HUMAN NORMAL IMMUNOGLOBULIN (IV) for paraneoplastic sensory neuropathy with anti-Hu antibodies

Inclusion criteria

• {"criterion_text":"- Adult patients with anti-Hu antibody paraneoplastic sensory neuropathy"}
• {"criterion_text":"- Age ≥ 18 years old"}
• {"criterion_text":"- \"Possible\" sensory neuropathy according to the criteria of Camdessanché et al."}
• {"criterion_text":"- dominant picture of sensitive ataxia (damage to the central nervous system and/or neuromuscular junction is accepted, provided that it has a minor impact on the patient's disability)"}
• {"criterion_text":"- Positive anti-Hu antibodies in blood and/or cerebrospinal fluid"}
• {"criterion_text":"- Outpatient (Modified Rankin Score (mRS) 2 or 3)"}
• {"criterion_text":"- Electroneuromyogram (ENMG) leading to diagnosis of sensory neuronopathy less than 3 months old"}
• {"criterion_text":"- Inform consent Free, written and signed"}
• {"criterion_text":"- Registered with a social security scheme or beneficiary (except AME)"}

Exclusion criteria

• {"criterion_text":"- Known hypersensitivity to one of the treatments under study, to their metabolites, or to one of the excipients"}
• {"criterion_text":"- Patients unable to complete the follow-up required by the study"}
• {"criterion_text":"- Patients under tutorship or curatorship"}
• {"criterion_text":"- Patient deprived of liberty by a judicial or administrative decision"}
• {"criterion_text":"- Absolute contraindications to IVIg: selective IgA deficiency, known thrombophilia, patients suffering from type I or II hyperprolinaemia, hypersensitivity to human immunoglobulins"}
• {"criterion_text":"- Absolute contraindications to cyclophosphamide: yellow fever vaccination within three months of inclusion, acute urinary tract infection, acute bone marrow failure"}
• {"criterion_text":"- More than two courses of intravenous Immunoglobulins administered in the 3 months prior to recruitment"}
• {"criterion_text":"- Other concomitant immunotherapy"}
• {"criterion_text":"- Other causes of immunodepression (acquired or congenital)"}
• {"criterion_text":"- Treatment with checkpoint inhibitors in progress or completed less than 3 months previously"}
• {"criterion_text":"- Women of childbearing age without effective contraception, pregnant or breastfeeding"}
• {"criterion_text":"- History of psychiatric or general illness that may contraindicate treatment"}

Primary endpoints

• {"endpoint_text":"- Percentage of patients with clinical improvement on the Overall Neuropathy Limitations Scale (ONLS) at 3 months","definition_or_measurement_approach":"Clinical improvement measured using the Overall Neuropathy Limitations Scale (ONLS) assessed at 3 months."}

Secondary endpoints

• {"endpoint_text":"- Percentage of patients with clinical improvement on the ONLS scale at 3 and 6 months","definition_or_measurement_approach":"Clinical improvement measured by ONLS at 3 months and 6 months."}
• {"endpoint_text":"- Percentage of patients with improvement of the ataxic component on the Score of Ataxia scale at 3 and 6 months","definition_or_measurement_approach":"Improvement of the ataxic component measured by the Score of Ataxia at 3 months and 6 months."}
• {"endpoint_text":"- Percentage of patients with improvement in neuropathic pain on the Numeric Rating Scale (NRS) at 3 and 6 months","definition_or_measurement_approach":"Change in neuropathic pain measured by Numeric Rating Scale (NRS) at 3 months and 6 months."}
• {"endpoint_text":"- Percentage of patients with functional improvement on the modified Rankin Score (mRS) at 3 and 6 month","definition_or_measurement_approach":"Functional improvement measured by modified Rankin Score (mRS) at 3 and 6 months."}
• {"endpoint_text":"- Percentage of patients with functional improvement on the Barthel Index (BI) at 3 and 6 months","definition_or_measurement_approach":"Functional improvement measured by Barthel Index (BI) at 3 and 6 months."}
• {"endpoint_text":"- Percentage of patients alive and without tumour progression at 6 months","definition_or_measurement_approach":"Proportion of patients alive and without tumour progression assessed at 6 months."}
• {"endpoint_text":"- Tolerability of treatment will be assessed by the frequency and severity of expected and unexpected adverse events recorded during treatment.","definition_or_measurement_approach":"Tolerability assessed by recording frequency and severity of expected and unexpected adverse events during treatment."}

France

Earliest CTIS Part Ii Submission Date

01-02-2024

Latest Decision Or Authorization Date

23-04-2025

Processing Time Days

447

Number Of Sites

8

Number Of Participants

21

Primary sponsor

Full Name

Assistance Publique Hopitaux De Paris

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France