Zanubrutinib, obinutuzumab and bendamustine as first treatment for chronic lymphocytic leukemia
Tests zanubrutinib, obinutuzumab and bendamustine in adults starting treatment for chronic lymphocytic leukemia.
Plain-language title generated from the registry record
Registry title: Phase II Trial of Zanubrutinib, Obinutuzumab, Bendamustine (ZGB) as First-Line Therapy for Chronic Lymphocytic Leukemia: A Single-Center Study
Key facts
- Where
- Changchun, ChinaSee the site
- Phase
- Phase 2
Where in China
- The First Hospital of Jilin UniversityChangchun, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- The First Hospital of Jilin University
- Trial code
- NCT07003464
- Record updated
- 4 June 2025
- Original description
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.Read full original descriptionShow less
Efficacy and Safety of Zanubrutinib, Obinutuzumab, and Bendamustine (ZGB) Regimen for First-Line Treatment of Chronic Lymphocytic Leukemia: A Single-Arm, Prospective Study
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.
Inclusion: Demographics: Age ≥18 years, regardless of gender; Diagnosis: Confirmed diagnosis of untreated chronic lymphocytic leukemia (CLL) per iwCLL 2018 criteria; 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); 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); Performance Status: ECOG performance status ≤2; 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); Consent: Signed informed consent.
Exclusion: Recent Surgery: Major surgery within 30 days; Malignancy: History of active malignancy (excluding CLL) within the past year, including CNS lymphoma; Disease Transformation: Richter transformation or prolymphocytic leukemia (PLL); Autoimmune Cytopenias: Active autoimmune hemolysis or thrombocytopenia requiring corticosteroids; Comorbidities: Uncontrolled diabetes, cardiac/pulmonary disease, or conditions deemed by investigators to affect study safety; Infections: Active systemic infection requiring IV antibiotics; Bleeding Risks: History of life-threatening hemorrhage or need for high-dose anticoagulation; Drug Tolerance: Hypersensitivity to any study drug components; Viral Infections: Active HBV (HBsAg+ or HBV-DNA+) or HCV; Other: Investigator-determined ineligibility (e.g., poor compliance, psychiatric disorders); Organ Dysfunction: ALT/AST >3×ULN; total bilirubin >2×ULN; creatinine >1.5×ULN; Reproductive Status: Pregnancy, lactation, or unwillingness to use contraception.