Actively Recruiting

Phase 2
Age: 70Years - 100Years
All Genders
NCT06758037

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

Led by First Affiliated Hospital of Ningbo University · Updated on 2025-03-18

50

Participants Needed

1

Research Sites

128 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 70Years - 100Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 70 years or older
  • ECOG performance status score between 0 and 3
  • Classified as "unfit" or "frail" by simplified geriatric assessment
  • Histologically confirmed CD20-positive diffuse large B-cell lymphoma (excluding transformed type 2 DLBCL)
  • Newly diagnosed and previously untreated
  • Cardiac, liver, and kidney function within specified normal limits (creatinine < 2x ULN; ALT/AST < 2.5x ULN; total bilirubin < 2x ULN)
  • At least one measurable tumor lesion
  • Intolerant to standard CHOP chemotherapy or unwilling to receive it
  • Able to understand and voluntarily sign informed consent form
Not Eligible

You will not qualify if you...

  • Central nervous system involvement at disease onset
  • Known HIV infection
  • Pregnant or breastfeeding women
  • Presence of other tumors requiring treatment
  • Uncontrolled active infection
  • Active hepatitis with HBV-DNA above 2000/mL despite antiviral therapy
  • Unable to understand or comply with study procedures or sign informed consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

The First Affiliated Hospital of Ningbo University

Ningbo, Zhejiang, China, 3150101

Actively Recruiting

Loading map...

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here