EUCTR2017-002544-32-GB进行中（未招募）1 期
A phase II study of nivolumab monotherapy in patients with relapsed/refractory Hodgkin lymphoma, fit for autologous stem cell transplant, who fail to reach complete metabolic remission after first or second line salvage therapy - ANIMATE
niversity College London0 个研究点目标入组 120 人开始时间: 2018年1月26日最近更新:
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
- 120
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
- •Inclusion criteria for registration
- •Age 16 or over
- •Primary refractory classical Hodgkin lymphoma or classical Hodgkin lymphoma in first relapse
- •About to receive, receiving or within 14 days of first 2 cycles of first or second line salvage therapy (4 cycles if receiving treatment with brentuximab vedotin)
- •Fit for autologous stem cell transplantation
- •Written informed consent
- •Willing to comply with the contraceptive requirements of the trial
- •Inclusion criteria – trial treatment
- •Has received 2 cycles of first line or second line salvage chemotherapy (4 cycles if being treated with brentuximab vedotin)
- •PET positive (Deauville score 4 or 5) after 2 cycles of first or second line salvage chemotherapy (4 cycles if being treated with brentuximab vedotin)
- •Fit for further salvage chemotherapy
- •ECOG performance status 0-1
- •Creatinine clearance >30ml/min calculated by Cockroft-Gault formula
- •Bilirubin <1.5 x ULN, ALT/AST <2.5 x ULN
- •Adequate bone marrow function (Hb >80g/l, Platelets >50 x 10^9/l, neutrophils >1.0 x 10^9/l
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 10
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 110
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Exclusion criteria for registration
- •Nodular lymphocyte predominant Hodgkin lymphoma
- •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 not requiring immunosuppressive therapy
- •Known history of hepatitis B or C infection
- •Known HIV infection
- •History of allergy (including severe/life threatening skin reaction) to monoclonal antibodies, anaphylaxis or uncontrolled allergy
- •Major surgery within 4 weeks prior to registration
- •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 (some exceptions apply – listed in trial protocol)
- •Exclusion criteria for trial treatment
- •Deauville score 1-3 after 2 cycles of first or second line salvage chemotherapy (4 cycles if being treated with brentuximab vedotin)
- •Positive serology for hepatitis B or C (unless due to vaccination)
- •Active infection requiring systemic therapy
- •Ongoing immunosuppressive therapy, apart from inhaled, intranasal, topical corticosteroids or systemic corticosteroids at low doses (=10mg prednisolone or equivalent per day).
- •Chemo- or radiotherapy or corticosteroids at a dose of more than 10mg/day prednisolone or equivalent within 14 days prior to response PET-CT. NOTE: corticosteroids can be used AFTER a positive PET-CT scan for symptomatic disease but must be weaned to a dose of prednisolone =10mg/day or less (or equivalent) at least 7 days prior to starting nivolumab.
- •Treatment with any investigational agent within 28 days prior to planned start of nivolumab
- •Ongoing grade 2-4 non-haematological toxicities related to prior Hodgkin lymphoma treatments, with the exception of alopecia and grade 2 fatigue
- •Pregnant or breastfeeding women
研究者
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