Zanubrutinib: 160 mg (2 tablets) BID. Each 4-week period constitutes one treatment cycle.
Obinutuzumab: 1000 mg IV (Days 1, 8, 15 of Cycle 1; Day 1 thereafter).Each 4-week period constitutes one treatment cycle.
Bendamustine: 70 mg/m² (Days 1-2 per cycle) for induction only (Cycles 1-4).Each 4-week period constitutes one treatment cycle.
Study summary
This is a single arm, open label, national multicenter clinical study included patients with chronic lymphocytic leukemia (CLL). The treatment combines three medications: Zanubrutinib , Obinutuzumab and Bendamustine . Together, these drugs aim to achieve deep remission (no detectable cancer cells) and allow a shorter treatment duration compared to lifelong therapies.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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).
Primary outcome measure(s)
Undetectable Minimal Residual Disease (uMRD) Rate — Assessed at the end of Cycle 6 (each cycle = 28 days). Proportion of participants achieving uMRD (defined as \<1 CLL cell per 10,000 leukocytes \[\<0.01%\] via 8-color flow cytometry) in peripheral blood after 6 cycles of therapy.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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