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

Sponsor
The First Hospital of Jilin University
Study ID
NCT07003464
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Jun 4, 2025
Start date
Jun 15, 2025
Status verified
Mar 2025
Primary completion
Jun 1, 2027
Completion
Jun 1, 2028

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: ZGB arm
    Single-arm, two-stage, MRD-adapted design to assess both safety and preliminary efficacy of the ZGB regimen. Structure: Sequential Two-Stage Intervention： Induction Phase (Cycles 1-4): All participants receive Zanubrutinib + Obinutuzumab + Bendamustine (ZGB). Consolidation Phase (Cycles 5-6): Only participants achieving peripheral blood uMRD (\<0.01% by flow cytometry) after Cycle 4 receive Zanubrutinib + Obinutuzumab (ZG); others discontinue treatment.

Primary Outcome Measure

Undetectable Minimal Residual Disease (uMRD) Rate [ Time Frame: Assessed at the end of Cycle 6 (each cycle = 28 days). ]

Central Contacts

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