ISRCTN46136861已完成不适用
Randomized phase III study of Rituximab with intensified CHOP chemotherapy versus Rituximab with High-Dose Sequential Therapy and Autologous Stem Cell Transplantation in Adult Patients (18-65 years) with Stage II-IV High-intermediate or High Risk DLBC
Dutch Haemato-oncology Association (Stichting Hemato-Oncologie Volwassenen Nederland) (HOVON)0 个研究点目标入组 250 人开始时间: 2006年1月13日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 250
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
- 性别
- All
入选标准
- •1. Patients with a confirmed histologic diagnosis of DLBCL according to the WHO classification
- •2. Ann Arbor stage II-IV
- •3. High-intermediate or high risk NHL according to age-adjusted IPI score (aa IPI = 2-3)
- •4. DLBCL must be CD20 positive
- •5. Age 18-65 years inclusive
- •6. WHO performance status 7. Negative pregnancy test (if applicable)
- •8. Written informed consent
排除标准
- •1. Intolerance of exogenous protein administration
- •2. Severe cardiac dysfunction (NYHA classification II-IV) or LVEF <45%
- •3. Significant renal dysfunction (serum creatinine >/= 150 mumol/l), unless related to NHL
- •4. Significant hepatic dysfunction (total bilirubin >/= 30 mumol/l or
- •transaminases >/= 2.5 times normal level), unless related to NHL
- •5. Suspected or documented Central Nervous System involvement by NHL
- •6. Testicular DLBCL
- •7. Primary mediastinal B cell lymphoma
- •8. Patients known to be HIV-positive
- •9. Patients with active, uncontrolled infections
- •10. Patients with uncontrolled asthma or allergy, requiring steroid treatment
- •11. Patient is a lactating woman
- •12. Unwillingness or not capable to use effective means of contraconception (all men and pre-menopausal women)
- •13. 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
- •14. 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
招募中
不适用
Randomized phase III study of Rituximab with intensified CHOP chemotherapy vs. Rituximab with High-Dose Sequential Therapy and Autologous Stem Cell Transplantation in Adult Patients (18-65 yrs) with Stage II-IV High-intermediate or High Risk DLBCL.NL-OMON20455250
进行中(未招募)
不适用
A Randomized Controlled Trial of Rituximab Versus Steroids and Cyclophosphamide in the Treatment of Idiopathic Membranous Nephropathy (IMN)MN is an autoimmune disease, suggesting that the disease may be triggered by isotype specific autoantibodies directed against podocyte enzymes and podocyte receptors that are recognized as antigens. The key role of IgG antibodies formation in the pathogenesis of IMN suggests that B cell depletion may favourably impact the evolution of the glomerular disease and reduce proteinuria. We propose this study in order to test in a randomized controlled trial the hypMedDRA version: 14.1Level: PTClassification code 10018372Term: Glomerulonephritis membranousSystem Organ Class: 10038359 - Renal and urinary disordersEUCTR2011-006115-59-ITAZIENDA OSPEDALIERA SPEDALI CIVILI DI BRESCIA
进行中(未招募)
1 期
Study of Rituximab and Ibrutinib (RI) versus Dexamethasone, Rituximab and Cyclophosphamide (DRC) as initial therapy for Waldenström's macroglobulinaemiaWaldenström's macroglobulinaemiaEUCTR2019-001261-33-GBniversity College London148
进行中(未招募)
不适用
A randomized trial of Rituximab in induction therapy for living donor renal transplantation - Randomized trial of rituximab in renal transplantatioEnd stage renal diseaserenal function after renal transplantationMedDRA version: 17.0Level: PTClassification code 10038533Term: Renal transplantSystem Organ Class: 10042613 - Surgical and medical proceduresEUCTR2009-017066-23-GBGuys and St Thomas Foundation Trust
进行中(未招募)
1 期
A multi-centre pilot study of Rituximab in patients with active PsAPsoriatic ArthritisEUCTR2006-000844-17-SKVienna Medical University30
