NCT00906841终止2 期
Phase II Study of Evaluation of Fractionated Radio-immunotherapy With 90Y-DOTA-hLL2 as a Consolidation Therapy After First Line of Chemotherapy in Patients Older Than 60 With Disseminated Diffuse Large B-cell Lymphoma
French Innovative Leukemia Organisation1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2007年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Event free survival (EFS)
研究概览
简要总结
Phase II, multi-centric, open-label, study.
Disseminated diffuse large B-cell lymphoma in patients older than 60: evaluation of fractionated radio-immunotherapy with 90Y-DOTA-hLL2 as a consolidation therapy after first line of chemotherapy.
详细描述
Initial treatment: 6 courses of CHOP-R 14 with evaluation of response before C4 (observation of no change or progression at this time will get the patient off study).
Consolidation : fractionated RIT (8 weeks after the end of R-CHOP: 2 injections of 15 mCi/m2 of 90Y-DOTA-hLL2 and hLL2 at day 1 and day 8).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 60 and < 80 years
- •Non eligible for stem cell transplantation
- •CD20 diffuse large B-cell lymphoma according to the WHO classification
- •Bulky stage I and II > ou =7 cm and stage III and IV
- •Performance status 0 - 2
- •Creatinine clearance >ou = 50 ml/min (Cockroft formula).
- •Serum bilirubin < ou =30 mmol/l
- •Leucocytes > ou =3 G/l, granulocytes > ou = 1,5 G/l, platelets >ou= 100 G/L.
- •HIV negative
- •Written informed consent
排除标准
- •Age < 60 years and > 80 years
- •Other types of lymphomas except CD20+ diffuse large B-cell lymphoma according to the WHO classification
- •Histologic transformation of low grade lymphoma (Involvement of the bone marrow by small B-cell lymphoma will not lead to exclusion of the patient)
- •Primary lymphoma of the central nervous system and transformed gastro intestinal MALT lymphoma
- •Meningeal involvement
- •Bone marrow involvement > 25% after R-CHOP
- •Aggressive post-transplantation lymphoma
- •Absence of CD20 expression on tumor cells
- •Non bulky stages I et II
- •HIV positive
- •Active Hepatitis B or C
- •Left ventricular ejection fraction < 50%.
- •Contra-indication to R-CHOP treatment
- •Previous or concurrent second malignancy except for adequately treated basal cell carcinoma of the skin, curatively treated in situ carcinoma of the cervix, curatively treated solid cancer, with no evidence of disease for at least 5 years
- •Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
- •Participation at the same time in another study in which investigational drugs are used
- •Absence of written informed consent
研究组 & 干预措施
90Y-DOTA-hLL2
Experimental
Fractionated RIT (8 weeks after the end of R-CHOP: 2 injections of 15 mCi/m2 of 90Y-DOTA-hLL2 and hLL2 at day 1 and day 8)
干预措施: 90Y-DOTA-hLL2 (Drug)
结局指标
主要结局
Event free survival (EFS)
时间窗: EFS post treatment (at 2 years)
次要结局
- Objective disease response (CR, CRu and PR), SD and disease progression(OS after treatment)
- Time to disease progression(Time interval from the date from initial of study treatment until the date on which disease progression is documented)
- Duration of response(Time interval from the date on which a response (CR, CRu and PR))
研究者
研究点 (1)
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