Clinical Study of HiR+X Therapy for Newly Diagnosed Elderly Patients With DLBCL Intolerant to Chemotherapy
Recruiting now · Phase 2
Conditions studied: DLBCL, Diffuse Large B-Cell Lymphoma
In brief
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.
Key facts
- Study ID
- NCT06758037
- Run by
- First Affiliated Hospital of Ningbo University
- People needed
- 50
- Starts
- 2025-01-15
- Expected to finish
- 2027-06-30
- Last updated by the study team
- 2025-03-18
Who can join
Age: 70 and older, up to 100. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- Patients with central nervous system involvement at the onset of the disease;
- Known human immunodeficiency virus (HIV) infection;
- Pregnant or lactating women;
- Other tumors requiring treatment;
- Uncontrolled active infection;
- Active hepatitis with HBV-DNA copy number unable to be controlled within 2000/mL despite antiviral treatment;
- Individuals who cannot understand, comply with the study protocol, or sign the informed consent form.
Where it is running
- The First Affiliated Hospital of Ningbo University — Ningbo, Zhejiang, China (enrolling)
Full record on ClinicalTrials.gov
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