EUCTR2015-000832-13-GB进行中（未招募）1 期
Randomised, open label study of rituximab/ibrutinib vs rituximab/chemotherapy in older patients with untreated mantle cell lymphoma - ENRICH Ibrutinib for untreated mantle cell lymphoma
niversity Hospitals Plymouth NHS Trust0 个研究点目标入组 400 人开始时间: 2017年1月17日最近更新:
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
- 400
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
- •Male/female patients 60 years and over
- •Pathologically confirmed MCL, with documentation of monoclonal B cells that have a chromosome translocation t(11:14)(q13;q32) and/or overexpress cyclin D1
- •Stage II-IV disease, measurable (>1.5cm) by imaging and requiring treatment in the opinion of the treating clinician
- •No previous treatment for MCL (other than localised radiotherapy or 7 day pulse of steroids for symptom control)
- •Performance status ECOG 0-2
- •Absolute neutrophil count >1.0x10*9/L or platelets >100x10*9 /L independent of growth factor support or unless related to lymphoma
- •AST and/or ALT <3xULN
- •Total bilirubin =1.5xULN unless bilirubin rise is due to Gilbert’s syndrome or of non-hepatic origin
- •Calculated creatinine clearance >30mL/min
- •Cardiac function sufficient to tolerate either Rituximab-CHOP or Rituximab-Bendamustine chemotherapy
- •Able to give voluntary written 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 80
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 320
排除标准
- •Patients considered fit enough to undergo autologous or allogeneic stem cell transplant as treatment for MCL
- •Known serological positivity for HBV, HCV, HIV
- •Major surgery within two weeks prior to Day 1 of Cycle 1
- •Diagnosed with or treated for any other malignancy than MCL within 2 years prior to Day 1 of Cycle 1 (except BCC, SCC or any in situ malignancy)
- •Active systemic infection requiring treatment
- •Male subjects with female partners of childbearing potential who are unwilling to use appropriate contraception methods whilst on study treatment
- •Women who are pregnant or breastfeeding
- •Serious medical or psychiatric illness likely to interfere with participation in this clinical study
- •Concurrent treatment with another investigational agent
研究者
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