Investigator-initiated Clinical Trial (Phase II) of Cancer Vaccine "DSP-7888" for Acute Myeloid Leukemia Patients.
试验速览
- 阶段
- 2 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Relapse-free survival
研究概览
简要总结
This study is an investigator-initiated clinical trial (Phase II) using DSP-7888 for acute myeloid leukemia patients with 1st hematological complete remission (CR). DSP-7888 is a novel cocktail peptide vaccine designed to induce cytotoxic T lymphocytes that recognize Wilms Tumor Gene 1 (WT1) peptides.
详细描述
This study is an investigator-initiated clinical trial (Phase II) using DSP-7888 for acute myeloid leukemia patients with 1st hematological CR. DSP-7888 is a novel cocktail peptide vaccine designed to induce cytotoxic T lymphocytes that recognize WT1 peptides. Primary endpoint is relapse-free survival, and 2nd endpoint is hematological relapse-free survival, overall survival and adverse event.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •acute myeloid leukemia defined by World Health Organization (WHO) 2016 classification
- •favorable or intermediate risk based on European Leukemia Net (ELN) 2017 risk classification
- •1st hematological after chemotherapy
- •Human Leukocyte Antigen (HLA)-A*02:01, 02:06, 24:02
- •20-80 years old
- •Eastern Cooperative Oncology Group (ECOG) performance Status 0-2
- •within 35 days after White Blood Cell (WBC) and Neutrophil recovers over 1500 and 500, respectively
- •sufficient organ function as below within 7 days
- •(1) Neutrophil : >= 1000 (2) Cr : >= 3.0mg/dl (3) Aspartate aminotransferase (AST), Alanine transaminase (ALT) : 5 x the upper limit of normal (ULN) for the reference lab (4) Percutaneous oxygen saturation (SpO2): >= 95% 9) patients who agree contraception until 6 months after the last injection 10) non-candidate for hematopoietic stem cell transplantation.
- •illegible for hematopoietic stem cell transplantation (HSCT)
- •lack of appropriate donor
- •patients who don't select HSCT at the 1st hematological complete remission (hCR) timing
排除标准
- •multiple primary cancer
- •autoimmune disease
- •usage of investigational or unapproved drug within 28 days
- •severe organ failure
- •Human Immunodeficiency Virus (HIV) antibody / Hepatitis B surface (HBs) antigen / Hepatitis C Virus (HCV) antibody positive
- •pregnant woman
- •lactating woman
- •under treatment against active infection
- •difficult to enroll because of mental problem
- •other reasons which investigator judge appropriate for enrollment
研究组 & 干预措施
Administration Group
Patients who are injected with DSP-7888.
干预措施: DSP-7888 (Drug)
结局指标
主要结局
Relapse-free survival
时间窗: 2 year
次要结局
- Overall survival(2 year)
- Hematological relapse-free survival(2 year)
- Adverse event(2 year)