EUCTR2013-000734-35-FR进行中（未招募）1 期
Brentuximab vedotin as consolidation treatment in patients with stage I/II Hodgkin’s lymphoma and FDG-PET positivity after 2 cycles of ABVD - BRAPP2
YSARC0 个研究点目标入组 40 人开始时间: 2014年7月31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
- 40
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
- •1. Patients must have histologically confirmed CD30+ classical Hodgkin lymphoma
- •2. Patients must have provided voluntary written informed consent before performance of any study-related procedures not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care
- •3. Supradiaphragmatic Ann Arbor clinical stage I or II (favourable and unfavourable according to the EORTC/GELA clinical prognostic factors)
- •4. Mandatory FDG-PET/ CT without IV contrast performed at diagnosis
- •5. Patients treated with first-line ABVD and FDG-PET positive after 2 cycles (Deauville score 4&5)
- •6. Patients must have an ECOG performance status of 0-2
- •7. Life expectancy > 6 months
- •8. Patients must be 18-70 years of age
- •9. Patients must be available for periodic blood sampling, study-related assessments, and management of toxicity at the treating institution
- •10. Clinical laboratory values as specified below before the first dose of study drug:
- •Absolute neutrophil count = 1,500/µL
- •Platelet count = 75,000/ µL Total bilirubin must be < 1.5 x the upper limit of the normal (ULN) unless the elevation is known to be due to Gilbert syndrome
- •ALT or AST must be < 3 x the upper limit of the normal range
- •Serum creatinine must be < 2.0 mg/dL and/or creatinine clearance or calculated creatinine clearance > 40 mL/minute
- •Hemoglobin must be = 8g/dL
- •11. Patient affiliated to social security system
- •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 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •1. Patients with dementia or altered mental status that would preclude compliance with drug delivery
- •2. Women who are pregnant or breastfeeding
- •3. Women of childbearing potential and men not practicing an adequate method of contraception during the study treatment and at least 6 months after the last study drug administration
- •4. Patients with symptomatic pulmonary disease
- •5. Patients with known history of any of the following cardiovascular conditions:
- •Myocardial infarction within 2 years of inclusion
- •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
- •Recent evidence (within 6 months before first dose of study drug) of a left-ventricular ejection fraction <50%
- •6. Any history of cancer or cancer treatment during the last 3 years with the exception of non-melanoma skin cancer or stage 0 (in situ) carcinoma of any type if they have undergone complete resection
- •7. Uncontrolled infectious disease, including active HBV infection defined by either detection of HBs Antigen or presence of anti HBc antibody without detectable anti HBs antibody
- •8. Any active systemic viral, bacterial, or fungal infection requiring systemic antibiotics at the time of inclusion and planned to be still on going within 2 weeks prior to first study drug dose
- •9. Known HIV, known or suspected HCV or HTLV serology positivity
- •10. Patients who have been treated previously with any anti-CD30 antibody
- •11. Known hypersensitivity to any excipients contained in the brentuximab vedotin formulation
- •12. Known cerebral or meningeal disease (HL or any other etiology), including signs or symptoms of Progressive Multifocal Leukoencephalopathy (PML)
- •13. Any sensory or motor peripheral neuropathy greater than or equal to Grade 2
- •14. Patients that have not completed any prior treatment chemotherapy, except ABVD, and/or other investigational agents within at least 5 half-lives of last dose of that prior treatment
研究者
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