A Single-arm, Multicenter Phase II Clinical Study of HiR+X Therapy for Newly Diagnosed Diffuse Large B-cell Lymphoma (DLBCL) in Elderly Patients Intolerant to Chemotherapy, Guided by Molecular Subtyping and Clinical Characteristics.
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.
• 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.