Very early FDG-PET-response adapted targeted therapy for advanced Hodgkin lymphoma: a single-arm phase II study - COBRA

European Organisation for Research and Treatment of Cancer (EORTC)0 个研究点目标入组 150 人开始时间: 2018年11月21日最近更新: 2019年4月30日

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: 150

研究概览入排标准研究者记录与标识符相似试验

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

入选标准

•Previously untreated, histologically proven classical Hodgkin lymphoma;
•Staged by PET with diagnostic-quality CT (i.v. contrast).
•- Clinical stages according to Lugano 2014 and based on FDG/PET CT:Stage IIB with large mediastinal mass > 1/3 max transverse diameter thorax and/or extranodal lesion(s) (GHSG)
•- Stage III - IV
•Participation in translational research is mandatory and therefore patient must consent for it. The following material must be available:
•- Archival tumor tissue available (15 blank formalin fixed paraffin embedded tissue samples mounted on APES slides or a tissue block);
•- To allow sequential sampling of blood during the course of the trial.
•Age =18 and =60
•WHO performance status 0-2
•Patient demonstrates adequate organ function as defined in the protocol.
•Women of child bearing potential (WOCBP) must have a negative serum pregnancy test within 72 hours prior to the first dose of study treatment.
•Patients of childbearing / reproductive potential should use two birth control methods, as defined by the investigator, from the time of signing the informed consent form , and throughout the entire study and for 6 months after the last dose of treatment.
•Female subjects who are breast feeding should discontinue nursing prior to the first dose of study treatment and until 6 months after the last study treatment.
•Absence of any medical, psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
•Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations.
•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 150
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

排除标准

•Known cerebral or meningeal disease (HL or any other etiology), including signs or symptoms of Progressive Multifocal Leukoencenphalopathy
•Symptomatic neurologic disease compromising normal activities of daily living or requiring medications
•Sensory or motor peripheral neuropathy greater than or equal to grade 2 according to CTCAE version 5.0
•Any of the following cardiovascular conditions or values:
•- within 6 months before registration:
•A left-ventricular ejection fraction <50%
•New York Heart Association (NYHA) Class III or IV heart failure (see Appendix D).
•Evidence of current uncontrolled cardiovascular conditions, including cardiac arrhythmias, congestive heart failure (CHF), angina, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities
•symptomatic coronary heart disease (stable angina pectoris is allowed)
•severe uncontrolled hypertension defined as blood pressure (BP) >150/100 mmHg despite optimal antihypertensive treatment
•- within 2 years before registration:
•Myocardial infarction
•Patients with poorly controlled diabetes mellitus (HbA1c > 7.5 % or a fasting blood sugar > 200 mg/dL).
•Any active systemic viral, bacterial, or fungal infection requiring systemic antibiotics within 2 weeks prior to registration.
•Known HIV infection, chronic active hepatitis C, HBV positivity (HBsAg + patients; HBsAg -/HBcAb+/HBV DNA+ patients).
•Note: HBsAg-/HBV DNA – patients are eligible; patients who are seropositive due to vaccination are eligible
•Concomitant or previous malignancies within the past 5 years with the exception of adequately treated carcinoma in situ of the cervix , nonmelanoma skin cancer.
•Previous treatment with anti CD30 antibodies
•Known hypersensitivity to any excipient contained in Brentuximab Vedotin formulation and other study drugs. Refer to Summary Product Characteristics for list of excipients.
•Concurrent anti-cancer treatment or use of any investigational agent(s)

研究者

发起方

European Organisation for Research and Treatment of Cancer (EORTC)

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NL-OMON50149European Organisation for Research in Treatment of Cancer (EORTC)38