Study of Polatuzumab Vedotin with Zanubrutinib, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone for Untreated Diffuse Large B-Cell Lymphoma Subtypes MCD, BN2, and N1

What this Trial Is About

Researchers are evaluating the effectiveness and safety of a combination treatment for patients with previously untreated Diffuse Large B-Cell Lymphoma DLBCL of the MCD, BN2, or N1 molecular subtypes. This Phase II, open-label study aims to assess how well this new drug combination works and its safety profile in this specific group of lymphoma patients. The study is conducted at a single center and is sponsored by The First Affiliated Hospital with Nanjing Medical University. Participants will receive six cycles of a combination treatment called Pola-ZRCHP, which includes Polatuzumab Vedotin, Zanubrutinib, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone, with each cycle lasting 21 days. Rituximab is given for eight cycles overall. After the initial treatment phase, patients who have stable disease or better will continue to a maintenance phase where they receive Zanubrutinib and Tislelizumab for up to one year or until disease progression or unacceptable side effects occur. Patients whose disease does not respond adequately will stop the study treatment. During the study, participants will have their disease monitored through CT or PET-CT scans to assess response to treatment according to established criteria. Safety and tumor response will be regularly checked by investigators. The primary measure of success is the 2-year event-free survival rate, with additional outcomes including response rates and overall survival tracked over two years. Treatment-related side effects will be monitored from the start of treatment until 30 days after the last dose. Overall participation can last up to two years from the start of treatment.

Efficacy and Safety of Polatuzumab Vedotin in Combination With Zanubrutinib, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone in Patients With Previously Untreated Diffuse Large B-Cell Lymphoma of the MCD/BN2/N1 Subtypes