EUCTR2013-003253-21-DE进行中（未招募）1 期
B-NHL 2013 - Treatment protocol of the NHL-BFM and the NOPHO study groups for mature aggressive B-cell lymphoma and leukemia in children and adolescents - B-NHL 2013
niversitätsklinikum Münster0 个研究点目标入组 650 人开始时间: 2017年1月3日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 650
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
- •newly diagnosed, histological or cytological and immunological proven aggressive mature B-cell Non-Hodgkin lymphoma including Burkitt lymphoma (BL), Burkitt leukemia (B-AL), diffuse large B-cell lymphoma (DLBCL), or mature B-cell NHL not further classified according to current WHO classification. For rare subtypes (e.g. primary mediastinal large B-NHL, PMLBL double hit lymphoma or high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements), consultation of the study center is recommended.
- •availability of slides/blocks for reference pathology and international pathology panel (except in cases with immunological and cytomorphological assurance of diagnosis)
- •age at diagnosis < 18 years
- •diagnostics and treatment in one of the participating centers of the trial
- •no previous chemotherapy, no previous lymphoma-directed treatment. No application of steroids for more than two days during the last month
- •adequate hepatic, renal and cardiac function, except if alteration is due to lymphoma Infiltration. Please contact the study center in case of unclear cases.
- •signed informed consent of patient and or parents/guardians for treatment according to the protocol, participation and transfer of data
- •follow-up of at least two years after initial diagnosis is expected
- •certificate of vaccination against hepatitis B or negative serology, defined as
- •- evidence of immunization with HBs-antigen negative, anti-HBs positive and anti-HBc negative or
- •- negative hepatitis B serology with HBs-antigen negative, anti-HBs and anti-HBc negative
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 650
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •patients with insufficient work up not allowing a correct stratification into the risk groups
- •B-cell neoplasia as second malignancy
- •any other medical, psychiatric, or social condition prohibiting treatment according to the protocol (e.g. previous malignancy, prior organ transplant, HIV infection or AIDS or severe immunodeficiency, etc.)
- •participation within a different trial for treatment of B-cell malignancies and/or concurrent treatment within any other clinical trial. Exceptions to this are the NHL-BFM Registry 2012 and trials with different endpoints, involving aspects of supportive treatment which can run parallel to B-NHL 2013 without influencing the outcome of this trial e.g. trials on antiemetics, antibiotics, strategies for psychosocial support etc.
- •overt hepatitis B or history of hepatitis B
- •hypersensitivity to rituximab or to murine proteins, or to any of the other excipients of the Investigational Medicinal Product or to ingredients of other IMPs
- •lack of CD20 expression of the lymphoma cells
- •pregnancy and lactation
研究者
相似试验
进行中（未招募）
1 期
oEUCTR2013-003253-21-NOniversitätsklinikum Münster650
进行中（未招募）
1 期
omature aggressive B-cell lymphoma and leukemia in children and adolescentsMedDRA version: 20.0Level: HLGTClassification code 10025320Term: Lymphomas non-Hodgkin's B-cellSystem Organ Class: 10005329 - Blood and lymphatic system disordersEUCTR2013-003253-21-SEniversitätsklinikum Münster650
进行中（未招募）
1 期
oEUCTR2013-003253-21-DKniversitätsklinikum Münster650
招募中
1 期
B-NHL 2013 - Treatment protocol of the NHL-BFM and the NOPHO study groups for mature aggressive B-cell lymphoma and leukemia in children and adolescentsmature aggressive B-cell lymphoma and leukemia in children and adolescentsMedDRA version: 20.0Level: SOCClassification code: 10005329Term: Blood and lymphatic system disorders Class: 3MedDRA version: 20.0Level: HLGTClassification code: 10025320Term: Lymphomas non-Hodgkin's B-cell Class: 10029104CTIS2023-505509-18-00niversitaetsklinikum Muenster AöR650
进行中（未招募）
1 期
omature aggressive B-cell lymphoma and leukemia in children and adolescentsMedDRA version: 20.0Level: HLGTClassification code 10025320Term: Lymphomas non-Hodgkin's B-cellSystem Organ Class: 10005329 - Blood and lymphatic system disordersEUCTR2013-003253-21-FIniversitätsklinikum Münster650