EUCTR2018-002227-42-GB进行中（未招募）1 期
Avelumab in the frontline treatment of advanced classical Hodgkin lymphoma - a window study - AVENuE
niversity College London0 个研究点目标入组 47 人开始时间: 2018年11月5日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 47
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
- •Aged 16-60 (inclusive)
- •Previously untreated classical Hodgkin lymphoma
- •High risk stage II (defined as stage IIB, presence of bulky disease (but see exclusions), 3 or more sites of disease), stage III or IV as assessed by FDG-PET/CT
- •ECOG performance status 0-1
- •Adequate bone marrow function (Hb >80g/l, Platelets >75 x 109/l, neutrophils >1.0 x 109/l)
- •Adequate liver function tests (ALT/AST <2.5 x ULN, total serum bilirubin level <1.5 x ULN)
- •Creatinine clearance >50ml/min calculated by Cockroft-Gault formula
- •Written informed consent
- •Willing to comply with the contraceptive requirements of the trial
- •Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 1
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 46
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Nodular lymphocyte predominant Hodgkin lymphoma
- •Compressive symptoms due to disease (which may or may not be bulky). If there is evidence of compression of vital structures radiologically but the patient is asymptomatic, the case must be discussed with the TMG.
- •Requirement for urgent treatment due to life-threatening complications of the disease
- •Women who are pregnant or breastfeeding
- •History of colitis, inflammatory bowel disease or pneumonitis
- •Patients with autoimmune disorders excluding patients with vitiligo, diabetes mellitus type 1, hypo- and hyperthyroidism, coeliac disease not requiring immunosuppressive therapy
- •Immunosuppressive therapy within the last 2 months, apart from inhaled, intranasal, topical corticosteroids or systemic corticosteroids at low doses (=10mg prednisolone per day or equivalent - see steroid exception below)
- •Prior history of solid organ or allogeneic haematopoietic stem cell transplant
- •Positive serology for hepatitis B or C (unless due to vaccination)
- •Known HIV infection
- •Administration of a live vaccine within 30 days prior to study entry
- •History of allergy to monoclonal antibodies, anaphylaxis or uncontrolled allergy
- •Chemo- or radiotherapy within 15 days of registration. Corticosteroids permitted for disease control but must be weaned down to =10mg prednisolone per day or equivalent at least 7 days prior to starting avelumab – steroids may only be started for disease control after the baseline PET-CT
- •Persisting toxicity (of >grade 1) related to prior therapy, however, alopecia, sensory neuropathy Grade <2, or other grade <2 not constituting a safety risk based on investigator’s judgement are acceptable
- •Major surgery within 4 weeks prior to registration
- •Active infection requiring systemic therapy
- •Myocardial infarction, unstable angina, coronary artery bypass graft, cerebrovascular accident or transient ischaemic attack within the past 6 months
- •Non-haematological malignancy within the past 3 years
- •Previously treated haematological malignancy
- •Any uncontrolled medical condition which can impair delivery of planned immunochemotherapy
- •Patient not deemed suitable for ABVD/AVD/escalated-BEACOPP/BEACOPP-14
研究者
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