JPRN-UMIN000015980已完成1 期
A phase I study (investigator-initiated) on the safety and pharmacokinetics of Bortezomib with combination chemotherapy in pediatric and young adult patients with refractory acute lymphocytic leukemia - Bortezomib for relapsed ALL (BZM-ALL-1)
St.Luke's International Hospital Daisuke Hasegawa National Hospital Organization Nagoya Medical Center Naoko Maeda Fukushima Medical University Hospital Atsushi Kikuta0 个研究点目标入组 3 人开始时间: 2014年12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
- 3
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
- 1years-old 至 29years-old（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1) Mature B-cell ALL (L3) 2) Previous treatment with Bortezomib 3) The following complications/previous histories: 1. Concurrent infection requiring systemic treatment at enrollment. 2. Previous cardiac disease: previous myocardial infarction/angina pectoris within 12 months before enrollment. 3. Patients requiring oxygenation or showing respiratory insufficiency. 4. Previous interstitial pneumonia or pulmonary fibrosis. 5. Abnormal pulmonary function test, KL-6, SP-D, and SP-A as demonstrated by screening tests. 6. Abnormal beta-D glucan, Candida antigen, and Aspergillosis antigen as demonstrated by screening tests. 7. Previous deep fungus infection. 8. CNS or peripheral disorder. 9. Other complications determined to seriously compromise conducting of the study (for example, uncontrollable diabetes). 4) Down syndrome 5) Active double cancer (simultaneous double cancer, and metachronous double cancer with up to a 5-year disease-free period; carcinoma in situ determined as cured with local therapy or lesions consistent with intramucosal carcinoma are not included in double cancer.) 6) Determined as difficult to participate in the study because of complicated psychiatric disease or mental symptoms. 7) Participation in other clinical studies, excluding those of ALL, within 30 days after obtaining consent. 8) Pregnant or possibly pregnant women. Breastfeeding women. Men and women providing no consent to avoiding pregnancy during the study. 9) Previous hypersensitivity to mannitol, boron, or other components of Bortezomib. 10) Patients determined as ineligible for participation in the study by an investigator/sub-investigator for other reasons.
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