JPRN-UMIN000016991已完成2 期
Phase II trial (Investigator-initiated clinical trial) of CH5424802 in patients with relapsed or refractory ALK-positive anaplastic large cell lymphoma - Investigator-initiated trial of CH5424802 against relapsed or refractory ALK-positive ALC
ational Hospital Organization Nagoya Medical Center Hirokazu Nagai St.Marianna University School of Medicine Hospital Tetsuya Mori National Hospital Oganization Kyusyu cancer center Che Irusun0 个研究点目标入组 10 人开始时间: 2015年4月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
研究概览
简要总结
in preparation
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 6years-old 至 ot applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1) Patients in whom the latest diagnosis is primary cutaneous ALCL/2)Patients in whom active viral, bacterial, or fungal infection has been observed within 2 weeks before the first administration of the investigational product/3) Patients with poorly controlled diabetes/4) Patients with a history or complication of another malignant neoplasm that has not been cured for 3 years or longer/5) Patients with CNS lesions/6) Patients showing signs or symptoms suggestive of PML/7) Patients with a history of severe hypersensitivity or allergy/8) Patients positive for HIV antibody, HBs antigen, HBs antibody, HBc antibody, or HVC antibody/9) Patients with liver cirrhosis/10) Patients who have received ASCT within 12 weeks before the first administration of the investigational product/11) Patients who have received allogeneic hematopoietic stem-cell transplantation/12) Patients who have received treatment for a malignant neoplasm within 4 weeks before the first administration of the investigational product/13) Patients who have been administered an adrenocorticosteroid hormone preparation for the treatment of lymphoma within 7 days before the first administration of the investigational product./14) Patients administered another investigational product or treated using an investigational instrument within 4 weeks./15) Patients who received a treatment specifically targeting ALK in the past./16) Patients known to have hypersensitivity to additives contained in the investigational product./17) Patients who are pregnant, breast-feeding, or may be pregnant, or do not consent to contraception for 6 months after the last administration of the investigational product./18) Patients who have a disability that impairs their ability to consent in writing or conform to the trial procedure./19) Patients who have been judged by the investigator to be inappropriate for participation in this clinical trial for other reasons.
研究者
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