NCT06758037 Clinical Study of HiR+X Therapy for Newly Diagnosed Elderly Patients With DLBCL Intolerant to Chemotherapy
| NCT ID | NCT06758037 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | First Affiliated Hospital of Ningbo University |
| Condition | DLBCL |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-01-15 |
| Primary Completion | 2026-12-31 |
Trial Parameters
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
Brief Summary
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.
Eligibility 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 acti