Polatuzumab, Rituximab and Orelabrutinib Combination Regimen (PRO) in the Treatment of Elderly Frail Patients with Treatment-naive Non-GCB DLBCL
Trial Parameters
Brief Summary
This prospective, single-arm, multicenter clinical study aims to enroll 30 frail elderly patients with Non-GCB DLBCL. This study is to evaluate the preliminary efficacy and safety of the combination of Polatuzumab, Rituximab, and orelabrutinib in this population. The primary endpoint is CR rate after induction therapy.
Eligibility Criteria
Inclusion Criteria: * Patients with histopathologically confirmed DLBCL; * The sGA evaluation result of octogenarians or 60-79 years old is unfit or f RA il; * Non-germinal center (Non-GCB) type; * ECOG performance status score of 0-3 points; ⑤ No previous treatment for Lymphoma (unless glucocorticoid); 6 Radiographic Investigation to measurable disease, defined as the longest diameter with at least one Lymph node disorder \> 1.5 cm, or at least one extranodal lesion \> 1.0 cm in the longest diameter; ⑦ Adequate organ function; * Life expectancy ≥ 12 weeks; ⑨ Signed written informed consent. Exclusion Criteria: * Accompanied by uncontrolled cardiovascular and cerebrovascular diseases, Coagulopathy diseases, autoimmune diseases and severe Immunization diseases, etc.; * Laboratory abnormalities at screening (unless caused by Lymphoma) A) ANC \< 1.5 x 109/L, PLT \< 80 x 109/L b） Coagulation: INR greater than 1.5 x upper limit of normal; PT and APTT greater than 1.5 x upper limit of normal