Study of Acalabrutinib and Obinutuzumab for Chinese Adults with Untreated Chronic Lymphocytic Leukemia

What this Trial Is About

Researchers are evaluating the combination of acalabrutinib and obinutuzumab in people with previously untreated chronic lymphocytic leukemia CLL. This study aims to assess how well this treatment works and its safety for patients who meet specific clinical criteria for needing treatment. The study is led by The First Affiliated Hospital with Nanjing Medical University and is designed as a single-arm, prospective trial. Participants will receive acalabrutinib capsules taken by mouth once daily in 28-day cycles for up to 24 months, unless side effects or disease progression occur first. Along with acalabrutinib, obinutuzumab will be given intravenously following a specific schedule for up to 6 cycles. Dose adjustments are possible based on tolerance. The study includes screening, treatment, and follow-up phases to monitor participants throughout their involvement. During the study, participants will undergo regular evaluations including blood tests and clinical assessments to monitor their response to treatment and safety. Researchers will measure outcomes such as progression-free survival at 24 months, overall survival, response rates, and any side effects experienced. Participants will be followed for up to 24 months to assess these outcomes and support safety monitoring throughout the treatment period.

A Single Arm Study of Acalabrutinib Conbimed With Obinutuzumab in Chinese Patients With Previously Untreated CLL