EUCTR2010-023407-95-ES进行中（未招募）1 期
A Phase IIIb, randomized study comparing maintenance therapy with subcutaneous rituximab continued until progression and observation in patients with relapsed or refractory, indolent non-Hodgkin's lymphoma who completed and responded to a 6-month rituximab-based immunochemotherapy induction and initial 2-year rituximab maintenance therapy administered subcutaneously.
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 700
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Age ? 18 years.
- •- Histologically confirmed, CD20+ follicular NHL Grade 1, 2 or 3a, or other CD20+ indolent NHL (Waldenström's macroglobulinemia or lymphoplasmacytic lymphoma, marginal zone lymphoma) according to the WHO classification system, other not further classified low malignant lymphoma by immunohistochemistry.
- •- Patients must have received and must have relapsed or been refractory to one or more lines of adequate induction therapy prior to enrolment, including at least one line consisting of immunotherapy and/or chemotherapy.
- •- Eastern Cooperative Oncology Group (ECOG) performance status < or = 2.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 420
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 280
排除标准
- •- Transformation to high-grade lymphoma.
- •- Patients with aggressive lymphoma (e.g. mantle cell lymphoma).
- •- Presence or history of central nervous system (CNS) lymphomatous disease (e.g., CNS lymphoma or lymphomatous meningitis).
- •- Other malignancy within 5 years prior to enrolment, with the following exceptions (as long as curatively treated): carcinoma in situ of the cervix, squamous cell carcinoma of the skin, or basal cell skin cancer.
- •Cervical carcinoma stage 1B or less, breast cancer in situ, or localized prostate cancer stage T1c or less may be considered, provided that the patient was treated with curative intent and has been relapse- and metastasis-free for at least 2 years prior to enrolment.
- •- Inadequate hepatic or renal function prior to the first rituximab
- •induction dose.
- •- Known human immunodeficiency virus (HIV) infection.
研究者
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