EUCTR2004-001621-16-CZ进行中（未招募）1 期
An intergroup randomised trial of rituximab versus a watch and wait strategy in patients with advanced stage, asymptomatic, non-bulky fillicular lymphoma - Watch and Wait
niversity College London (UCL)0 个研究点目标入组 600 人开始时间: 2007年6月18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
- 600
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
- •- min. age 18 years, no upper limit
- •- follicular lymphoma grade 1,2 and 3a
- •- stage II, II and IV disease
- •- asymptomatic without B symptoms or severe pruritus
- •- blood count : Hb more than 10g/dl, Neuts more than 1,5 x 109/l, PLT more than 100 x 109/l and less than 5 x 109/l circulating tumour cells
- •- renal functions: creatinine less than 2 x UNL for reasons other than lymphoma
- •- normal liver function
- •- Low tumour burden defined as:
- •LDH within normal range
- •largest nodal or extranodal mass less than 7 cm
- •no more than 3 nodal sites with a diameter more than 3 cm
- •not significant serious effusions detectable clinically or on chest X-ray
- •spleen enlargement less than or equal to 16 cm by CT
- •- no other (non-lymphoma) immediately life-threatening disease
- •- must have the disease measurable in at least 2 dimension either clinically or radiologically
- •- entry within 3 months of biopsy with no prior therapy
- •- ECOG performance status 0-1
- •- no evidence of histological transformation
- •- no second malignancy unless treated with curative intent and patient has been disease-free for more than 2 years
- •- if second malignancy was basal cell carcinoma or squamouus cell carcinoma of the skin or carcinoma of the cervix, the patient need only be currently disease-free
- •- patient must be able to give informed consent
- •- no critical organ failure or organ compression
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- patients with known to be HIV positive
- •- patients with Hepatitis B infection (required tests - see appendix 3)
- •- pregnant or breastfeeding patients
- •- women of childbearing potential not willing to take adequate contraceptive precautions if randomised to rituximab containg arm
研究者
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