NCT06757894尚未招募2 期
Efficacy and Safety of Zuberitamab and Bendamustine Combination Treatment Followed by Monotherapy Maintenance in Treatment-naïve Follicular Lymphoma: an Open-label, Prospective, Multicenter, Single-arm Phase II Clinical Study
Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年2月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Complete Response (CR)
研究概览
简要总结
This is a prospective, single-arm, multicenter, phase ll clinical trial to evaluate the efficacy and safety of Zuberitamab and Bendamustine combination treatment in treatment-naïve follicular lymphoma patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntary signing of informed consent.
- •Age ≥ 18 years, no gender restriction.
- •Histologically confirmed follicular lymphoma (grades 1-3a), CD20 positive by immunohistochemistry.
- •No prior systemic treatment for FL.
- •Ann Arbor stage III/IV, or stage II with bulky disease (bulky disease defined as a tumor diameter ≥ 7 cm).
- •Presence of measurable lesions.
- •Meeting any of the following criteria:
- •B symptoms: unexplained fever >38°C, night sweats, unexplained weight loss >10% in the last 6 months.
- •Abnormal signs: splenomegaly, pleural effusion, ascites, etc.
- •Major organ damage: involvement of major organs leading to organ dysfunction.
- •Hematologic involvement: cytopenia [WBC < 1.0 × 10⁹/L and/or PLT < 100 × 10⁹/L]; leukemia-like manifestations (malignant cells > 5.0 × 10⁹/L); elevated LDH levels; HGB < 120 g/L; β2-microglobulin ≥ 3 mg/L.
- •Bulky disease: involvement of ≥ 3 tumors with each diameter ≥ 3 cm, or any lymph node or extranodal tumor with diameter ≥ 7 cm (for Ann Arbor stage III-IV patients).
- •Tumor enlargement of 20%-30% within 2-3 months, or approximately 50% enlargement within 6 months.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or
- •Expected survival of > 6 months.
排除标准
- •History of allergy to any component of monoclonal antibodies or investigational drugs.
- •Central nervous system involvement.
- •History of previous malignant tumors.
- •Clinically significant cardiac or pulmonary diseases.
- •Infection requiring intravenous antibiotic treatment or hospitalization within 4 weeks prior to enrollment; or infection requiring oral antibiotics within 2 weeks prior to enrollment; or symptoms related to an infection within 1 week prior to enrollment.
- •Major surgery within 4 weeks prior to enrollment.
- •Vaccination with live vaccines within 4 weeks prior to enrollment or planned live vaccination during the study.
- •HIV antibody positive.
- •Active syphilis infection, TP antibody positive, and anti-TP treatment within the last 2 years.
- •Hepatitis C virus (HCV) antibody positive with HCV RNA quantitative test result exceeding the detection limit; Hepatitis B surface antigen (HBsAg) positive or Hepatitis B core antibody (HBcAb) positive, with Hepatitis B virus DNA quantitative test result exceeding the detection limit (for patients with HBsAg or HBcAb positive status, regardless of HBV-DNA detection, oral entecavir or other antiviral therapy must be initiated prior to enrollment and continued according to the physician's instructions during the trial).
- •Pregnant or breastfeeding women, or planning to become pregnant during the study.
- •Investigator determines the patient is unsuitable for enrollment or may not be able to complete the trial for other reasons.
研究组 & 干预措施
Zuberitamab and Bendamustine Combination Treatment
Experimental
Induction therapy:
- Zuberitamab: 375 mg/m², administered on Day 1 (D1) of Cycles 1-6 (C1-C6).
- Bendamustine: 90 mg/m², administered on D1-2 of C1-C6. Each cycle lasts 28 days. After 6 cycles of treatment, patients who achieve complete remission (CR) or partial remission (PR) will continue with maintenance therapy.
Maintenance therapy:
Zuberitamab: 375 mg/m², administered once every 2 months, until disease progression or for a maximum of 24 months (12 doses).
干预措施: Zuberitamab (Drug)
Zuberitamab and Bendamustine Combination Treatment
Experimental
Induction therapy:
- Zuberitamab: 375 mg/m², administered on Day 1 (D1) of Cycles 1-6 (C1-C6).
- Bendamustine: 90 mg/m², administered on D1-2 of C1-C6. Each cycle lasts 28 days. After 6 cycles of treatment, patients who achieve complete remission (CR) or partial remission (PR) will continue with maintenance therapy.
Maintenance therapy:
Zuberitamab: 375 mg/m², administered once every 2 months, until disease progression or for a maximum of 24 months (12 doses).
干预措施: Bendamustine (Drug)
结局指标
主要结局
Complete Response (CR)
时间窗: Up to 6 cycles (each cycle is 28 days).
Defined as the proportion of patients who achieve complete remission at the end of induction therapy.
次要结局
- Objective Response Rate (ORR)(Up to 6 cycles (each cycle is 28 days).)
- Progression-Free Survival (PFS)(From the start of induction therapy to the first documented disease progression or death from any cause, whichever occurs first, assessed up to 78 months.)
- Event-Free Survival (EFS)(From the start of induction therapy to the first occurrence of any event, including disease progression, discontinuation of treatment, or death for any reason, whichever occurs first, assessed up to 78 months.)
- Duration of Response (DOR)(From the first documentation of CR or PR to the first documented disease progression, assessed up to 78 months.)
- Overall Survival (OS)(From the start of induction therapy to death from any cause, assessed up to 78 months.)
- Time to Next Treatment (TTNT)(From the start of induction therapy to the start of the next line of anti-tumor treatment, assessed up to 78 months.)
- Incidence and severity of Adverse Events (AE) and Serious Adverse Event (SAE)(From the start of induction therapy through the end of the maintenance therapy phase, up to 30 months.)
研究者
Qingqing Cai
chief physician
Sun Yat-sen University
研究点 (1)
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