Phase II Study of HiRX Therapy for Older Adults 70 with Newly Diagnosed Diffuse Large B-Cell Lymphoma Unfit for Chemotherapy

What this Trial Is About

Researchers are evaluating the use of HiR Zebtorizumab, Lenalidomide combined with a targeted drug X guided by next-generation sequencing NGS molecular typing to assess therapeutic effects and safety in newly diagnosed elderly patients aged 70 years and older with diffuse large B-cell lymphoma DLBCL who are unfit or frail and intolerant to chemotherapy. The study also aims to identify genetic subtypes that may benefit from this HiR-X therapy. All participants will first receive one cycle of HiR induction therapy. On enrollment day, tissue and blood samples will be collected for NGS testing. Then, over six additional cycles, the targeted drug X will be selected based on the molecular typing results. Dosing includes Zebtorizumab 375mgm on day 1 and Lenalidomide 10-25mg on days 1-10 per cycle. The X drug varies by subtype Ocalivumab for MCDBN2TP53 types, Chidamide for EZB type, and PD-1 monoclonal antibody for EBV-positive N1-like and nonspecific types. Participants will be monitored throughout the six 21-day cycles, with assessments focused on the complete response rate after treatment completion. Safety evaluations, tissue and blood molecular testing, and clinical observations will guide therapy adjustments. The study is planned to continue until June 2027, and participants will be followed to assess therapy response and monitor overall health and treatment tolerability.

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