Treatment for elderly patients with DLBCL who can't tolerate 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.
This study is testing a new combination treatment for older patients with diffuse large B-cell lymphoma who can't handle traditional chemotherapy to see if it can help them.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 70 Years to 100 Years |
| Sex | All |
| Sponsor | First Affiliated Hospital of Ningbo University Research network |
| Drugs / interventions | chemotherapy, Zebtorizumab |
| Locations | 1 site (Ningbo, Zhejiang) |
| Trial ID | NCT06758037 on ClinicalTrials.gov |
What this trial studies
This clinical study investigates the effectiveness and safety of a combination therapy called HiR+X, which includes Zebtorizumab and Lenalidomide, for elderly patients aged 70 and older who have been newly diagnosed with diffuse large B-cell lymphoma (DLBCL) and are considered unfit for standard chemotherapy. The approach is guided by next-generation sequencing (NGS) molecular typing to identify genetic subtypes that may respond better to the treatment. The study aims to provide an alternative therapeutic option for this vulnerable patient population.
Who should consider this trial
Good fit: Ideal candidates are elderly patients aged 70 and older with newly diagnosed, histologically confirmed CD20-positive DLBCL who are deemed unfit or frail.
Not a fit: Patients with central nervous system involvement, HIV infection, or those who are pregnant or lactating may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a new, effective option for elderly patients with DLBCL who cannot tolerate traditional chemotherapy.
How similar studies have performed: While this approach is innovative, similar studies exploring targeted therapies for DLBCL in elderly populations have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Ningbo, Zhejiang
- The First Affiliated Hospital of Ningbo University — Ningbo, Zhejiang, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.