymphoma

What this Trial Is About

Researchers are evaluating a combination of three drugsacalabrutinib, venetoclax, and obinutuzumabas a possible treatment for people with relapsed, refractory, or untreated mantle cell lymphoma MCL. This open-label, phase 12 study is designed to assess the safety and effectiveness of this combination, with a focus on determining the appropriate dose and measuring treatment responses. The study is expected to enroll about 72 participants and will include different groups based on prior treatment history and genetic markers related to TP53 mutation status. The study consists of four parts, each targeting specific groups of participants with mantle cell lymphoma. Participants will receive the three drugs on different schedules within 28-day treatment cycles acalabrutinib is given orally starting from cycle 1, venetoclax orally starting from cycle 3, and obinutuzumab via intravenous infusion starting from cycle 2. Treatment continues as long as there are no severe side effects and the disease does not worsen. Some participants will receive additional maintenance therapy. Follow-up will continue for up to five years to monitor long-term outcomes. Participants will undergo screening to confirm eligibility and will have regular evaluations throughout the study, including imaging scans, blood tests, and bone marrow samples. Researchers will monitor treatment response rates, minimal residual disease status, progression-free survival, overall survival, and safety measures such as adverse events and infusion reactions. The study includes detailed assessments over months and years to understand how participants respond to this treatment combination and to track any side effects or disease progression.

Avo In R/R And Previously Untreated MCL