JPRN-jRCT1080223510已完成1 期
A Multicenter Phase I/II Study for Relapsed or Refractory CD19+ B-acute Lymphoblastic Leukemia
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 21
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
- >= 16age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1.In phase I, patients must be more than 18 years of age. In phase II, patients must be more than 16 years of age.
- •2.Patients with relapse or refractory CD19+ acute B-cell lymphoblastic leukemia
- •3.Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
- •4.Patients must have adequate key organ function (bone marrow, heart, lung, liver, renal, etc), as defined below
- •- Total bilirubin level more than 1.5xULN (Upper limit of normal)
- •- AST(GOT)/ALT(GPT) level more than 5.0xULN
- •- Serum creatinine more than 2.0mg/dL
- •- SpO2 more than 92%
- •- LVEF more than 50%
- •5.Patients must be able to understand and willing to sign a written informed consent document (for patients under 20 years of age their legal guardian must give informed consent).
排除标准
- •1.White blood cell counts more than 50,000/uL
- •2.Received expected antitumor therapy (chemotherapy or radiation therapy, etc) within 2 weeks.
- •3.Received HSCT within 12 weeks before enrollment.
- •4.Under treatment for GVHD.
- •5.lymphocytes except for blasts more than 500/uL
- •6.Presence of active CNS-3
- •7.Concurrent use of systemic steroids or immunosuppressive agents (except for replacement therapy and local administration. e.g. inhalation, application and so on).
- •8.HBs Ag positive ,or either HBc Ab positive or HBs positive with HBV-DNA over 1.3LogIU/ml
- •9.Presence of active hepatitis C infection
- •10.HIV Ab or anti-HTLV-1 Ab positive
- •11.History of allergy about component of investigational product or animal(cattle and/or mouse)-derived additives
- •12.Hypersensitivity to antibiotics.
- •13.Presence of symptomatic cardiac arrhythmias or serious heart disease.
- •14.Presence of another malignant tumor.
- •15.Psychiatric disorder, alcohol addiction or drug addiction that affects the ability of informed consent.
- •16.Active or serious infection.
- •17.Both men and women who have generative functions, and who cannot agree with using contraceptive devices from the day of the consent to the end of study.
- •18.Pregnant or lactating women.
- •19.Any other patients judged by the investigators to be inappropriate for the study.
研究者
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