Tests a combined drug treatment for older adults with a type of lymphoma
Tests a combination drug treatment in adults aged 70 or older with lymphoma.
Plain-language title generated from the registry record
Registry title: Clinical Study of HiR+X Therapy for Newly Diagnosed Elderly Patients With DLBCL Intolerant to Chemotherapy
Key facts
- Where
- Ningbo, ChinaSee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 70 and 100 years old?
Source: NCT06758037, who can take part
Where in China
- The First Affiliated Hospital of Ningbo UniversityNingbo, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- First Affiliated Hospital of Ningbo University
- Trial code
- NCT06758037
- Record updated
- 18 March 2025
- Original description
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.Read full original descriptionShow less
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.
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.
Inclusion: Age ≥ 70 years; ECOG score 0-3; Rated as "unfit" or "frail" on the simplified geriatric assessment (sGA); Histologically confirmed CD20-positive diffuse large B-cell lymphoma [diagnostic criteria according to WHO 2016], excluding transformed type 2 DLBCL; Previously untreated, newly diagnosed patients; 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; At least one measurable lesion; Intolerance to standard CHOP chemotherapy regimen or unwillingness to receive chemotherapy; Sufficient understanding and voluntary signing of the informed consent form.
Exclusion: Patients with central nervous system involvement at the onset of the disease; Known human immunodeficiency virus (HIV) infection; Uncontrolled active infection; Active hepatitis with HBV-DNA copy number unable to be controlled within 2000/mL despite antiviral treatment; Pregnant or lactating women; Other tumors requiring treatment; Individuals who cannot understand, comply with the study protocol, or sign the informed consent form.