JPRN-UMIN000033351已完成1 期
A Phase I study of Inotuzumab Ozogamicin as a single agent for pediatric patients in Japan with relapsed/refractory CD22-positive Acute Lymphoblastic Leukemia - A Phase I study of Inotuzumab Ozogamicin as a single agent for pediatric patients in Japan with relapsed/refractory CD22-positive Acute Lymphoblastic Leukemia
ational Cancer Center Hospital Nagoya Medical Center Osaka City General Hospital Kyushu Cancer Center Hyogo Prefectural Kobe Children's Hospital0 个研究点目标入组 18 人开始时间: 2018年7月20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
- 18
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 17years-old（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1. Isolated extramedullary relapse (testicular or CNS) 2. Burkitt's or mixed phenotype acute leukemia (WHO 2008 criteria) 3. Active central nervous system leukemia. Prophylactic intrathecal medication is not excluded. 4. Having undergone prior chemotherapy at enrollment excluding therapy to reduce the circulating lymphoblast count or palliation: steroids, hydroxycarbamide, or vincristine 5. Prior administration of monoclonal antibodies within 4 weeks of enrollment 6. Prior rituximab treatment at enrollment 7. Prior allogeneic HSCT or other anti-CD22 immunotherapy <=4 months before enrollment 8. Having completed immunosuppression therapy in GvHD prior to enrollment. With >= Grade 2 acute GvHD, or extensive chronic GvHD at enrollment 9. Systemic vasculitides, or primary or secondary immunodeficiency 10.Active HbsAg B or HCV C infection or seropositivity for HIV 11. Major surgery within <=4 weeks before enrollment 12. Unstable or severe uncontrolled medical condition 13. Concurrent active malignancy excluding non-melanoma skin cancer that has been definitely treated with radiation or surgery, calculated cervical high grade squamous intraepithelial lesion (CIN2, CIN3), or localized prostate cancer. Those with previous malignancies in disease free for >=2 years 14. <45% cardiac function (left ventricular ejection fraction), or class >=3 (Modified Ross Heart Failure Classification) 15. Active heart disease 16. Myocardial infarction <=6 months before enrollment 17. History of chronic liver disease 18. History of hepatic veno-occlusive disease or sinusoidal obstruction syndrome 19. Live vaccine administration <=6 weeks before enrollment 20. Evidence of serious active infection 21. History of severe allergic or anaphylactic reaction to any humanized monoclonal antibodies 22. Participation in other studies 23. History of Inotuzumab ozogamicin administration
研究者
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