NCT07654465尚未招募2 期
Rituximab Maintenance Versus Observation After Rituximab and Lenalidomide (R2) Induction in Previously Untreated Marginal Zone Lymphoma: A Multicenter, Phase 2, Randomized Trial
Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 144 人开始时间: 2026年7月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 144
- 试验地点
- 1
研究概览
简要总结
This is a multicenter, phase 2, randomized trial to compare rituximab maintenance with observation after rituximab and lenalidomide (R2) induction therapy in patients with previously untreated marginal zone lymphoma. Patients who achieve complete response or partial response after R2 induction will be randomized to receive rituximab maintenance or observation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Able to understand and voluntarily sign the informed consent form.
- •Age ≥18 years.
- •Histologically confirmed CD20-positive marginal zone lymphoma, including extranodal, splenic, or nodal subtypes.
- •Considered unsuitable for or unable to tolerate standard chemotherapy.
- •Previously untreated with systemic anti-lymphoma therapy.
- •Measurable or evaluable disease according to Lugano 2014 criteria.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-
- •Adequate organ function.
排除标准
- •History of other malignancies that may interfere with study assessment.
- •Central nervous system involvement by lymphoma.
- •Known HIV infection or active hepatitis B/C infection.
- •Active or uncontrolled infection.
- •Gastrointestinal condition that may interfere with oral administration or absorption of study treatment.
- •Pregnancy or breastfeeding.
研究者
Qingqing Cai
Professor and Chief Physician
Sun Yat-sen University
研究点 (1)
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