NCT06758037RecruitingPhase 2
Clinical Study of HiR+X Therapy for Newly Diagnosed Elderly Patients With DLBCL Intolerant to 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.
Source: ClinicalTrials.gov · Last updated 18 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 2 Jan 2025
- Start date
- 15 Jan 2025
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- First Affiliated Hospital of Ningbo University
- Diseases
- Diffuse large B-cell lymphoma
- NCT number
- NCT06758037
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 50
- From 15 Jan 2025 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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;
Other
- Pregnant or lactating women;
- Other tumors requiring treatment;
- Individuals who cannot understand, comply with the study protocol, or sign the informed consent form.
Who the study is looking for
- 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.
Age in the registry: 70 years to 100 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital of Ningbo University Coordinator of this site? Confirm its status | Ningbo | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.