Paraneoplastic Neurological Syndromes
Conditions
Interventions
Trade Name: Privigen 100 mg/ml
Pharmaceutical Form: Solution for infusion
Product Name: cyclophosphamide
Pharmaceutical Form: Powder and solvent for solution for infusion
Product Name: méthylprednis
Sponsors
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -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
Exclusion criteria
Exclusion criteria: -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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluation of the 3-Month Efficacy of Early Immunotherapy with IgIV, Cyclophosphamide and Methylprednisolone in Patients with Paraneoplastic Sensory Neuronopathy with anti-Hu antibody;Secondary Objective: Evaluation : -of effectiveness at 6 months of study immunotherapy -of the percentage of patients alive and without tumor progression at 6 months -treatment tolerance;Primary end point(s): Percentage of patients with clinical improvement on the ONLS (Overall Neuropathy Limitations Scale) at 3 months;Timepoint(s) of evaluation of this end point: 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -The percentage of patients with clinical improvement on the ONLS scale at 6 months -The percentage of patients with improvement of the ataxic component on the Score of Ataxia scale at 3 and 6 months -The percentage of patients with improvement in neuropathic pain on the Numeric Rating Scale (NRS) at 3 and 6 months -The percentage of patients with functional improvement on the modified Rankin Score (mRS) at 3 and 6 months -The percentage of patients with functional improvement on the Barthel Index (BI) at 3 and 6 months -The percentage of patients alive and without tumor progression at 6 months -The tolerance to treatment will be evaluated by the frequency and severity of expected and unexpected adverse effects recorded during treatment;Timepoint(s) of evaluation of this end point: 3 and 6 months | — |
Countries
France
Contacts
Public ContactSophie COURTIAL-DESTEMBERT
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
Outcome results
None listed