Clinical Research Directory

Inclusion Criteria: 1. Demographics: Age ≥18 years, regardless of gender. 2. Diagnosis: Confirmed diagnosis of untreated chronic lymphocytic leukemia (CLL) per iwCLL 2018 criteria. 3. Treatment Naivety: * No prior systemic therapy for CLL, including: * CHOP/COP-based chemotherapy. * Regimens containing fludarabine or bendamustine. * Anti-CD20 monoclonal antibodies (e.g., rituximab) or BTK inhibitors (e.g., ibrutinib). * Chlorambucil or cyclophosphamide (\>3 weeks of use). * Interferon therapy (\>6 months of use). 4. Treatment Indications: * Must meet ≥1 of the following (iwCLL 2018 criteria): * Hemoglobin \<100 g/L (non-hemolytic). * Platelets \<100×10⁹/L with progressive decline. * Lymphadenopathy (longest diameter \>10 cm) or massive splenomegaly (\>6 cm below costal margin). * Constitutional symptoms: unexplained fever (\>38°C ×2 weeks), night sweats, or \>10% weight loss in 6 months. * Rapid disease progression (lymphocyte doubling time \<6 months, 50% lymph node growth in 2 months, or rapid cytopenia). 5. Performance Status: ECOG performance status ≤2. 6. Organ Function (within 7 days before enrollment): Hematologic: * ANC ≥1.0×10⁹/L (without growth factor support). * Platelets ≥50×10⁹/L (without transfusion). * Hepatic: AST/ALT ≤2.5×ULN; total bilirubin ≤1.5×ULN. * Renal: Estimated CrCl ≥30 mL/min (Cockcroft-Gault formula). 7. Consent: Signed informed consent. Exclusion Criteria: 1. Malignancy: History of active malignancy (excluding CLL) within the past year, including CNS lymphoma. 2. Disease Transformation: Richter transformation or prolymphocytic leukemia (PLL). 3. Autoimmune Cytopenias: Active autoimmune hemolysis or thrombocytopenia requiring corticosteroids. 4. Organ Dysfunction: ALT/AST \>3×ULN; total bilirubin \>2×ULN; creatinine \>1.5×ULN. 5. Comorbidities: Uncontrolled diabetes, cardiac/pulmonary disease, or conditions deemed by investigators to affect study safety. 6. Infections: Active systemic infection requiring IV antibiotics. 7. Bleeding Risks: History of life-threatening hemorrhage or need for high-dose anticoagulation. 8. Recent Surgery: Major surgery within 30 days. 9. Reproductive Status: Pregnancy, lactation, or unwillingness to use contraception. 10. Drug Tolerance: Hypersensitivity to any study drug components. 11. Viral Infections: Active HBV (HBsAg+ or HBV-DNA+) or HCV. 12. Other: Investigator-determined ineligibility (e.g., poor compliance, psychiatric disorders).