跳至主要内容
临床试验/CTRI/2015/05/005811
CTRI/2015/05/005811已完成3 期

A phase 3, randomized, double-blind study of PF-05280586 versus Rituximab for the first-line treatment of patients with CD20-positive, low tumor burden, follicular lymphoma - REFLECTIONS B328-06

Pfizer Limited0 个研究点目标入组 5 人开始时间: 待定最近更新:

试验速览

阶段
3 期
状态
已完成
入组人数
5

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

入选标准

  • Confirmed diagnosis of low tumor burden, CD20-positive follicular lymphoma (containing no elements of diffuse large B-cell lymphoma)
  • Ann Arbor Stage II, III, or IV
  • Eastern Cooperative Oncology Group (ECOG) status of 0 to 1
  • At least 1 measureable disease lesion of at least 1.5 cm in longest diameter

排除标准

  • Not a candidate for treatment with rituximab as a single-agent
  • Evidence of transformation to a high grade or diffuse large B-cell lymphoma
  • Central nervous system or meningeal involvement or cord compression by the lymphoma.
  • T-cell lymphoma.
  • Any prior treatment for lymphoma
  • Any prior treatment with rituximab
  • Active, uncontrolled infection

研究者

相似试验

进行中(未招募)
3 期
A Study of PF-05280014 [Trastuzumab-Pfizer] or Herceptin® [Trastuzumab-EU] Plus Paclitaxel in HER2 Positive First Line Metastatic Breast Cancer Treatment
CTRI/2014/07/004786Pfizer Limited
进行中(未招募)
1 期
A study comparing the efficacy, safety, pharmacokinetics and immunogenicity of PF-05280586 versus commercially available rituximab in treating patients with low tumor burden follicular lymphoma in the first-line treatment setting.low tumor burden follicular lymphomaMedDRA version: 17.1 Level: HLGT Classification code 10025320 Term: Lymphomas non-Hodgkin's B-cell System Organ Class: 10005329 - Blood and lymphatic system disorders
EUCTR2014-000132-41-HRPfizer Inc., 235 East 42nd Street, New York, NY 10017394
进行中(未招募)
1 期
A study comparing the efficacy, safety, pharmacokinetics and immunogenicity of PF-05280586 versus commercially available rituximab in treating patients with low tumor burden follicular lymphoma in the first-line treatment setting.low tumor burden follicular lymphomaMedDRA version: 17.1 Level: HLGT Classification code 10025320 Term: Lymphomas non-Hodgkin's B-cell System Organ Class: 10005329 - Blood and lymphatic system disorders
EUCTR2014-000132-41-GBPfizer Inc., 235 East 42nd Street, New York, NY 10017394
进行中(未招募)
1 期
A study comparing the efficacy, safety, pharmacokinetics and immunogenicity of PF-05280586 versus commercially available rituximab in treating patients with low tumor burden follicular lymphoma in the first-line treatment setting.low tumor burden follicular lymphomaMedDRA version: 20.0 Level: HLGT Classification code 10025320 Term: Lymphomas non-Hodgkin's B-cell System Organ Class: 10005329 - Blood and lymphatic system disorders
EUCTR2014-000132-41-PTPfizer Inc., 235 East 42nd Street, New York, NY 10017394
进行中(未招募)
1 期
A study comparing the efficacy, safety, pharmacokinetics and immunogenicity of PF-05280586 versus commercially available rituximab in treating patients with low tumor burden follicular lymphoma in the first-line treatment setting.
EUCTR2014-000132-41-ESPfizer Inc., 235 East 42nd Street, New York, NY 10017394