EUCTR2017-002290-19-DE进行中(未招募)1 期
A Phase 3b randomized study of lenalidomide (CC-5013) plus rituximab maintenance therapy followed by lenalidomide single-agent maintenance versus rituximab maintenance in subjects with relapsed/refractory follicular, marginal zone or mantle cell lymphoma.
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
- 450
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 Follicular Lymphoma (Grade 1, 2 or 3a), Marginal Zone Lymphoma, or Mantle Cell Lymphoma
- •Must have documented relapsed, refractory or Progressive Disease after last treatment with systemic therapy
- •Bi-dimensionally measurable disease
- •Eastern Cooperative Oncology Group (ECOG) Performance status = 2
- •Adequate bone marrow function
- •Willingness to follow pregnancy precautions
- •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 220
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 280
排除标准
- •Histology other than follicular or marginal zone lymphoma or clinical evidence of transformation or Grade 3b follicular lymphoma
- •Any medical condition (other than the underlying lymphoma) that requires chronic steroid use
- •Subjects taking corticosteroids during the last 1 week prior treatment, unless administered at a dose equivalent to < 20 mg/day of prednisone
- •Systemic anti-lymphoma therapy within 28 days or use of antibody agents within 8 weeks use of radioimmunotherapy within 3 months
- •Known seropositive for or active viral infection with hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV)
- •Known sensitivity or allergy to murine products
- •Presence or history of central nervous system involvement by lymphoma. Subjects who are at a risk for a thromboembolic event and are not willing to take prophylaxis for it.
- •Any condition that places the subject at unacceptable risk if he/she were to participate in the study or that confounds the ability to interpret data from the study.
研究者
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