跳至主要内容
临床试验/DRKS00031604
DRKS00031604招募中不适用

Characterization, long-term outcome, mechanisms, and treatment of CAR-T cell therapy-associated neurotoxicity - COHERENCY

Charité Universitätsmedizin Berlin, Klinik für Neurologie mit Experimenteller Neurologie0 个研究点目标入组 200 人开始时间: 2023年5月10日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
200

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

  • informed written consent
  • - Patient is capable of giving consent (capable of understanding the nature and expected benefits and risks of the proposed investigations)
  • - Minimum 18 years of age
  • - sufficient health insurance coverage
  • - Karnofsky Index =70%
  • - The participant belongs to one of the following groups:
  • # Patients/ patients with underlying hemato-oncologic disease for whom CAR T-cell therapy is planned.
  • # Patients with malignant hemato-oncological disease (preferably lymphoma, leukemia, multiple myeloma)
  • # healthy volunteers
  • # Patients with suspected CNS infection undergoing diagnostic lumbar puncture
  • # Patients with suspected or confirmed autoimmunological CNS disease undergoing diagnostic lumbar puncture.
  • - For cohorts 1-3: fluent in written and spoken German language

排除标准

  • - The patient is not willing to consent to the storage, processing and disclosure of pseudonymized medical data for study purposes
  • - The patient is under legal care or lawfully placed in an official institution
  • - To be applied for cohort 1-3 only:
  • # The patient has pre-existing (dementia, identifiable by a MOCA score of <15/30 pts.)
  • # The patient has a history of florid alcohol and/or drug abuse.
  • # The patient is currently suffering from a moderately depressive episode (recognizable by a BDI-FS score of =4 pts.)
  • # The patient has a pacemaker or a non-MRI capable implant.

研究者

发起方
Charité Universitätsmedizin Berlin, Klinik für Neurologie mit Experimenteller Neurologie

相似试验

进行中(未招募)
1 期
Evaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical TrialsMedDRA version: 20.0Level: SOCClassification code 10029205Term: Nervous system disordersSystem Organ Class: 10029205 - Nervous system disordersMedDRA version: 20.1Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disordersMultiple Sclerosis
EUCTR2019-000069-19-SEMerck KGaA1,000
进行中(未招募)
1 期
Evaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical TrialsMedDRA version: 20.0Level: SOCClassification code 10029205Term: Nervous system disordersSystem Organ Class: 10029205 - Nervous system disordersMedDRA version: 20.1Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disordersMultiple Sclerosis
EUCTR2019-000069-19-ITMERCK KGAA662
进行中(未招募)
1 期
Evaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical TrialsMedDRA version: 20.0Level: SOCClassification code 10029205Term: Nervous system disordersSystem Organ Class: 10029205 - Nervous system disordersMedDRA version: 20.1Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disordersMultiple Sclerosis
EUCTR2019-000069-19-ATMerck, S.L.1,000
进行中(未招募)
1 期
Evaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical TrialsMultiple Sclerosis
EUCTR2019-000069-19-LTMerck KGaA1,000
进行中(未招募)
1 期
Evaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical TrialsMedDRA version: 20.0Level: SOCClassification code 10029205Term: Nervous system disordersSystem Organ Class: 10029205 - Nervous system disordersMedDRA version: 20.1Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disordersMultiple Sclerosis
EUCTR2019-000069-19-ESMerck KGaA662