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Not yet recruiting NCT07003464

Phase II Trial of Zanubrutinib, Obinutuzumab, Bendamustine (ZGB) as First-Line Therapy for Chronic Lymphocytic Leukemia: A Single-Center Study

Phase II Interventional Chronic Lymphocytic Leukemia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Zanubrutinib, Obinutuzumab, Bendamustine.
Who it may be relevant to
Registry conditions: Chronic Lymphocytic Leukemia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Efficacy and Safety of Zanubrutinib, Obinutuzumab, and Bendamustine (ZGB) Regimen for First-Line Treatment of Chronic Lymphocytic Leukemia: A Single-Arm, Prospective Study

Overview

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.

Interventions

  • Drug Zanubrutinib
    160 mg (2 tablets) BID. Each 4-week period constitutes one treatment cycle.
  • Drug Obinutuzumab
    1000 mg IV (Days 1, 8, 15 of Cycle 1; Day 1 thereafter).Each 4-week period constitutes one treatment cycle.
  • Drug Bendamustine
    70 mg/m² (Days 1-2 per cycle) for induction only (Cycles 1-4).Each 4-week period constitutes one treatment cycle.

Primary outcome measures

  • Undetectable Minimal Residual Disease (uMRD) Rate [Time frame: Assessed at the end of Cycle 6 (each cycle = 28 days).]
Secondary outcome measures (5)
  • Overall Response Rate (ORR) [Time frame: Assessed every 2 cycles during treatment and confirmed at Cycle 6 (each cycle = 28 days)]
  • Complete Response Rate (CRR) [Time frame: Assessed every 2 cycles during treatment and confirmed at Cycle 6 (each cycle = 28 days)]
  • Progression-Free Survival (PFS) [Time frame: Evaluated every 3 months post-treatment for up to 3 years.]
  • Overall Survival (OS) [Time frame: Follow-up until study completion (3 years).]
  • Incidence of Treatment-Emergent Adverse Events (TEAEs) [Time frame: From first dose to 30 days after last dose.]

Eligibility criteria

Inclusion criteria

  • 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 criteria

  • 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.
  • Organ Dysfunction: ALT/AST >3×ULN; total bilirubin >2×ULN; creatinine >1.5×ULN.
  • 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.
  • Recent Surgery: Major surgery within 30 days.
  • Reproductive Status: Pregnancy, lactation, or unwillingness to use contraception.
  • 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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • The First Hospital of Jilin University — Changchun

Identifiers

NCT: NCT07003464 · HEM-2024-ZGB-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗