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Clinical Study of HiR+X Therapy for Newly Diagnosed Elderly Patients With DLBCL Intolerant to Chemotherapy

RecruitingPhase 2Ages 70 Years - 100 YearsAllFirst Affiliated Hospital of Ningbo University
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In plain words

What the trial is, and whether it could suit you

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 โ‰ฅ70 years, and to investigate the genetic subtypes that may benefit from HiR-X.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Age โ‰ฅ 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.
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What it tests

  • Drug therapy
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Where

1 site
The First Affiliated Hospital of Ningbo University
Ningbo, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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