EUCTR2015-005817-61-DE进行中（未招募）1 期
iVAC-CLL01: Patient-individualized peptide vaccination after first line therapy of CLL - iVAC-CLL01
niversity Hospital Tuebingen0 个研究点目标入组 56 人开始时间: 2016年4月13日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 56
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
入选标准
- •1. Documented diagnosis of CLL/SLL according to IWCLL
- •guidelines.
- •For Screening phase:
- •No pretreatment of CLL/SLL
- •Ability to mount an immune response: Positive
- •immunresponse to EBV/CMV peptide mix (analyzed
- •in 12 day recall IFN? ELISPOT).
- •For Vaccination phase:
- •Achievement of response (at least PR according to
- •IWCLL guidelines) after first-line therapy according
- •to treating physicians choice.
- •2. HLA typing positive for HLA alleles of peptides included in
- •the warehouse with proven immunogenicity: HLA-A*01, A*02,
- •A*03, A*24, B*07, B*08.
- •3. Ability to understand and voluntarily sign an informed
- •consent form.
- •4. Age = 18 years at the time of signing the informed consent
- •5. Ability to adhere to the study visit schedule and other
- •protocol requirements.
- •6. Eastern Cooperative Oncology Group (ECOG) performance
- •status score of = 2.
- •7. Negative serological Hepatitis B and C test or negative PCR
- •in case of positive serological test without evidence of an
- •active infection, negative HIV test within 6 weeks prior to
- •randomization.
- •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 56
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. High risk CLL/SLL
- •17p-deletion or
- •TP53 mutation
- •2. Pregnant or lactating females.
- •3. Participation in any clinical study or having taken any
- •investigational therapy, which would interfere with the studys
- •primary end point.
- •4. Patients who have received any other vaccine within 1
- •month prior to study inclusion.
- •5. Prior history of malignancies, other than CLL, unless the
- •subject has been free of the disease for = 5 years. Exceptions
- •include the following:
- •Basal cell carcinoma of the skin
- •Carcinoma in situ of the cervix
- •Carcinoma in situ of the breast
- •Incidental histological finding of prostate cancer (TNM
- •stage of T1a or T1b)
- •6. Any of the following laboratory abnormalities:
- •For Vaccination phase:
- •7. Disease transformation (active) (i.e. Richter’s Syndrome,
- •prolymphocytic leukemia).
- •8. Any immunosupressive treatment except corticosteroids.
研究者
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