Overview
To explore the application of HiR (Zebtorizumab, Lenalidomide) + X (targeted drug) guided by NGS molecular typing, the aim is to assess the therapeutic efficacy and safety in newly diagnosed unfit or frail elderly patients with DLBCL aged ≥70 years, and to investigate the genetic subtypes that may benefit from HiR-X.
Eligibility
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.