A Prospective, Phase II Clinical Study Protocol of Orelabrutinib Combined With Standard Immunochemotherapy With or Without Autologous Hematopoietic Stem Cell Transplantation (Auto-HSCT) for Newly Diagnosed Diffuse Large B-cell Lymphoma (DLBCL)
This study is a prospective, open-label, multicenter study in previously untreated participants with CD20-positive DLBCL. Orelabrutinib combined with standard immunochemotherapy with or without autologous hematopoietic stem cell transplantation (auto-HSCT) for newly diagnosed diffuse large B-cell lymphoma (DLBCL). The primary objective is to explore the 1-year progression-free survival (PFS) of orelabrutinib combined with standard immunochemotherapy with or without auto-HSCT in newly diagnosed DLBCL.
• Signed informed consent;
⁃ Age 18-80 years at the time of signing informed consent, and willingness to comply with the study protocol procedures;
‣ Pathologically confirmed CD20-positive DLBCL;
‣ ④ IPI score of 2-5;
‣ ⑤ ECOG performance status of 0-2;
‣ ⑥ Life expectancy ≥12 months;
‣ ⑦ Left ventricular ejection fraction (LVEF) ≥50% as assessed by multigated acquisition (MUGA) scan or echocardiography (ECHO);
∙ Adequate hematologic function (unless due to underlying disease, e.g., extensive bone marrow involvement, or hypersplenism secondary to splenic involvement attributed to DLBCL as determined by the investigator; transfusion of blood products is permitted), defined as follows:
⁃ Hemoglobin ≥90 g/L within 7 days prior to enrollment without packed red blood cell transfusion;
• Absolute neutrophil count (ANC) ≥1.0 × 10⁹/L;
• Platelet count ≥75 × 10⁹/L.
⁃ ⑨ Adequate organ function.