EORTC-1537-LYMG: Very early FDG-PET-response adapted targeted therapy for advanced Hodgkin lymphoma: a single-arm phase II study

European Organisation For Research And Treatment Of Cancer16 个研究点分布在 7 个国家目标入组 7 人开始时间: 2024年10月16日最近更新: 2024年11月8日

试验速览

阶段: 2 期
状态: 招募中
发起方
入组人数: 7
试验地点: 16
主要终点: Modified progression-free survival rate at 2 years after start of treatment (2yr-mPFS for each patient). The following are considered events for the primary endpoint: progression/relapse; start of new treatment for cHL when not in CR after completing protocol treatment; death from any cause.

研究概览入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The main objective of this trial is to assess whether treatment adaptation based on a very early FDG-PET/CT results in improved efficacy while minimizing treatment toxicity in advanced stage HL patients treated with BV-containing regimens, BrAVD and BrECADD. This will be primarily assessed by modified progression-free survival.

入排标准

年龄范围: 18 years 至 64 years（18-64 Years）
接受健康志愿者: 否

入选标准

•Previously untreated, histologically proven classical Hodgkin lymphoma
•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
•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 to additional blood samples at multiple time points in the study. In addition, sufficient tissue must be available (15 blank formalin fixed paraffin embedded tissue samples mounted on APES slides or a tissue block)
•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

排除标准

•Known cerebral or meningeal disease (HL or any other etiology), including signs or symptoms of Progressive Multifocal Leukoencenphalopathy
•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)
•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
•Concurrent anti-cancer treatment or use of any investigational agent(s)
•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
•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

结局指标

主要结局

Modified progression-free survival rate at 2 years after start of treatment (2yr-mPFS for each patient). The following are considered events for the primary endpoint: progression/relapse; start of new treatment for cHL when not in CR after completing protocol treatment; death from any cause.

次要结局

FDG-PET result (positive/negative) after 1 cycle of BrAVD (central assessment)
Response according to Lugano Criteria at end of protocol treatment i.e. after chemotherapy and after radiotherapy (if administered), as defined by FDG-PET/CT
Progression-free survival (where progression, relapse and death from any cause are considered events)
Overall survival
Safety and tolerability
Response according to RECIL 2017

研究者

发起方

European Organisation For Research And Treatment Of Cancer

申办方类型

Patient organisation/association

责任方

Principal Investigator

主要研究者

Stéphanie Kromar

Scientific

European Organisation For Research And Treatment Of Cancer

研究点 (16)

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