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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zanubrutinib | Drug | 160 mg (2 tablets) BID. Each 4-week period constitutes one treatment cycle. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Assessed at the end of Cycle 6 (each cycle = 28 days). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Assessed every 2 cycles during treatment and confirmed at Cycle 6 (each cycle = 28 days) |
| Complete Response Rate (CRR) |
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Inclusion Criteria:
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.
Organ Function (within 7 days before enrollment):
Hematologic:
Consent: Signed informed consent.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ou Bai, MD/PHD | Contact | 13039046656 | oubai16@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Hospital of Jilin University | Changchun | Jilin | 130021 | China |
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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.
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| 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. |
|
Proportion of participants achieving CR (normalization of blood counts, lymph nodes/spleen size, and bone marrow with <30% lymphocytes). |
| 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. | Evaluated every 3 months post-treatment for up to 3 years. |
| Overall Survival (OS) | Time from enrollment to death from any cause. | 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. | From first dose to 30 days after last dose. |
| ID | Term |
|---|---|
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| ID | Term |
|---|---|
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000629551 | zanubrutinib |
| C543332 | obinutuzumab |
| D000069461 | Bendamustine Hydrochloride |
| ID | Term |
|---|---|
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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