ISRCTN82286322已完成3 期
Randomised phase III study on the effect of early intensification of rituximab in combination with two-weekly cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) chemotherapy followed by rituximab maintenance in elderly patients (66 to 80 years) with diffuse large B-cell lymphoma
Dutch Haemato-Oncology Association (Stichting Hemato-Oncologie Volwassenen Nederland) (HOVON) (The Netherlands) - Data Centre0 个研究点目标入组 600 人开始时间: 2007年8月23日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 600
研究概览
简要总结
2020 Results article in https://pubmed.ncbi.nlm.nih.gov/32730183/ (added 07/10/2021)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Patients with a confirmed histological diagnosis of Diffuse Large B-Cell Lymphoma (DLBCL) based upon a representative histology specimen according to the World Health Organisation (WHO) classification
- •2. DLBCL must be CD20 positive
- •3. Ann Arbor stages II - IV
- •4. Greater than or equal to 66 and less than or equal to 80 years
- •5. Age WHO performance status 0 to 2
- •6. Written informed consent
排除标准
- •1. Intolerance of exogenous protein administration
- •2. Severe cardiac dysfunction (New York Heart Association [NYHA] classification III - IV or Left Ventricular Ejection Fraction [LVEF] less than 45%). Congestive heart failure or symptomatic coronary artery disease or cardiac arrhythmias not well controlled with medication. Myocardial infarction during the last six months
- •3. Severe pulmonary dysfunction (vital capacity or diffusion capacity less than 50% of predicted value) unless clearly related to Non-Hodgkin lymphoma (NHL) involvement
- •4. Patients with uncontrolled asthma or allergy, requiring systemic steroid treatment
- •5. Significant hepatic dysfunction (total bilirubin greater than or equal to 30mmol/l or transaminases greater than or equal to 2.5 x upper normal limit), unless related to NHL
- •6. Significant renal dysfunction (serum creatinine greater than or equal to 150 umol/l or clearance less than or equal to 60 ml/min), unless related to NHL
- •7. Clinical signs of severe cerebral dysfunction
- •8. Suspected or documented central nervous system involvement by NHL
- •9. 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
- •10. Testicular DLBCL
- •11. Primary mediastinal B cell lymphoma
- •12. Transformed indolent lymphoma
- •13. Epstein Barr Virus (EBV) lymphoproliferative disorder
- •14. Secondary lymphoma after previous chemotherapy or radiotherapy
- •15. Major surgery, other than diagnostic surgery, within the last four weeks
- •16. Patients with active uncontrolled infections
- •17. Patients known to be Human Immunodeficiency Virus (HIV)-positive
- •18. Active chronic hepatitis B or C infection
- •19. 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)
- •20. Life expectancy less than six months
- •21. Prior treatment with chemotherapy, radiotherapy or immunotherapy for this lymphoma, except a short course of prednisone (less than one week) and/or cyclophosphamide (less than one week and not in excess of 900 mg/m^2 cumulative) or local radiotherapy in order to control life threatening tumour related symptoms
- •22. History of active cancer during the past five years, except basal carcinoma of the skin or stage 0 cervical carcinoma
研究者
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