Chronic Lymphocytic LeukemiaPhase 2NCT07003464
Phase II Trial of Zanubrutinib, Obinutuzumab, Bendamustine (ZGB) as First-Line Therapy for Chronic Lymphocytic Leukemia: A Single-Center Study
A Phase 2 study testing Zanubrutinib, Obinutuzumab and Bendamustine in people with Chronic Lymphocytic Leukemia, run by The First Hospital of Jilin University at 1 site in China.
Trial 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 . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Lymphocytic Leukemia
- What is being tested?
- Zanubrutinib, Obinutuzumab and Bendamustine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 15 Jun 2025to 1 Jun 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The First Hospital of Jilin University
Changchun, Jilin, 130021
Ou Bai, MD/PHD, 13039046656, oubai16@163.com
About this study
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
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.
- Conditions
- Chronic Lymphocytic Leukemia
- Being tested
- Zanubrutinib, Obinutuzumab, Bendamustine
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZanubrutinibDrug
160 mg (2 tablets) BID. Each 4-week period constitutes one treatment cycle.
ObinutuzumabDrug
1000 mg IV (Days 1, 8, 15 of Cycle 1; Day 1 thereafter).Each 4-week period constitutes one treatment cycle.
BendamustineDrug
70 mg/m² (Days 1-2 per cycle) for induction only (Cycles 1-4).Each 4-week period constitutes one treatment cycle.
| Study group | Role | What they receive |
|---|---|---|
| ZGB arm | Experimental | 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. Receives: Drug: Zanubrutinib; Drug: Obinutuzumab; Drug: Bendamustine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Undetectable Minimal Residual Disease (uMRD) Rate
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.
Measured: Assessed at the end of Cycle 6 (each cycle = 28 days).
Secondary outcomes (5)
Overall Response Rate (ORR)
Proportion of participants achieving complete response (CR), partial response (PR), or partial response with lymphocytosis (PR-L) per iwCLL 2018 criteria.
Measured: Assessed every 2 cycles during treatment and confirmed at Cycle 6 (each cycle = 28 days)
Complete Response Rate (CRR)
Proportion of participants achieving CR (normalization of blood counts, lymph nodes/spleen size, and bone marrow with <30% lymphocytes).
Measured: Assessed every 2 cycles during treatment and confirmed at Cycle 6 (each cycle = 28 days)
Progression-Free Survival (PFS)
Time from enrollment to disease progression (per iwCLL 2018) or death from any cause.
Measured: Evaluated every 3 months post-treatment for up to 3 years.
Overall Survival (OS)
Time from enrollment to death from any cause.
Measured: Follow-up until study completion (3 years).
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Frequency and severity of adverse events graded per NCI CTCAE v5.0.
Measured: From first dose to 30 days after last dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2025
- Study start15 Jun 2025 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lymphocytic LeukemiaStudies of the same condition, open and under way.
- More trials run by The First Hospital of Jilin UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This trial follows a 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.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ou Bai, MD/PHD, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07003464
- Sponsor's protocol ID
- HEM-2024-ZGB-01
- Status last verified
- Mar 2025
- First submitted
- 26 May 2025
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07003464
- Acronym / sponsor ID
- HEM-2024-ZGB-01
- Conditions
- Chronic Lymphocytic Leukemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The First Hospital of Jilin UniversityUniversity, hospital or other
- Study start
- 15 Jun 2025 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 4 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This trial follows a 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.
| Arm | Type | Receives |
|---|---|---|
| ZGB arm | Experimental | Drug: Zanubrutinib, Drug: Obinutuzumab, Drug: BendamustineSingle-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Demographics: Age ≥18 years, regardless of gender.
- Diagnosis: Confirmed diagnosis of untreated chronic lymphocytic leukemia (CLL) per iwCLL 2018 criteria.
- Treatment Naivety:
- Treatment Indications:
- Performance Status: ECOG performance status ≤2.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zanubrutinib160 mg (2 tablets) BID. Each 4-week period constitutes one treatment cycle. | Drug | ZGB arm |
| Obinutuzumab1000 mg IV (Days 1, 8, 15 of Cycle 1; Day 1 thereafter).Each 4-week period constitutes one treatment cycle. | Drug | ZGB arm |
| Bendamustine70 mg/m² (Days 1-2 per cycle) for induction only (Cycles 1-4).Each 4-week period constitutes one treatment cycle. | Drug | ZGB arm |
Primary outcome
Undetectable Minimal Residual Disease (uMRD) Rate
Time frame: 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.
5 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Zanubrutinib, Obinutuzumab and Bendamustine in people with Chronic Lymphocytic Leukemia, run by The First Hospital of Jilin University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ou Bai, MD/PHD (13039046656, oubai16@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Undetectable Minimal Residual Disease (uMRD) Rate (time frame: Assessed at the end of Cycle 6 (each cycle = 28 days).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2025.