RecruitingPhase 2NCT06758037

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

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.

Sponsor

First Affiliated Hospital of Ningbo University

Enrollment

50 participants

Start Date

Jan 15, 2025

Study Type

INTERVENTIONAL

Conditions

DLBCL

Summary

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

Min Age: 70 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a chemotherapy-free treatment regimen (rituximab plus a targeted drug combination called HiR+X) for elderly patients aged 70 and older with a type of blood cancer called diffuse large B-cell lymphoma (DLBCL) who are too frail to tolerate standard chemotherapy. **You may be eligible if...** - You are 70 or older - You have newly diagnosed, previously untreated CD20-positive DLBCL - You are considered "unfit" or "frail" based on a geriatric assessment - You are unwilling or unable to receive standard chemotherapy (CHOP regimen) - You have at least one measurable tumor **You may NOT be eligible if...** - Your cancer has spread to the brain or spinal cord - You have HIV - You are pregnant or breastfeeding - You have another cancer requiring treatment - You have uncontrolled active infection or poorly controlled hepatitis B Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDrug therapy

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

Locations(1)

The First Affiliated Hospital of Ningbo University

Ningbo, Zhejiang, China

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NCT06758037

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