CTIS2022-500031-37-00招募中1 期
RADAR: A randomised phase III trial with a PET response adapted design comparing ABVD +/- ISRT with A2VD +/- ISRT in patients with previously untreated stage IA/IIA Hodgkin lymphoma - ?? UCL/15/0105
niversity College London0 个研究点目标入组 642 人开始时间: 2023年3月24日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 642
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
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Males and females age 16-69 years (inclusive). For EORTC centres, Age = 18 up to 69 years (see GSA document), Adequate bone marrow function with neutrophils =1.0x10exp9/l and platelets =100 x10exp9/l, Haemoglobin = 8g/dl, Willing and able to comply with the requirements of the protocol, including contraceptive advice, where applicable, Written informed consent, Histologically confirmed classical Hodgkin lymphoma, Stage I or II supradiaphragmatic disease with no mediastinal bulk disease (defined as greater than a third of the transthoracic diameter at any level of thoracic vertebrae as determined by CT) or B symptoms. Bulky disease at other sites is acceptable. Extranodal disease (single extranodal site (stage I) or contiguous extranodal extension (stage II)) is acceptable., ECOG performance status 0-2, No previous treatment for Hodgkin lymphoma, Fit to receive anthracycline based chemotherapy (patients with a history of ischaemic heart disease or hypertension should have a left ventricular ejection fraction of =50%), Creatinine clearance (measured or calculated) >40 ml/min, Total bilirubin < 1.5 x upper limit of normal, unless attributable to disease or known Gilbert’s syndrome, ALT or AST < 2 x the upper limit of normal
排除标准
- •Previous treatment for Hodgkin lymphoma, excluding short courses of oral corticosteroids at a dose of up to 100mg prednisolone (or equivalent) for up to 7 days, Symptomatic neurologic disease compromising normal activities of daily living or requiring medications, Infection with HIV, hepatitis C or active hepatitis B infection (surface antigen or DNA positive), Any active systemic viral, bacterial, or fungal infection requiring systemic antibiotics, antivirals or antifungals within 2 weeks prior to first study drug dose, Receiving or recently treated with any other investigational agent (within 4 weeks of study entry), Pregnant or breastfeeding women, Known hypersensitivity to recombinant proteins, murine proteins, or to any excipient contained in the drug formulation of brentuximab vedotin or any component of ABVD, Known history of any cardiovascular or respiratory conditions that would preclude anthracycline or bleomycin administration, Other significant medical or psychiatric co-morbidity that in the opinion of the investigator would make administration of ABVD or A2VD hazardous, Infradiaphragmatic disease, Nodular lymphocyte predominant Hodgkin lymphoma, Absence of FDG-avid lymphoma lesions on baseline PET scan, Age 70 years or over, or 17 years and under, Other cancer diagnosed within the last 5 years apart from completely excised carcinoma in situ of any type and basal or squamous cell carcinoma of the skin, Recurrent or persistent other cancer within last 5 years irrespective of date of initial diagnosis, Pre-existing sensory or motor peripheral neuropathy from any cause, grade =1, History of or current progressive multi-focal leukoencephalopathy or other chronic condition of the brain
研究者
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