JPRN-jRCT1091220229已完成1 期
Phase I clinical study of brentuximab vedotin(SGN-35) involving children with recurrent or refractory CD30-positive Hodgkin's lymphoma or systemic anaplastic large cell lymphoma (physician-led clinical study) - BV-HLALC
ational Hospital Organization Nagoya Medical Center Keizo Horibe0 个研究点目标入组 6 人开始时间: 2015年11月17日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 6
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
- >= 2age old 至 < 18age old（—）
- 性别
- All
入选标准
- •1) Asian patients aged 2 to 17 years on obtaining informed consent.
- •2) Those definitively diagnosed with CD30-positive HL or sALCL based on histological findings. A report or its copy describing that a specimen collected at the time of initial diagnosis or relapse was evaluated as positive for CD30 using an immunohistochemical procedure or flow cytometry is stored in the hospital.
- •3) Those with PD during standard chemotherapy or without CR/PR after treatment, or those with relapse or additional exacerbation after standard chemotherapy.
- •4) Those with an ECOG performance status (PS) of 0 to 2.
- •5) Those whose laboratory data on screening meet the following criteria. The administration of a gene recombinant human granulocyte-colony stimulating factor (G-CSF) preparation or blood transfusion is not performed within1 week before neutrophil and platelet count tests:
- •-Neutrophil count: >= 1,500/microL
- •-Platelet count: >= 75,000/microL
- •-Hemoglobin level: >= 8 g/dL
- •-Serum bilirubin level: <= 1.5-fold the upper limit of the normal (ULN) in the facility
- •-Serum creatinine level: <= 1.5-fold the ULN
- •-Alanine aminotransferase (ALT) and aspartate aminotransferase (AST): <= 2.5-fold the ULN
- •6) Those who are expected to survive for >=3 months on obtaining informed consent.
- •7) Written informed consent regarding participation in this clinical study could be obtained from subjects and/or representatives.
排除标准
- •1) Patients diagnosed with primary ALCL of the skin as the latest diagnosis (those with infiltration in other organs and an sALCL-like condition are regarded as eligible).
- •2) Those after the resection of all lesions.
- •3) Those with active viral, bacterial, or fungal infection within 2 weeks before the initial administration of SGN-35.
- •4) Those with >=grade III heart failure (New York Heart Association (NYHA) severity classification), refractory coronary disease, arrhythmia, a left ventricular ejection fraction of <50%, angina pectoris, or acute ischemia or active conduction disorder on electrocardiography, or those with a history of myocardial infarction within 6 months before the initial administration of SGN-35.
- •5) Those with refractory diabetes.
- •6) Those with a history of other malignant tumors persisting for >= 3 years and complications. However, the following cancers are excluded:
- •-Completely resected non-melanoma skin cancer
- •-Completely resected intraepithelial carcinoma
- •7) Those with intra-cerebral or meningeal infiltration.
- •8) Those with signs or symptoms suggesting progressive multifocal leukoencephalopathy (PML).
- •9) Those with a history of severe hypersensitivity or allergy.
- •10) Human immunodeficiency virus (HIV) antibody-, hepatitis B virus surface antigen (HBs antigen)-, hepatitis B virus surface antigen antibody (HBs antibody)-, hepatitis B virus core antigen antibody (HBc antibody)-, or hepatitis C virus (HCV) antibody-positive patients on a screening test. However, patients with a history of hepatitis B vaccination who are positive for HBs antibody alone will not be excluded.
- •11) Patients with liver cirrhosis.
- •12) Those in whom autologous stem cell transplantation (ASCT) was performed within 12 weeks before the initial administration of SGN-35.
- •13) Those in whom homologous stem cell transplantation was performed.
- •14) Those who received treatment for malignant tumors (radiotherapy, chemotherapy, and hormonal therapy) within 2 weeks before the initial administration of SGN-35. However, those who received biological preparations in a longer period: either 6 weeks before the initial administration of this drug or a period corresponding to 5-fold the half-life, will be excluded.
- •15) Those who received the systemic administration of adrenocorticohormones at a non-steady dose within 1 week before the initial administration of SGN-35.
- •16) Those who took drugs that inhibit CYP3A4 (clarithromycin, itraconazole, verapamil, and diltiazem) or ingested foods/supplements (such as grapefruit) within 1 week before the initial administration of SGN-35.
- •17) Those who took drugs that induce CYP3A4 (phenytoin, phenobarbital, rifampicin, carbamazepine) or ingested foods/supplements (such as St. John's wort) within 2 weeks before the initial administration of SGN-35.
- •18) Those to whom other investigational drugs were administered within 4 weeks before the initial administration of SGN-35.
- •19) Those in whom medical instruments under a clinical study were used within 4 weeks before the initial administration of SGN-35.
- •20) Those with hypersensitivity to additives contained in the composition of SGN-35.
- •21) Pregnant (human chorionic gonadotropin-positive) or lactating patients.
- •22) Those who are not willing to conduct appropriate contraception from informed consent acquisition until 6 months after the final administration of the investigational drug.
- •23) Those with positive reactions on a pregnancy test at the time of screening or on Day 1 of Cycle
研究者
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