NCT02303119已完成3 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)
The Lymphoma Academic Research Organisation50 个研究点 分布在 1 个国家目标入组 221 人开始时间: 2015年2月2日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 221
- 试验地点
- 50
- 主要终点
- Progression Free Survival (PFS)
研究概览
简要总结
Patient will receive either one infusion of rituximab IV and seven administrations of rituximab SC (experimental arm) or four infusions of rituximab IV (standard arm).
The hypothesis is that the use of rituximab by sub cutaneous route and the scheme of administration could:
- optimize rituximab exposure leading to improve response rate
- increase adaptative response and then improve long-term control disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 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 tumor 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 β2 microglobulin < ULN within 28 days before the randomization
- •Have signed an informed consent
- •Must be covered by a social security system
排除标准
- •Grade 3b follicular lymphoma
- •Ann Arbor Stage I
- •Seropositive for or active viral infection with hepatitis B virus (HBV) 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 informed consent and the requirements of treatment.
- •Adult under law-control
- •Adult under tutelage
- •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.
研究组 & 干预措施
Am A : Rituximab IV
Active Comparator
4 infusions of intravenous rituximab (375mg/m²) at Day 1, Day 8, Day 15 and D22
干预措施: Rituximab IV (Drug)
Arm B: Rituximab SC
Experimental
1 infusion of intravenous rituximab (375mg/m²) at Day 1, and 7 administrations of sub-cutaneous rituximab (1400mg) at Day 8, Day15, Day 22, Month 3, Month 5, Month 7 and Month 9.
干预措施: Rituximab IV (Drug)
Arm B: Rituximab SC
Experimental
1 infusion of intravenous rituximab (375mg/m²) at Day 1, and 7 administrations of sub-cutaneous rituximab (1400mg) at Day 8, Day15, Day 22, Month 3, Month 5, Month 7 and Month 9.
干预措施: Rituximab SC (Drug)
Arm C : Rituximab SC first cycle
Experimental
8 administrations of sub-cutaneous rituximab (1400mg) at Day 8, Day15, Day 22, Month 3, Month 5, Month 7 and Month 9.
干预措施: Rituximab SC (Drug)
结局指标
主要结局
Progression Free Survival (PFS)
时间窗: 5.5 years
Time from randomization into the study to the first observation of documented disease progression or death due to any cause. If a subject has not progressed or died, PFS will be censored at the time of last visit with adequate assessment
次要结局
- Overall Survival (OS)(5.5 years)
- Best Response Rate during the study(M3 and M12)
- Time to Next Anti-Lymphoma Treatment (TTNLT)(5.5 years)
- Molecular Response(M3 and M12)
- Response Rates(M3 and M12)
研究者
研究点 (50)
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