Rituximab Maintenance Versus Observation After R2 Induction in Previously Untreated Marginal Zone Lymphoma (ROMA)
2026年6月12日 更新者：Qingqing Cai、Sun Yat-sen University
Rituximab Maintenance Versus Observation After Rituximab and Lenalidomide (R2) Induction in Previously Untreated Marginal Zone Lymphoma: A Multicenter, Phase 2, Randomized Trial
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.
研究概览
研究类型
介入性
注册 (估计的)
144
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Cai Qingqing
- 电话号码：(020)87342823
- 邮箱：caiqq@sysucc.org.cn
学习地点
-
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Guangdong
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Guangzhou、Guangdong、中国、510060
- Sun Yat-sen University Cancer Center
-
接触：
- Principal investigator
- 电话号码：0086-20-87342823
- 邮箱：caiqq@sysucc.org.cn
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- 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 0-2.
- Adequate organ function.
Exclusion Criteria:
- 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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Rituximab
Patients will receive induction therapy with rituximab and lenalidomide.
If CR or PR: maintenance therapy with rituximab every 8 weeks for 2 years.
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Patients will receive R2 induction therapy consisting of rituximab and lenalidomide.
Patients who achieve complete response or partial response after induction will receive rituximab maintenance every 8 weeks for up to 2 years.
|
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有源比较器：Observation
Patients will receive induction therapy with rituximab and lenalidomide.
If CR or PR: observation.
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Patients will receive R2 induction therapy consisting of rituximab and lenalidomide.
Patients who achieve complete response or partial response after induction will undergo observation without maintenance anti-lymphoma therapy.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
2-year progression-free survival rate
大体时间：At 2 years after randomization
|
The 2-year progression-free survival rate is defined as the proportion of patients who are alive without disease progression at 2 years after randomization.
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At 2 years after randomization
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Complete response rate
大体时间：Up to 24 months after randomization
|
Complete response rate is defined as the proportion of patients who achieve complete response according to the Lugano 2014 criteria during the maintenance or observation period.
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Up to 24 months after randomization
|
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Overall response rate
大体时间：Up to 24 months after randomization
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Overall response rate is defined as the proportion of patients who achieve complete response or partial response according to the Lugano 2014 criteria during the maintenance or observation period.
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Up to 24 months after randomization
|
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Duration of response
大体时间：Up to 24 months after randomization
|
Duration of response is defined as the time from the first documented complete response or partial response to disease progression, relapse, or death from any cause, whichever occurs first.
|
Up to 24 months after randomization
|
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Overall survival
大体时间：Up to 24 months after randomization
|
Overall survival is defined as the time from randomization to death from any cause.
|
Up to 24 months after randomization
|
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Event-free survival
大体时间：Up to 24 months after randomization
|
Event-free survival is defined as the time from randomization to disease progression, relapse, initiation of new systemic anti-lymphoma therapy, or death from any cause, whichever occurs first.
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Up to 24 months after randomization
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Disease-free survival
大体时间：Up to 24 months after randomization
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Disease-free survival is defined as the time from the first documented complete response to disease relapse, progression, or death from any cause, whichever occurs first.
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Up to 24 months after randomization
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Incidence of progression of disease within 24 months
大体时间：Within 24 months from the start of induction therapy
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POD24 is defined as the proportion of patients who experience disease progression, relapse, or death from any cause within 24 months from the start of frontline induction therapy.
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Within 24 months from the start of induction therapy
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Patient-reported outcomes
大体时间：Up to 24 months after randomization
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Patient-reported outcomes will be assessed using the EORTC QLQ-C30 questionnaire.
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Up to 24 months after randomization
|
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Incidence of adverse events and serious adverse events
大体时间：Up to 30 days after the last study treatment or during follow-up as clinically indicated
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The incidence and severity of adverse events and serious adverse events will be assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0.
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Up to 30 days after the last study treatment or during follow-up as clinically indicated
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年7月1日
初级完成 (估计的)
2030年7月1日
研究完成 (估计的)
2031年7月1日
研究注册日期
首次提交
2026年6月12日
首先提交符合 QC 标准的
2026年6月12日
首次发布 (实际的)
2026年6月17日
研究记录更新
最后更新发布 (实际的)
2026年6月17日
上次提交的符合 QC 标准的更新
2026年6月12日
最后验证
2026年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.