Pomalidomide, Rituximab and Orelabrutinib Combined With Polatuzumab Vedotin in the Treatment of Newly Diagnosed Elderly Patients With DLBCL

The study will start with an initial 21-days of induction therapy with Pro regimen (Pomalidomide, rituximab and orelabrutinib)，following imaging examinations to evaluate response rates. Patients with a lesion reduction of ≥25% received Pro-pola(Pro regimen plus polatuzumab vedotin), in a 21-day cycle for 6 cycles.

Inclusion criteria

• Age ≥70 years unfit or frail
• There is at least one image-measurable lesion with a measurable lesion of at least 15 mm.
• Histologically confirmed treatment-naive DLBCL.
• Life expectancy is>3 months.
• appropriate organ function: Cardiac function: Cardiac ejection fraction ≥50%; Liver function: alanine aminotransferase and aspartate aminotransferase ≤3 times the upper limit of normal; Renal function: Serum creatinine clearance ≥30mL/min; Lung function: SPO2 >90% without oxygen inhalation
• Adequate bone marrow reserve is defined as:

Hemoglobin ≥8g/dL, platelet count ≥75×10^9/L, Absolute neutrophil value ≥1.0×10^9/L, If accompanied by bone marrow invasion, platelet count ≥50×10^9/L, absolute neutrophil count ≥0.75×10^9/L.

• Patients have the ability to understand and are willing to provide written informed consent.
• Subjects with childbearing or childbearing potential must be willing to practice birth control from the date of registration in this study to the follow-up period of the study.

Exclusion criteria

• Severe abnormal liver and kidney function (alanine aminotransferase, bilirubin, creatinine>3 times the upper limit of normal);
• Presence of organic heart disease or severe arrhythmia leading to clinical symptoms or abnormal cardiac function (NYHA Functional Class Grade ≥2);
• Uncontrolled active infection;
• Co-existence of other tumors requiring treatment or intervention;
• DLBCL involving central nervous system;
• Current or expected need for systemic corticosteroid treatment;
• Previous or current history of vascular embolism;
• Other psychological conditions that prevent the patient from participating in the study or signing informed consent.
• In the investigator's judgment, it is unlikely that the subject will complete all protocol-required study visits or procedures, including follow-up visits, or will not meet the requirements for participation in the study.