A Phase I Study of OCV-501 in the Treatment of Patients With Acute Myeloid Leukemia
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Occurrence of Dose Limiting Toxicities
研究概览
简要总结
The purpose of this study is to assess the safety, tolerability of OCV-501 in patients with acute myeloid leukemia (AML) who achieved complete remission after induction regimen and who completed a standard consolidation therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with acute myeloid leukemia including patients with secondary leukemia. However, the patients with MDS apparently evolved itno AML and patients with AML accompanied by t(15;17)(q22;q12),(PML/RARalpha) , should be excluded.
- •Patients who achieved the first complete remission after the induction regimen and finished a standard consolidation therapy.
- •Age: ≥ 60years of age(at the time of signature of the informed consent form)
- •Sex: Male and Female
- •Patients who are capable of giving informed consent
- •Patient's blasts cells show expression of WT1mRNA, detected by quantitative RT-PCR.
- •Patients must be one of the following HLA DRB1 types: HLA-DRB1*01:01, *04:05, *15:01, *15:02, *08:03 and *09:
排除标准
- •Patients who are scheduled for a bone marrow transplantation
- •Patients who were administered exceeded acceptable therapeutic dose of immunosuppressants and adrenal cortical steroids.
- •Patients with uncontrollable active infectious diseases
- •Patients with autoimmune diseases (including Hashimoto's disease, idiopathic thrombocytopenic purpura, and autoimmune hepatitis) or with a medical history of active autoimmune diseases
- •Immunocompetent patients
- •Patients with a complication of interstitial pneumonia or with a medical history of interstitial pneumonia
研究组 & 干预措施
Cohort 1
0.3 mg
干预措施: OCV-501 (Drug)
Cohort 2
1 mg
干预措施: OCV-501 (Drug)
Cohort 3
3 mg
干预措施: OCV-501 (Drug)
结局指标
主要结局
Occurrence of Dose Limiting Toxicities
时间窗: 4 Weeks
Dose limiting toxicity (DLT) was defined as any of the following adverse events occurring by Day 29 (7 days after the last investigational medicinal product \[IMP\] administration) of this trial for which a causal relationship to the IMP could not be ruled out. Severity of the adverse events was evaluated in accordance with the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) ver. 4.0. Blood toxicity did not include hematology parameters of laboratory tests. * Non-blood toxicities ≥ Grade 3, excluding cases of anorexia, nausea, vomiting, diarrhea, and constipation where it is possible to continue the clinical trial by use of supportive therapy * Blood toxicities ≥ Grade 4, although febrile neutropenia ≥ Grade 3 will be counted as DLT.
次要结局
- Recurrence Based on the Response Evaluation Criteria by the International Working Group(4 weeks)