JPRN-UMIN000028083已完成1 期
Phase I study of WT1-expressing human artificial adjuvant vector cells (aAVC-WT1) for patients with relapsed or refractory acute myeloid leukemia - Phase I study of WT1-expressing human artificial adjuvant vector cells (aAVC-WT1) for patients with relapsed or refractory acute myeloid leukemia
IMSUT Hospital, The Institute of Medical Science, The University of Tokyo0 个研究点目标入组 10 人开始时间: 2017年7月5日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
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
- 20years-old 至 ot applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •Acute promyelocytic leukemia, BCR-ABL-positive leukemia Central nervous system infiltration/extramedullary AML Sustained non-hematological toxicity ( >= Grade 2) related to prior therapy for AML Clinically relevant graft-versus-host disease required for treatment Duration from prior therapy to administration: 1) Systemic immunosuppressive drugs including steroids <= 14 days 2) Investigational drugs, products, or medical devices <= 4 weeks 3) Hematopoietic stem cell transplantation <= 8 weeks 4) Chemotherapy (excluding hydroxyurea for leukemia control) Laboratory examination <= 14 days prior to registration: 1) AST/ALT >= 3 times upper limit of normal level (ULN) 2) Total serum bilirubin level >= 2 times ULN 3) Lymphocytes (peripheral blood) <= 5.0 x 10^2 /microliter 4) Estimated glomerular filtration rate < 30 mL/min 5) SpO2 < 94% (room air) Other active malignancies Angina pectoris, acute myocardial infarction, congestive heart failure (>= NYHA class 3), or severe abnormality on electrocardiography <= 12 weeks prior to 1st administration Poor control hypertension, interstitial pneumonia, pulmonary fibrosis, chronic obstructive pulmonary disease (>= stage 3) Disseminated intravascular coagulation Active/poor control infection, HIV infection Active hepatitis B/C virus infection, other active liver disease Congenital/acquired immune deficiency Pregnant, possible pregnant, breast feeding women Poor control diabetes mellitus Known hypersensitivity to reagents (human albumin, etc.), additives (galactose/ceramide), antibiotics (streptomycin/gentamicin) and heterologous proteins (fetal bovine serum/porcine trypsin) Principal investigator/co-investigator judgement
研究者
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