Evaluation of the Efficacy and Safety of Polatuzumab Vedotin Combined With Rituximab, Gemcitabine, and Oxaliplatin (Pola-R-GemOx) as Salvage Therapy for Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL) Patients Ineligible for Autologous Transplantation: A Prospective, Multicenter, Single-Arm Clinical Study
This is a prospective, multicenter, single-arm clinical study designed to evaluate the efficacy and safety of Polatuzumab Vedotin combined with Rituximab, Gemcitabine, and Oxaliplatin (Pola-R-GemOx) as salvage therapy for relapsed/refractory Diffuse Large B-Cell Lymphoma (DLBCL) patients ineligible for autologous transplantation.
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∙ Participants must meet all of the following criteria to participate in the study:
• Age ≥18 years old;
• ineligible for autologous transplantation;
• Sign the Informed Consent Form (ICF);
• CD79b-positive DLBCL confirmed by pathology (including transformed DLBCL, PMBL, HGBCL);
• Patients must have received adequate first-line treatment and only first-line treatment, with
‣ Anti-CD20 monoclonal antibodies (unless the investigator determines that the tumor is CD20-negative)
⁃ Chemotherapy regimens containing anthracyclines
• Recurrent or refractory diseases after first-line immunochemotherapy:
‣ Refractory disease is defined as not having a complete response to first-line therapy (except for patients who are intolerant to first-line therapy)
⁃ Recurrent disease is defined as disease recurrence after complete response to first-line treatment
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2, with an expected survival of more than 12 weeks.
• Have at least one measurable two-dimensional lesion identified by clinical examination, CT scan or MRI: ① lymph node \>1.5cm; ② Other non-lymph node lesions ≥1.0cm;
• The main tissues and organs function well:
∙ Hematological function: absolute granulocyte count ≥ 1,000/mm3, platelet count ≥ 75,000/mm3; Liver function: ALT/AST \< 3 times upper limit of normal (ULN) and total bilirubin ≤1.5× upper limit of normal (ULN) (\< 5 times ULN in patients with Gilbert syndrome, cholestasis due to hilar compression adenopathy, biliary obstruction due to liver involvement or lymphoma); Renal function: creatinine clearance \> 30 mL/min, creatinine ≤1.5× upper limit of normal (ULN) Lung function: indoor oxygen saturation ≥95%; Cardiac function: no obvious cardiac insufficiency or cardiovascular disease; 10. Fertile patients must be willing to use highly effective contraception during the study period and for 120 days after the last dose of treatment.