About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Single group
Treatments tested in this trial
Drug therapy
DrugAll patients will receive one cycle of HiR (Zebtorizumab, Lenalidomide) induction therapy. On the first day of enrollment, tissue NGS and peripheral blood ctDNA will be submitted for testing. For the remaining six cycles, the added drug (X) will be determined based on the NGS molecular typing results. Please refer to the grouping scheme for details. HiR+X Dosing Scheme: Hi: Zebtorizumab 375mg/m², d1; R: Lenalidomide 10-25mg d1-10 (maximum tolerated dose) X: For MCD/BN2/TP53: Ocalivumab 150mg qd For EZB: Chidamide 30mg biw For N1-like and nonspecific types: If EBV-positive: PD-1 monoclonal antibody 200mg Q3W
Treatment groups
Trial outcomes
Primary outcomes
Complete response rate (CR) at the end of 6 cycles
Complete response rate (CR) at the end of 6 cycles
Sponsors and contacts
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