Phase 2 Study of Acalabrutinib and Obinutuzumab for Untreated Low Tumor Burden Follicular Lymphoma and Other Indolent Non-Hodgkin Lymphomas

What this Trial Is About

Researchers are studying the effects of acalabrutinib and obinutuzumab in patients with previously untreated follicular lymphoma or other indolent non-Hodgkin lymphomas. This phase II trial aims to determine the treatments effectiveness, tolerability, and impact on quality of life. The study also explores long-term outcomes such as progression-free survival and the impact of discontinuing treatment after a complete response. During the induction phase, patients take acalabrutinib orally twice daily for 28-day cycles, up to 12 cycles, in combination with intravenous obinutuzumab given on specific days during cycles 3 to 8. After 12 cycles, patients who achieve a complete response are randomized to either stop or continue acalabrutinib alone. Those with partial or stable disease continue acalabrutinib monotherapy, while patients with disease progression discontinue treatment unless benefiting as judged by their doctor. Participants undergo regular assessments including tumor measurements and patient-reported outcomes throughout treatment and follow-up visits. After completing treatment, patients are monitored at 30 days, then every 12 weeks for one year, and every 6 months thereafter until disease progression or the start of new lymphoma treatment. Researchers measure response rates, adverse events, quality of life, and survival outcomes to evaluate the treatments overall impact.

Acalabrutinib and Obinutuzumab for the Treatment of Previously Untreated Follicular Lymphoma or Other Indolent Non-Hodgkin Lymphomas