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;
Hemoglobin ≥90 g/L within 7 days prior to enrollment without packed red blood cell transfusion;
Presence of uncontrolled cardiovascular or cerebrovascular disease, coagulation disorders, autoimmune diseases, severe infectious diseases, etc.;
Coagulation function: INR > 1.5× the upper limit of normal (ULN); PT and APTT > 1.5× ULN;
Liver function: ALT or AST > 2× ULN; ALP and bilirubin > 1.5× ULN;
Renal function: Creatinine > 1.5× ULN; creatinine clearance < 60 mL/min (estimated by the Cockcroft-Gault formula);
Single group
Orelabrutinib combined with standard immunochemotherapy with or without auto-HSCT
Drug1+2.1 or 2.2 ±3 1\. Orelabrutinib: 150 mg once daily, orally, Days 1-28 2.1 Pola-R-CHP Regimen: Polatuzumab vedotin: 1.8 mg/kg, intravenous infusion, Day 1 Rituximab: 375 mg/m², intravenous infusion, Day 1 Cyclophosphamide: 750 mg/m², intravenous administration, Day 2 Doxorubicin: 50 mg/m², intravenous administration or per institutional guidelines, Day 2 Prednisone: 100 mg/day, orally, Days 2-6 2.2. R-CHOP Regimen: Rituximab: 375 mg/m², intravenous infusion, Day 0 Cyclophosphamide: 750 mg/m², intravenous administration, Day 1 Doxorubicin: 40-50 mg/m², intravenous administration or per institutional guidelines, Day 1 Vincristine: 1.4 mg/m², intravenous administration, Day 1 (maximum dose 2 mg) OR Vindesine: 4 mg, intravenous administration, Day 1 Prednisone: 100 mg/day, orally, Days 1-5 3\. auto-HSCT
1 year Progression free survival (PFS)
PFS is defined as the time from registration to the first occurrence of progression or relapse as assessed by the investigator, or death from any cause. PFS for patients without disease progression, relapse, or death will be censored at the time of the last tumor assessment.
ORR (Objective Response Rate)
ORR is defined as the proportion of patients with a response of CR or PR
CRR (Complete Response Rate)
CRR is defined as the proportion of patients with a best response of CR
2-year Progression free survival (PFS)
PFS is defined as the time from registration to the first occurrence of progression or relapse as assessed by the investigator, or death from any cause. PFS for patients without disease progression, relapse, or death will be censored at the time of the last tumor assessment.
2-year overall survival (OS)
Overall survival is defined as the period from the induction registration to death from any cause. Patients who have not died until the time of the analysis will be censored at their last contact date.
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