DRKS00032520尚未招募不适用
eurological adverse events in tumor patients receiving CAR-T-cells and immune checkpoint inhibitors: clinical and molecular patterns of toxicityeffects - PARTICIPATE
niversitätsklinikum Jena0 个研究点目标入组 220 人开始时间: 2023年8月18日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 220
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •Inclusion criteria ICI cohort:
- •- Age = 18 years, female or male sex.
- •- Capacity to consent given or legal guardian available
- •- Informed consent available
- •- Histologically confirmed bronchial carcinoma (NSCLC), metastasized
- •melanoma or urological tumor
- •- Therapy regime with immune checkpoint inhibition indicated &.
- •Treatment planned at UKJ
- •- ECOG status 0-2 / Karnofsky index > 50 %***
- •- MRI suitability given
- •- No known gadolinium intolerance/contraindication
- •- No intake of steroids > 3 mg dexamethasone or
- •Equivalent at the time of study enrollment
- •Inclusion criteria CAR T-cell cohort:
- •- Age = 18 years, female or male sex.
- •- Capacity to give consent given or legal guardian available
- •- Informed consent available
- •- histologically confirmed hematological neoplasia, depending on the preparation
- •with approved indication for treatment with CAR-T at the time of individual recruitment
- •indication for treatment with CAR-T cells in Germany (e.g.
- •B-cell lymphoma, leukemias)
- •- Therapy with CAR-T cells in the hematooncological tumor board
- •indicated & treatment planned at UKJ
- •- ECOG status 0-2 / Karnofsky index > 50 %***
- •- MRI suitability given
- •- No known gadolinium intolerance/contraindication
- •- No use of steroids at the time of study enrollment
- •(> 3 mg dexamethasone or equivalent)
- •Inclusion criteria physician's choice cohort:
- •(PARTICIPATE control group):
- •- Age = 18 years, female or male sex.
- •2023_06_13 Version 1.3_PARTICIPATE Protocol Page 12 of 65
- •- Capacity to consent given or legal guardian present.
- •- Informed consent available
- •- Histologically confirmed hematological neoplasia (if possible
- •matched pairs strategy with respect to line of therapy and entity of the
- •CAR T-cell target cohort), bronchial carcinoma, metastatic melanoma
- •melanoma or urological tumor
- •- Systemic treatment planned at UKJ
- •- Oncologic systemic treatment (except immunotherapies!) indicated & planned at the UKJ
- •- No preceding or parallel planned ICI therapy
- •- ECOG status 0-2 /Karnofsky index > 50 %***
- •- MRI suitability given
- •- No known gadolinium intolerance/contraindication
- •- No use of steroids > 3 mg dexamethasone or equivalent
排除标准
- •- No Informed Consent available
- •- Simultaneous participation in an interventional clinical trial
- •- Presence of further tumor diseases requiring treatment
- •(incl. exclusive need for radiotherapy or surgery),
- •other than systemically treated entity; except for
- •treated prostate carcinoma with PSA < 0.2 ng/ml as well as non-invasive
- •dermatologic tumors (basal cell carcinomas /
- •squamous cell carcinomas)
- •- Presence of a persistent neurological disorder CTCAE grade 4
- •or persistent pre-therapy associated neurotoxicity grade
- •4 at the time of therapy initiation
- •- MRI suitability not given, e.g. in case of
- •a. pronounced obesity with BMI >30 kg/m²
- •b. Condition after pacemaker fitting
- •c. non-MR compatible implants, e.g. port system
- •- known gadolinium intolerance/contraindication
- •- Relevant drug immunosuppression prior to initiation of
- •Immune checkpoint inhibition (incl. > 3 mg dexamethasone or
- •equivalent)
- •- Other known immunosuppression (e.g., as congenital
- •immunodeficiency syndrome)
- •- Pregnancy or lactation
- •- Presence of a contagious infectious disease
- •(especially HIV, hepatitis B or C) at the time of study enrollment
研究者
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