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

Last updated: March 16, 2025
Sponsor: First Affiliated Hospital of Ningbo University
Overall Status: Active - Recruiting

Phase

2

Condition

Lymphoma, B-cell

Lymphoma

Hematologic Cancer

Treatment

Drug therapy

Clinical Study ID

NCT06758037
2024-138A-02
2024-138A-02
  • Ages 70-100
  • All Genders

Study 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 Criteria

Inclusion

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 [diagnosticcriteria 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 xULN; total bilirubin < 2 x ULN;

  7. At least one measurable lesion;

  8. Intolerance to standard CHOP chemotherapy regimen or unwillingness to receivechemotherapy;

  9. Sufficient understanding and voluntary signing of the informed consent form.

Exclusion

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/mLdespite antiviral treatment;

  7. Individuals who cannot understand, comply with the study protocol, or sign theinformed consent form.

Study Design

Total Participants: 50
Treatment Group(s): 1
Primary Treatment: Drug therapy
Phase: 2
Study Start date:
January 15, 2025
Estimated Completion Date:
June 30, 2027

Connect with a study center

  • The First Affiliated Hospital of Ningbo University

    Ningbo, Zhejiang 3150101
    China

    Active - Recruiting

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