EUCTR2018-004869-14-DK进行中（未招募）1 期
Peptide vaccination with PD-L1 and PD-L2 peptides in untreated chronic lymphatic leukemia.
Dept. of hematology, Herlev Hospital0 个研究点目标入组 20 人开始时间: 2019年2月7日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
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
- •CLL according to national guidelines.
- •Unmutated IGHV gene
- •No prior CLL directed treatment
- •ECOG performance status of 0 or 1
- •No life-threatening conditions
- •Adequate hematologic and end-organ function
- •Bone marrow function: Neutrophilocytes > 1,0 x 109/l; Platelets > 100 x 109/l
- •Renal function: eGFR/1,73m^2 > 50
- •For fertile women: agreement to use contraceptive methods with a failure rate of < 1% per year during the treatment period and for at least 120 days after the last treatment.
- •For men: agreement to use contraceptive measures and agreement to refrain from donating sperm.
- •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 10
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •Other active malignant diseases requiring treatment.
- •Significant medical condition per investigators judgement e.g. severe Astma/COLD, poorly regulated heart condition, insulin dependent diabetes mellitus.
- •Acute or chronic viral/bacterial infection e.g. HIV, CMV, EBV, hepatitis or tuberculosis
- •Serious known allergies or earlier anaphylactic reactions.
- •Known sensibility towards Montanide ISA-51
- •Any active autoimmune diseases e.g. autoimmune neutropenia, thrombocytopenia or hemolytic anemia, systemic lupus erythematosus, scleroderma, myasthenia gravis, autoimmune glomerulonephritis, autoimmune adrenal deficiency, autoimmune thyroiditis etc.
- •Pregnant and breastfeeding women.
- •Fertile women not using secure contraception with a failure rate less than < 1%
- •Psychiatric disorders that according to the investigator could influence compliance.
- •Treatment with other experimental drugs
研究者
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