JPRN-jRCT2051200023招募中2 期
Investigator-initiated clinical trial (Phase II) of cancer vaccine DSP-7888 for acute myeloid leukemia patients. - WT1-AM-05
akata Jun0 个研究点目标入组 100 人开始时间: 2020年6月3日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
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
- >= 20age old 至 < 80age old（—）
- 性别
- All
入选标准
- •1) acute myeloid leukemia difined by WHO 2016 classification
- •2) favorable or intermediate risk based on ELN 2017 risk classification
- •3) 1st hematological after chemotherapy
- •4) HLA-A*02:01, 02:06, 24:02
- •5) 20-80 years old
- •6) ECOG performance Status 0-2
- •7) whithin 35 days after WBC and Neutrophil recovers over 1500 and 500, respectively
- •8) safficient organ function as below within 7 days
- •(1) Neutrophil : >= 1000
- •(2) Cr : >= 3.0mg/dl
- •(3) AST, ALT : 5 x the ULN for the reference lab
- •(4) SpO2: >= 95%
- •9) patients who agree contraception until 6 months after the last injection
- •10) non-candidate for hematopoietic stem cell transplantation.
- •(1) illegible for HSCT
- •(2) lack of appropriate donor
- •(3) patients who don't select HSCT at the 1st hCR timing
排除标准
- •1) multiple primary cancer
- •2) autoimmune disease
- •3) usage of investigational or unapproved drug within 28 days
- •4) severe organ failure
- •5) HIV antibody / HBs antigen / HCV antibody positive
- •6) pregnant woman
- •7) lactating woman
- •8) under treatment against active infection
- •9) difficult to enroll becuase of mental problem
- •10) other reasons which investigator judge appropriate for enrollment
研究者
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