IMMUNOTHERAPY WITH INTRAVENOUS IMMUNOGLOBULINS, CYCLOPHOSPHAMIDE AND METHYLPREDNISOLONE IN PATIENTS WITH PARANOPLASTIC SENSITIVE NEURONOPATHIES WITH ANTI-HU ANTIBODIES - NESPA

ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)0 个研究点开始时间: 2019年4月12日最近更新: 2021年4月26日

试验速览

暂无简介。

•-Age = 18 years
•-Neuropathic sensory possible according to the criteria of Camdessanché et al.
•-Dominant ataxia table (central nervous system involvement and / or neuromuscular junction is allowed, provided it has a minor impact on the patient's disability)
•-Anti-Hu antibody positive in blood and / or cerebrospinal fluid
•-Outpatient (modified Rankin score 2 or 3)
•-First neurological symptoms for less than 3 months
•-Free, informed, written and signed consent
•-Affiliation to a social security scheme or beneficiary (except AME)
•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 11
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 10

•-Possible hypersensitivity to any of the study treatments, their metabolites, or any of the excipients
•-Absolute contraindications to intravenous immunoglobulin : selective IgA deficiency, known thrombophilia
•-Absolute contraindications to cyclophosphamide: vaccination against yellow fever in the 3 months preceding inclusion, acute urinary tract infection, acute spinal cord failure
•-Over two courses of IVIG administered within 3 months before recruitment
•-Other concomitant immunotherapy
•-Other cause of immunodepression (acquired or congenital)
•-Treatment with checkpoint inhibitors in progress or completed less than 3 months ago
•- Women of childbearing age without effective contraception, pregnant or lactating
•-Psychiatric history or general illness that may contraindicate the treatment
•-Patients unable to perform the follow-up required by the study
•-Patients under guardianship or curatorship
•-Patient deprived of liberty by a judicial or administrative decision

发起方