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

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

Recruiting
70 years and older
All
Phase 2

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Overview

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

Inclusion Criteria:

  1. Age ≥ 70 years;
  2. ECOG score 0-3;
  3. Rated as "unfit" or "frail" on the simplified geriatric assessment (sGA);
  4. Histologically confirmed CD20-positive diffuse large B-cell lymphoma [diagnostic criteria according to WHO 2016], excluding transformed type 2 DLBCL;
  5. Previously untreated, newly diagnosed patients;
  6. 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;
  7. At least one measurable lesion;
  8. Intolerance to standard CHOP chemotherapy regimen or unwillingness to receive chemotherapy;
  9. Sufficient understanding and voluntary signing of the informed consent form.

Exclusion Criteria:

  1. Patients with central nervous system involvement at the onset of the disease;
  2. Known human immunodeficiency virus (HIV) infection;
  3. Pregnant or lactating women;
  4. Other tumors requiring treatment;
  5. Uncontrolled active infection;
  6. Active hepatitis with HBV-DNA copy number unable to be controlled within 2000/mL despite antiviral treatment;
  7. Individuals who cannot understand, comply with the study protocol, or sign the informed consent form.

Study details
    DLBCL
    Diffuse Large B-Cell Lymphoma

NCT06758037

First Affiliated Hospital of Ningbo University

15 October 2025

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