EUCTR2014-000128-22-FR进行中（未招募）1 期
A randomized phase III trial evaluating two strategies of rituximab administration for the treatment of first line/low tumor burden follicular lymphoma (Follicular Lymphoma IV/SC Rituximab Therapy) - FLIRT
YSARC0 个研究点目标入组 223 人开始时间: 2015年1月7日最近更新:
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
- 223
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
- •Histologically confirmed follicular lymphoma CD20+ grade 1, 2 and 3a by biopsy within 4 months before signing informed consent
- •Have a bone marrow biopsy within 4 months before the first study drug administration
- •Have no prior therapy except surgery for diagnosis
- •Aged 18 years or more with no upper age limit
- •ECOG performance status 0-2
- •Ann Arbor Stage II, III or IV
- •Bi-dimensionally measurable disease defined by at least one single node or tumor lesion > 1.5 cm assessed by CT scan and/or clinical examination
- •With low-tumor burden defined as:
- •- Nodal or extra-nodal mass with diameter less than 7 cm in its greater diameter
- •- And involvement of less than 3 nodal or extra nodal sites with diameter greater than 3 cm
- •- And absence of B symptoms
- •- And no symptomatic splenomegaly
- •- And no compression syndrome (ureteral, orbital, gastrointestinal…)
- •- And no pleural or peritoneal serous effusion
- •- And no cytopenia, with hemoglobin > 10 g/dL (6.25mmol/L), and absolute neutrophil count> 1.5 G/L and platelets > 100 G/L within 28 days before the randomization
- •- And LDH < ULN within 28 days before the randomization
- •- And ß2 microglobulin < ULN within 28 days before the randomization.
- •Have signed an informed consent
- •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 100
排除标准
- •Grade 3b follicular lymphoma
- •Ann Arbor Stage I
- •Seropositive for or active viral infection with hepatitis B virus (HBV) defined as:
- •- HBs Ag positive
- •- HBs Ag negative, anti-HBs antibody positive and/or anti-HBc antibody positive and detectable viral DNA
- •- Patients who are HBs Ag negative, anti-HBs positive and/or anti-HBc positive but viral DNA negative are eligible.
- •- Patients who are seropositive due to a history of hepatitis B vaccine are eligible.
- •Known seropositive for, or active viral infection with hepatitis C virus (HCV)
- •Known seropositive for, or active viral infection with Human Immunodeficiency virus (HIV)
- •Any of the following laboratory abnormalities within 28 days before the randomization:
- •- Total bilirubin or GGT or AST or ALT > 3 ULN.
- •- Calculated creatinine clearance (Cockcroft and Gault formula) < 60 mL /min
- •Presence or history of CNS involvement by lymphoma
- •Prior history of malignancies other than lymphoma (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast) unless the subject has been free of the disease for = 3 years
- •Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form
- •Patient with mental deficiency preventing proper understanding of the requirements of treatment
- •Adult under law-control
- •Contraindication to use rituximab or known sensitivity or allergy to murine products
- •Pregnant or lactating females
- •Concomitant disease requiring prolonged use of corticosteroids, or corticosteroids administration for lymphoma within 28 days before the first study drug administration
- •Male and female patients of childbearing potential who cannot or do not wish to use an effective method of contraception, during the study treatment and for 12 months thereafter
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