The Efficiency and Safety of Zanubrutinib in Combination With Polatuzumab Vedotin, Bendamustine and Rituximab in the Treatment of Relapsed/Refractory Diffuse Large B-cell Lymphoma: a Prospective, Single-arm, Multicenter Study
This is a prospective, multicenter, single-arm, open phase II study to explore the efficacy and safety of Zanubrutinib in combination with Polatuzumab Vedotin, bendamustine, and rituximab (Polo-ZBR) in subjects with relapsed/refractory diffuse large B-cell lymphoma. Subjects with relapsed/refractory DLBCL who met the inclusion/exclusion criteria were screened and treated with 4 courses of Pola-ZBR regimen after signing informed consent. Subjects achieving PR or CR were consolidated with autologous transplantation consolidation or the original regimen for 2 additional courses, and then given Zanubrutinib maintenance therapy for 1 year. The final follow-up was observed until 2 years after enrollment.
• Aged between 18 and 75 (inclusive);
• For patients with DLBCL confirmed by histopathology (which needs to be confirmed by specimens after this or past recurrence), the following DLBCL histology will be considered eligible for study enrollment:
⁃ DLBCL, NOS(includes GCB type and ABC type); T-cell rich large B-cell lymphoma; High-grade B-cell lymphoma with MYC and BCL-2 and/or BCL-6 rearrangement; High-grade B-cell lymphoma, NOS; Primary mediastinal (thymus) large B-cell lymphoma; EB virus positive DLBCL, NOS;HHV-8 positive DLBCL, NOS;
• Relapsed refractory patients, defined as those who had no response after first-line treatment (including immunochemotherapy, chemotherapy or hematopoietic stem cell transplantation) or relapsed or refractory after remission;
• There is at least one two-dimensional measurable lesion with a short diameter ≥1.0cm;
• Estimated survival time ≥3 months;
• The patient is informed and agrees to the program;
• ECOG score 0-2 points;
• Those who understand the procedure and content of the experiment, voluntarily participate in the study and sign the informed consent;
• Patients can follow up on schedule, communicate well with researchers and complete the trial according to the trial regulations;
• Confirm negative pregnancy test of female patients of childbearing age within 7 days before administration; Women and men in the reproductive period must agree to use medically recognized effective contraception throughout the treatment period and for 6 months after the end of the trial.