NL-OMON50149招募中2 期
Very early FDG-PET-response adapted targeted therapy for advanced Hodgkin lymphoma: a single-arm phase II study - COBRA
European Organisation for Research in Treatment of Cancer (EORTC)0 个研究点目标入组 38 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 38
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 64（—）
入选标准
- •- Classical Hodgkin lymphoma, histologically proven, previously untreated
- •- Staged by FDG-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)
- •> Stage III - IV
- •- Age >=18 and <=60
- •- WHO performance status 0-2 (Appendix C)
- •- Adequate organ function (for specification see 3.1.1 protocol page 24)
- •- Absence of any medical, psychological, familial, sociological or geographical
- •condition potentially hampering compliance with the study protocol and
- •follow-up schedule.
- •- Participation in translational research is mandatory and therefore patient
- •must consent for it.
- •- Negative pregnancy serum test < 72 h prior to 1st treatment (WOCBP)
- •- Willing to comply with birth control methods (protocol 3.1.1.) during the
- •study and 6 months after last treatment dose
- •- Written informed consent
排除标准
- •- Cerebral or meningeal disease (HL or any other etiology), including signs or
- •symptoms of Progressive Multifocal Leukoencephalopathy
- •- Symptomatic neurologic disease compromising normal activities of daily living
- •or requiring medications
- •- Sensory or motor peripheral neuropathy >= grade 2 according to CTCAE version
- •- Cardiovascular conditions (specifications see protocol 3.1.2 p 25)
- •- 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 , non-melanoma
- •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)
研究者
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