EUCTR2007-006064-30-SE进行中（未招募）1 期
A randomised phase III trial to assess response adapted therapy using FDG-PET imaging in patients with newly diagnosed, advanced Hodgkin Lymphoma - RATH
niversity College London0 个研究点目标入组 1,200 人开始时间: 2009年4月14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
- 1,200
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
- •1. Histologically confirmed classical Hodgkin lymphoma according to the current WHO Classification. All histology will be reviewed centrally.
- •2. Stage IIB, III or IV, or stage IIA with adverse features, defined as:
- •- bulk mediastinal disease, defined as maximal diameter of mass >0.33 of the internal thoracic diameter at D5/6 on PA chest X-ray, or outside the mediastinum, lymph node or lymph node mass greater than 10cm in diameter
- •- >=2 extranodal sites of disease
- •- other poor risk features as a result of which it is considered necessary to treat with full course combination chemotherapy
- •3. No previous treatment for Hodgkin Lymphoma
- •4. Adequate performance status (WHO 0-3); bone marrow function; renal and liver function.
- •5. Patients with a significant history of ischaemic heart disease or hypertension must have a left ventricular ejection fraction (LVEF) greater than or equal to 50%.
- •6. Written, informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 900
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 300
排除标准
- •1. Poorly-controlled diabetes mellitus, or other serious medical conditions
- •2. Current pregnancy or lactation
- •3. Central nervous system or meningeal involvement by the lymphoma. Neurological contra-indication to chemotherapy (e.g. pre-existing neuropathy).
- •4. Significant lung disease with abnormal lung function tests (DLCO >25% below predicted) not attributable to lymphoma
- •5. Known serology for HIV, Hepatitis B or Hepatitis C (but no requirement for routine testing in the absence of risk factors).
研究者
相似试验
进行中（未招募）
不适用
Patients with untreated advanced Hodgkin Lymphoma will be randomised depending on their response to initial treatment of 2 cycles of ABVD using a PET scaMedical condition under investigation is Hodgkin Lymphoma, which is a cancer of the lymphatic system. It is usually treated with either chemotherapy or radiotherapy or a combination of both.MedDRA version: 18.1Level: LLTClassification code 10020328Term: Hodgkin's lymphomaSystem Organ Class: 100000004864EUCTR2007-006064-30-GBniversity College London1,200
进行中（未招募）
1 期
The trial aims to test whether PET-CT scanning assessing the initial response to chemotherapy can be used to guide subsequent treatmentMedical condition under investigation is Hodgkin Lymphoma, which is a cancer of the lymphatic system. It is usually treated with either chemotherapy or radiotherapy or a combination of both.MedDRA version: 20.0Level: LLTClassification code 10020328Term: Hodgkin's lymphomaSystem Organ Class: 100000004864EUCTR2007-006064-30-DKniversity College London1,200
已完成
3 期
A randomised Phase III Trial to assess response adapted therapy using 2-[F-18]fluoro-2-deoxy-d-glucose positron emission tomography (FDG-PET) imaging in patients with newly diagnosed, advanced Hodgkin LymphomaHodgkin LymphomaCancer - Hodgkin'sACTRN12610000927022niversity College1,203
进行中（未招募）
不适用
A Randomised Phase III Trial to assess response adapted therapy using FDG-PET imaging in patients with newly diagnosed, advanced Hodgkin Lymphoma - RATHL TrialAdvanced Hodgkin LymphomaMedDRA version: 9.1Level: LLTClassification code 10020328Term: Hodgkin's lymphomaEUCTR2007-006064-30-IEniversity College London1,200
进行中（未招募）
1 期
A randomised Phase III trial to evaluate the efficacy of chemoimmunotherapy with the monoclonal antibody Campath-1H (Alemtuzumab) given in combination with 2-weekly CHOP (Cyclophosphamide, Doxorubicin, Vincristine and Prednisone) versus 2-weekly CHOP alone in elderly patients with previously untreated systemic T- cell Lymphoma Short Title: A-CHOP-14 (elderly) - A-CHOP-14 (elderly)Primary therapy of patients with Alk-negative T-NHL in patients aged 61 - 80 yearsICD classification codes : ICD-O 9702/39717/39716/39708/39705/39714/3MedDRA version: 9.1Level: LLTClassification code 10002464Term: Angiomimmunoblastic (AILD, LgX (Kiel Classification)MedDRA version: 9.1Level: LLTClassification code 10025632Term: Malignant lymphomaEUCTR2007-000821-23-BEniversity Medicine Goettingen274