NL-OMON47490已完成3 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 patients with diffuse large B-cell lymphoma - HOVON 84 NH
HOVO0 个研究点目标入组 460 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 460
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
- 年龄范围
- 18 至 99（—）
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 18-65 years and
- •age-adjusted IPI 1-3 OR age 66-80 years and age-adjusted IPI 0-3 , - 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 6 (elderly) or 8 (young patients) 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 cycle of R-CHOP14 (including last
- •rituximab administration), - Time interval since last cycle of R-CHOP14
- •(including last rituximab administration) between 4 and 8 weeks, - No
- •rituximab-related adverse event necessitating stopping of rituximab
- •administration, - No active infection, - Written informed consent
排除标准
- •-Age 18-65 (inclusive) years and aa-IPI 0 (no risk factors), -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 >= 30mmol/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
研究者
相似试验
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 patients with diffuse large B-cell lymphomadiffuse large B-cell lymphomaEUCTR2006-005174-42-NLHOVON Foundation600
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 patients with diffuse large B-cell lymphomaMedDRA version: 21.0 Level: LLT Classification code 10012820 Term: Diffuse large B-cell lymphoma NOS System Organ Class: 100000004864diffuse large B-cell lymphomaEUCTR2006-005174-42-BEHOVON Foundation600
尚未招募
不适用
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 lymphomaDiffuse large B-cell lymphomaNL-OMON23148Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON) P/a HOVON Data CenterErasmus MC - Daniel den HoedPostbus 52013008 AE RotterdamTel: 010 4391568Fax: 010 4391028e-mail: hdc@erasmusmc.nl550
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 NHEUCTR2006-005174-42-DKHOVON Foundation550
已完成
不适用
A randomised controlled trial of effects of early life exposure to general anaesthesia on neurobehavioural outcomes in children with cystic fibrosis (CF)Early life exposure to general anaesthesiaNeurobehavioural outcomesAnaesthesiology - AnaestheticsHuman Genetics and Inherited Disorders - Cystic fibrosisCystic FibrosisACTRN12613000057785Department of Health and Ageing132