EUCTR2005-005242-39-DE进行中（未招募）不适用
Efficacy of WT1-peptide vaccination for remission maintenance in patients with acute myeloid leukemia: A controlled phase II trial - WT1-peptide study
Charité Campus Benjamin Franklin, Med. Clinic III,Dept. of Hematology,Oncology, Transfusion Medicine0 个研究点目标入组 122 人开始时间: 2006年6月14日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 122
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Male or female > 18 years of age
- •Diagnosis of AML
- •First CR or leukemia-free state in presence of unfavorable prognostic factors or second CR or leukemia-free state ( for definition see page 16).
- •WT1 expression in leukemia blast cells
- •Adequate bone marrow function: leucocytes > 1.0 x 109/L, neutrophils > 0.5 x 109/L, platelets > 50 x 109/L, hemoglobin > 9.0 g/dL
- •ECOG performance status 0-2
- •Absence of significant liver toxicity from chemotherapy: SGOT, SGPT, AP, g-GT < 3 x ULN
- •Adequate renal function: serum creatinine < 1.5 mg/d
- •If of childbearing potential, willingness to use effective contraceptive method for the study duration and 2 months post-dosing.
- •Signed written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Other serious illness or medical conditions:
- •Unstable cardiac disease despite treatment, congestive heart failure > NYHA grade 2-Significant renal disease
- •Active neurologic or psychiatric disorders including dementia or seizures;-Active uncontrolled infection
- •Active disseminated intravascular coagulation
- •Other serious underlying medical conditions which could impair the ability of the patient to participate in the study
- •Known allergic/hypersensitivity reaction to any of the components of the treatment·
- •Legal incapacity or limited legal capacity
- •Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent
研究者
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