NL-OMON20455
招募中
不适用
Randomized phase III study of Rituximab with intensified CHOP chemotherapy (R-iCHOP-14) versus Rituximab with High-DoseSequential Therapy and Autologous Stem Cell Transplantation (R-HDT+ASCT) in Adult Patients (18-65 yrs) with Stage II-IVHigh-intermediate or High Risk Diffuse Large B-Cell Lymphoma.
未提供0 个研究点目标入组 250 人待定
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- 未指定
- 发起方
- 未提供
- 入组人数
- 250
- 状态
- 招募中
- 最后更新
- 2年前
概览
简要总结
/A
研究者
入排标准
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 \<\= 2;
- •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,
- •Appendix F) 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;
结局指标
主要结局
未指定
相似试验
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 DLBCISRCTN46136861Dutch Haemato-oncology Association (Stichting Hemato-Oncologie Volwassenen Nederland) (HOVON)250
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 macroglobulinaemiaTherapeutic area: Diseases [C] - Cancer [C04]EUCTR2019-001261-33-GBniversity College London148
已完成
3 期
A Multicentre, Randomized Phase III Study of Rituximab as Maintenance Treatment Versus Observation in Patients With Aggressive B-cell Lymphoma: NHL-13Diffuse Large B-Cell Lymphoma (DLBCL)Follicular NHL Grade 3bNCT00400478Arbeitsgemeinschaft medikamentoese Tumortherapie683
已完成
2 期
A phase II study of the combination of Rituximab, Mitoxantrone, Etoposide, and Prednisolone for relapsed elderly patients with diffuse large B-cell lymphoma (R-MEP07)Diffuse large B-cell lymphomaJPRN-UMIN000001050Clinical Hematology Study Group of National Hospital Organization (CHSG-NHO)40
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 proceduresTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]EUCTR2009-017066-23-GBGuys and St Thomas Foundation Trust