EUCTR2006-001433-17-IT进行中（未招募）不适用
A double-blind, randomized, two-dose-arm, parallel, international, multi-center trial of HuMax-CD20, a fully human monoclonal anti-CD20 antibody, in patients with Follicular Lymphoma who are refractory to rituximab in combination with chemotherapy - HuMax-CD20 in FL patients refractory to rituximab
GLAXO SMITH KLINE RESEARCH & DEVELOPMENT LTD0 个研究点目标入组 161 人开始时间: 2007年3月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 161
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
- •The trial population will be comprised of patient with a diagnosis of Follicular Lymphoma grade 1 - 2 refractory to rituximab in combination with chemotherapy or to rituximab given as maintenance treatment. Follicular Lymphoma grade 1 - 2 is defined according to WHO guidelines (3) and is verified to be CD20+ positive from excisional lymph node biopsy. Refractory to rituximab in combination with chemotherapy (e.g. R-F, R-CVP, R-CHOP, R-FM, R-FCM), or to rituximab given as maintenance treatment, is defined as: 1. failure to achieve at least PR to rituximab in combination with chemotherapy; or, 2. disease progression while on rituximab (either in combination with chemotherapy or during rituximab maintenance treatment); or, 3. disease progression in responders within 6 months of the last dose of rituximab (either in combination with chemotherapy or after rituximab maintenance treatment schedule) The patients should be `?¥ 18 years of age and have given informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •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
- •The most important exclusion criteria consist of allogenic stem cell transplantation at any time, autologous stem cell transplantation within 6 months prior to Visit 1, more than 1 previous radio immunotherapy, anticancer therapy or corticosteroid therapy within 4 weeks prior to Visit 1 or known or suspected transformation of the follicular lymphoma to aggressive lymphoma unless new biopsy confirms FL.
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A double-blind, randomized, two-dose-arm, parallel group, international, multi-center trial of HuMax-CD20, a fully human monoclonal anti-CD20 antibody, in patients with Follicular Lymphoma who are refractory to rituximab as monotherapy or in combination with chemotherapy - HuMax-CD20 in FL patients refractory to rituximabon-Hodgkin Follicular LymphomaClassification code 10003899EUCTR2006-001433-17-DKGenmab A/S162
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A double-blind, randomized, two-dose-arm, parallel group, international, multi-center trial of HuMax-CD20, a fully human monoclonal anti-CD20 antibody, in patients with Follicular Lymphoma who are refractory to rituximab as monotherapy or in combination with chemotherapy - HuMax-CD20 in FL patients refractory to rituximabEUCTR2006-001433-17-DEGlaxo SmithKline Research and Development Limited120
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A double-blind, randomized, two-dose-arm, parallel group, international, multi-center trial of HuMax-CD20, a fully human monoclonal anti-CD20 antibody, in patients with Follicular Lymphoma who are refractory to rituximab in combination with chemotherapy - HuMax-CD20 in FL patients refractory to rituximabon-Hodgkin Follicular LymphomaMedDRA version: 8.1Level: PTClassification code 10003899Term: B-cell lymphomaEUCTR2006-001433-17-NLGenmab A/S162
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