EUCTR2006-005174-42-DK进行中（未招募）1 期
Randomized phase III study on the effect of early intensification of rituximab in combination with 2-weekly CHOP chemotherapy followed by rituximab maintenance in elderly patients (66-80 years) with diffuse large B-cell lymphoma - HOVON 84 NH
HOVON Foundation0 个研究点目标入组 550 人开始时间: 2008年8月1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
- 550
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
- •For first randomization:
- •Patients with a confirmed histologic diagnosis of diffuse large B-cell lymphoma (DLBCL) based upon a representative histology specimen according to the WHO classification (see appendix A)
- •DLBCL must be CD20 positive
- •Ann Arbor stages II-IV (see appendix C)
- •Age = 66 and ? 80 years
- •WHO performance status 0 – 2 (see appendix E)
- •Written informed consent
- •For second randomization:
- •Patients achieving a CR (or FDG-PET negative PR/CRu) after 8 cycles of R-CHOP14 will be randomized to maintenance treatment with rituximab or no further treatment.
- •Patients in complete remission or FDG-PET negative partial remission/unconfirmed complete remission at least 4 weeks after the last of 8 cycles of R-CHOP14
- •Time interval since last cycle of R-CHOP14 between 4 and 8 weeks
- •No rituximab-related adverse event necessitating stopping of rituximab administration
- •No active infection
- •Written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •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
- •Intolerance of exogenous protein administration
- •Severe cardiac dysfunction (NYHA classification III-IV, see appendix F) or LVEF < 45%
- •Congestive heart failure or symptomatic coronary artery disease or cardiac arrhythmias not well controlled with medication. Myocardial infarction during the last 6 months
- •Severe pulmonary dysfunction (vital capacity or diffusion capacity < 50% of predicted value) unless clearly related to NHL involvement
- •Patients with uncontrolled asthma or allergy, requiring systemic steroid treatment
- •Significant hepatic dysfunction (total bilirubin ? 30?mol/l or transaminases = 2.5 x upper normal limit), unless related to NHL
- •Significant renal dysfunction (serum creatinine = 150 umol/l or clearance = 60 ml/min), unless related to NHL
- •Clinical signs of severe cerebral dysfunction
- •Suspected or documented Central Nervous System involvement by NHL
- •Patients with a history of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant and adversely affecting compliance to study drugs
- •Testicular DLBCL
- •Primary mediastinal B cell lymphoma
- •Transformed indolent lymphoma
- •(EBV) post-transplant lymphoproliferative disorder
- •Secondary lymphoma after previous chemotherapy or radiotherapy
- •Major surgery, other than diagnostic surgery, within the last 4 weeks
- •Patients with active uncontrolled infections
- •Patients known to be HIV-positive
- •Active chronic hepatitis B or C infection
- •Serious underlying medical conditions, which could impair the ability of the patient to participate in the trial (e.g. ongoing infection, uncontrolled diabetes mellitus, gastric ulcers, active autoimmune disease)
- •Life expectancy < 6 months
- •Prior treatment with chemotherapy, radiotherapy or immunotherapy for this lymphoma, except a short course of prednisone (< 1 week) and/or cyclophosphamide (< 1 week and not in excess of 900 mg/m2 cumulative) or local radiotherapy in order to control life threatening tumor related symptoms
- •History of active cancer during the past 5 years, except basal carcinoma of the skin or stage 0 cervical carcinoma
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