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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age70-100
SponsorFirst Affiliated Hospital of Ningbo University

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Drug therapy

    Drug

    All 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

50 Participants
are divided into 1 treatment group
Group A: Patients with newly diagnosed, CD20+, elderly, chemotherapy-intolerant DLBCLExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Complete response rate (CR) at the end of 6 cycles

Complete response rate (CR) at the end of 6 cycles

Time frame
Each cycle consists of 21 days, with a total of 6 cycles.

Secondary outcomes

Other outcomes

Sponsors and contacts

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