NCT01164267已完成2 期
A Multicenter Phase II Study to Evaluate the Clinical Activity and the Safety Profile of Everolimus (RAD001) in Marginal Zone B-cell Lymphomas (MZL) EudraCT Number 2009-011725-14
International Extranodal Lymphoma Study Group (IELSG)12 个研究点 分布在 3 个国家目标入组 30 人开始时间: 2010年3月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 12
- 主要终点
- Total Body CT-Scan
研究概览
简要总结
This is a multicenter open-label uncontrolled phase II study. There are no previous clinical data to estimate the expected response rate of everolimus in MALT lymphomas and in the other less common MZLs (i.e. nodal and splenic) refractory or relapsing after at least 1 prior systemic treatment (chemotherapy or immunotherapy).
The primary objective of this study is to define the antitumor activity, in term of overall response rate (ORR), as sum of complete remissions (CR) and partial remissions (PR) of everolimus in relapsed or refractory marginal zone B-cell lymphomas.
The secondary objectives of this study are to assess safety, as acute or long-term toxicity, response duration (RD) (time to relapse or progression) in responders and progression-free survival (PFS) (time to disease progression or death from any cause) in all 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
- •Histologically proven diagnosis of marginal zone B-cell lymphoma relapsing/refractory following at least 1 prior systemic treatment (chemotherapy and or monoclonal antibodies).
- •Any stage (Ann Arbor I-IV).
- •No evidence of histologic transformation to aggressive lymphoma.
- •Measurable or evaluable disease.
- •Age > 18 years.
- •Life expectancy of at least 3 months.
- •ECOG performance status 0-
- •No prior diagnosis of neoplasm within 5 years, except cervical type 1 intraepithelial neoplasia or localized non-melanomatous skin cancer.
- •In case of prior diagnosis of solid organ tumors, no treatment over the last 5 years ond no current evidence of disease.
- •No prior chemo-or radiotherapy in the last 6 weeks, no prior immunotherapy in the last 8 weeks, no corticosteroids during the last 4 weeks unless low-dose prednisone chronically administered for indications other than lymphoma or lymphoma-related symptoms.
- •No major impairment of bone marrow function, renal function or liver function unless due to lymphoma.
- •No evidence of active opportunistic infections, no HIV infection, no evidence of HBV infection, no active HCV infection.
- •Women of childbearing potential are using effective contraception, are not breast feeding, are not pregnant and agree not to become pregnant during participation in the trial and during the 12 months thereafter. A negative pregnancy test is mandatory for all patients < 50 years (unless considered unnecessary by the investigator).
- •Men agree not to father a child during participation in the trial and during the 12 months thereafter.
- •No serious cardiac, neurological or psychiatric disorders potentially hampering compliance with the study protocol and follow-up schedule.
- •Fasting serum cholesterol ≤ 200 mg/dL or ≤ 5 mmol/L AND fasting triglycerides ≤ 200 mg/dL. NOTE: In case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medication.
- •Written informed consent.
排除标准
- •Patients with newly diagnosed MZL.
- •Patients with concomitant or past hematological malignancies.
- •Presence or history of CNS lymphoma localization (either parenchymal or meningeal disease).
- •Cardiovascular disease (congestive heart failure; NYHA III or IV), unstable angina pectoris, significant cardiac arrhythmias requiring chronic treatment, or prior history of myocardial infarction in the last 3 months.
- •Serious underlying medical condition which could impair the ability of the patient to participate in the trial (e.g. uncontrolled diabetes mellitus, gastric ulcers, active autoimmune disease, ongoing infection e.g. HIV, hepatitis).
- •Concurrent anticancer drugs / treatments and experimental drugs. Previous radiation is allowed, unless the indicator lesion(s) are in the irradiated field.
- •Previous organ transplantation
- •Participation in another clinical trial within 30 days prior to trial entry
- •Pregnant or lactating women.
结局指标
主要结局
Total Body CT-Scan
时间窗: Every 12 weeks
次要结局
未报告次要终点
研究者
研究点 (12)
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