EUCTR2021-000362-15-DE进行中（未招募）1 期
Early Stage Follicular Lymphoma and Radiotherapy PLUS anti-CD20 Antibody
Ruprecht-Karls-University Heidelberg, Medical Faculty represented by Universitätsklinikum Heidelberg and its Commercial0 个研究点目标入组 130 人开始时间: 2021年12月16日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 130
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
- •Centrally reviewed CD20-positive follicular lymphoma grade 1/2 or 3a based on WHO classification (2008)
- •Untreated (radiation-, chemo- or immunotherapy) nodal follicular lymphoma (including involvement of Waldeyer´s ring)
- •Age: =18 years
- •ECOG: 0-2
- •Stage: clinical stage I or II (Ann Arbor classification) based on FDG-PET Staging
- •Risk profile: Largest diameter of the lymphoma = 7 cm (sectional images)
- •Written informed consent and willingness to cooperate during the course of the trial
- •Adequate bone marrow capacity: ANC = 1.5 x 103/ml, thrombocytes = 100000 x 10 3/ml, hemoglobin = 10 g/dL
- •Capability to understand the intention and the consequences of the clinical trial
- •Adequate contraception for men and women of child-bearing age during therapy and 18 months thereafter
- •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 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •?Extra nodal manifestation of follicular lymphoma
- •?Secondary cancer in the patient's medical history (exclusion: basalioma, spinalioma, melanoma in situ, bladder cancer T1a, non-metastasized solid tumor in constant remission, which was diagnosed >3 years ago)
- •?Serious disease interfering with a regular therapy according to the study protocol, e.g: congenital or acquired immune-deficiency syndromes, active infections including viral hepatitis, uncontrolled concomitant diseases including significant cardiovascular or pulmonary disease
- •?Severe psychiatric disease
- •?Pregnancy / lactation
- •?Known hypersensitivity against Obinutuzumab or Rituximab drugs with similar chemical structure or any other additive of the pharmaceutical formula of the study drug
- •?Active hepatitis B infection (inactive hepatitis B infections require additional prophylactic anti-viral medication for 1 year (e.g. Lamivudin, Entecavir, Tenofovir)
- •?Participation in another interventional trial or follow-up period of a competing trial which can influence the results of this current trial
研究者
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