EUCTR2013-000182-37-BE进行中（未招募）1 期
BRENTUXIMAB VEDOTIN ASSOCIATED WITH CHEMOTHERAPY IN UNTREATED PATIENTS WITH STAGE I/II UNFAVOURABLE HODGKIN LYMPHOMA - A RANDOMIZED PHASE II LYSA-FIL-EORTC INTERGROUP STUDY - BREACH
YSARC0 个研究点目标入组 170 人开始时间: 2014年11月13日最近更新:
适应症
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
- 170
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
- •Histologically confirmed CD30+ classical Hodgkin lymphoma according to local evaluation
- •Supradiaphragmatic Ann Arbor clinical stage I or II
- •Previously untreated
- •PET scan without IV contrast at diagnosis available for central review with at least one hypermetabolic lesion
- •Unfavourable (U) characteristics according to the classic EORTC/LYSA clinical prognostic factors. Unfavourable (U) subset includes patients with at least one of the following factors:
- •oCSII = 4 nodal areas
- •oage = 50 yrs
- •oM/T ratio = 0.35
- •oESR = 50 (without B-symptoms) or ESR = 30 with B-symptoms
- •ECOG performance status 0-2
- •Life expectancy > 6 months
- •Age 18 to 60 years (= 18 years to = 60 years)
- •Patients must be available for periodic blood sampling, study-related assessments, and management of toxicity at the treating institution.
- •Female patients who:
- •oAre postmenopausal for at least 1 year before the screening visit, OR are surgically sterile,
- •oIf they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent through 6 months after the last dose of study drug, or agree to completely abstain from heterosexual intercourse
- •Male patients, even if surgically sterilized (ie, status postvasectomy), who:
- •oAgree to practice effective barrier contraception during the entire study treatment period and through 6 months after the last dose of study drug, or agree to completely abstain from heterosexual intercourse.
- •Patients must give written informed consent. A copy of the informed signed consent form will be retained in the patient’s chart.
- •Required baseline laboratory data:
- •oAbsolute neutrophil count = 1,500/µL
- •oPlatelet count = 75,000/ µL
- •oHemoglobin = 8g/dL
- •oSerum total bilirubin = 1.5 X ULN unless the elevation is known to be due to Gilbert syndrome.
- •oSerum creatinine = 2.0 mg/dL and/or calculated creatinine clearance > 40 mL/minute (Cockcroft-Gault formula or MDRD)
- •oAlanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 3 X ULN
- •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 170
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Histological diagnosis different from classical Hodgkin Lymphoma. Nodular lymphocyte predominant subtypes (nodular paragranuloma or Poppema paragranuloma) are excluded.
- •Known cerebral or meningeal disease of any etiology, including signs or symptoms of PML
- •Any sensory or motor peripheral neuropathy = Grade 2
- •Known history of any of the following cardiovascular conditions
- •oMyocardial infarction within 2 years of randomization
- •oNew York Heart Association (NYHA) Class III or IV heart failure (see Appendix 14)
- •oEvidence of current uncontrolled cardiovascular conditions, including cardiac arrhythmias, congestive heart failure (CHF), angina, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities
- •oRecent evidence (within 30 days before first dose of study drug) of a left-ventricular ejection fraction <50%
- •Unstable diabetes mellitus (to avoid uninterpretable FDG-PET scan).
- •Known HIV positive
- •HCV positive
- •HBV positive. This means:
- •oHBsAg positive
- •oHBsAg negative, anti-HBs positive and/or anti-HBc positive and detectable viral DNA
- •?Patients who are HBsAg negative and viral DNA negative are eligible
- •?Patients who are seropositive due to a history of hepatitis B vaccine are eligible.
- •Any history of cancer during the last 5 years, with the exception of non-melanoma skin tumors. Carcinoma in situ of any type are not excluded if they have undergone complete resection.
- •Dementia or altered mental status that would preclude compliance with drug delivery
- •Pregnancy or breastfeeding. Females of childbearing potential having a positive ß-HCG pregnancy test result during screening or a positive pregnancy test (urinary or blood) within 1 day before start of treatment.
- •Previous treatment with any anti-CD30 antibody.
- •Known hypersensitivity to any excipients contained in the brentuximab vedotin formulation or known contra-indication to any drug contained in the chemotherapy regimens (for ex.: pulmonary or neurological disease grade = 2)
- •Treatment with corticosteroids before baseline PET scan (PET 0)
- •Patients with known active viral, bacterial, or fungal infection requiring treatment with antimicrobial therapy or with untreated known active Grade 3 viral, bacterial, or fungal infection, within 2 weeks prior to the first dose of brentuximab vedotin
- •Treatment with any investigational drug within 30 days before planned first cycle of chemotherapy or immune-chemotherapy
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