Clinical Study of HiR+X Therapy for Newly Diagnosed Elderly Patients With DLBCL Intolerant to Chemotherapy

Inclusion criteria

• Age ≥ 70 years;
• ECOG score 0-3;
• Rated as "unfit" or "frail" on the simplified geriatric assessment (sGA);
• Histologically confirmed CD20-positive diffuse large B-cell lymphoma [diagnostic criteria according to WHO 2016], excluding transformed type 2 DLBCL;
• Previously untreated, newly diagnosed patients;
• Cardiac, hepatic, and renal function: creatinine < 2 times the upper limit of normal (ULN); ALT (alanine aminotransferase) / AST (aspartate aminotransferase) < 2.5 x ULN; total bilirubin < 2 x ULN;
• At least one measurable lesion;
• Intolerance to standard CHOP chemotherapy regimen or unwillingness to receive chemotherapy;
• Sufficient understanding and voluntary signing of the informed consent form.

Exclusion criteria

• Patients with central nervous system involvement at the onset of the disease;
• Known human immunodeficiency virus (HIV) infection;
• Pregnant or lactating women;
• Other tumors requiring treatment;
• Uncontrolled active infection;
• Active hepatitis with HBV-DNA copy number unable to be controlled within 2000/mL despite antiviral treatment;
• Individuals who cannot understand, comply with the study protocol, or sign the informed consent form.