Actively Recruiting
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
Eligibility Criteria
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
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
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, China, 3150101
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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