Early Immunotherapy with Intravenous Immunoglobulin, Cyclophosphamide and Methylprednisolone in Patients with Anti-Hu-associated Paraneoplastic Sensory Neuronopathy

NCT06373211 · tracked via the Priya Life Science France tracker

Sponsor

Assistance Publique - Hôpitaux de Paris

Phase

Phase 2

Started

2025-01-10

Last updated

2025-02-17

Condition(s) studied

Paraneoplastic Sensory Neuronopathy

Investigational drug(s) / intervention(s)

Immunoglobulins IV (CLAYRIG) →Cyclophosphamide IV →Methylprednisolone IV →

Immunoglobulins IV (CLAYRIG): Patients will be treated with cycles of : \- Intravenous (IV) immunoglobulins: 2 g/kg per cycle, over 3 to 5 days (D1 to D3 or D5). Cycles will be administered every 4 weeks for a total of 3 first cycles

Cyclophosphamide IV: Patients will be treated with cycles of : \- Cyclophosphamide IV: 1 g on the first day (D1). Cycles will be administered every 4 weeks for a total of 6 cycles

Methylprednisolone IV: Patients will be treated with cycles of : Methylprednisolone IV: 1 g/day for 3 days (D1 to D3). Cycles will be administered every 4 weeks for a total of 6 cycles

Study summary

Paraneoplastic Neurological Syndromes are rare autoimmune complications linked to the presence of systemic cancer. Despite their autoimmune origin, they have historically shown little response to immunotherapy. The reason for this failure is probably related to too late administration of immunotherapy, at a stage where the inflammation has already disappeared and irreversible neuronal loss has occurred. The protocol focuses on patients with anti-Hu antibody sensory neuronopathy. This single arm trial consists of an early immunotherapy combining Intravenous Immunoglobulin (IVIG) for 3 months, cyclophosphamide and methylprednisolone for 6 months, at the rate of 1 cycle per month. The percentage of patients with clinical improvement will be evaluated (ONLS) at 3 months. The tolerance of the treatment will also be evaluated as well as other functional scales at 3 and 6 months.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Age ≥ 18 years old * "Possible" sensory neuronopathy according to the criteria of Camdessanché et al. \[2\] with ONLS score ≥ 1 * Dominant picture of sensory ataxia (damage to the central nervous system and/or the neuromuscular junction is allowed, provided that it has a minor impact on the patient's disability) * Positive anti-Hu antibodies in blood and/or cerebrospinal fluid * Outpatient (modified Rankin Score (mRS) 2 or 3) * Onset of neurological symptoms less than 3 months ago * Free, informed, written and signed consent * Affiliation to a social security or beneficiary scheme (except AME) Exclusion Criteria: * Known hypersensitivity to one of the treatments under study, to their metabolites, or to one of the excipients * Absolute contraindications to IVIg: selective IgA deficiency, known thrombophilia, patients suffering from type I or II hyperprolinemia, hypersensitivity to human immunoglobulins * Absolute contraindications to cyclophosphamide: vaccination against yellow fever in the 3 months preceding inclusion, acute urinary infection, pre-existing hemorrhagic cystitis, urinary tract obstruction, acute bone marrow failure * Contraindication to methylprednisolone: live vaccines, or live attenuated vaccines within 3 months, infectious state or evolving virus (hepatitis, herpes, chickenpox, shingles) * More than two courses of IVIg administered within 3 months before recruitment * Other concomitant immunotherapy * Other cause of immunosuppression (acquired or congenital) * Treatment with checkpoint inhibitors in progress or completed less than 3 months previously * Woman or man without effective contraception * Pregnant or breastfeeding woman * History of psychiatric or general illnesses that may contraindicate treatment * Patients unable to complete the follow-up required by the study * Patients under guardianship or curatorship * Patient deprived of liberty by a judicial or administrative decision

Primary outcome measure(s)

Percentage of patients with clinical improvement on the ONLS (Overall Neuropathy Limitations Scale) at 3 months — At 3 months

Trial sites (1)

Facility	City	Region	Status
Hôpital Pitié-Salpêtrière	Paris	France	Recruiting

More Assistance Publique - Hôpitaux de Paris trials in France

Fusion Ultrasound for Diagnosis and Monitoring of Endometriosis Lesions Active, not recruiting

neonAtal motoR paTtErn autoMatIc analySis Recruiting

Characterisation of Intestinal Microbiota of Patients With Spondyloarthritis or Rheumatoid Arthritis Recruiting

Effect of Adding Vasopressin on Cardiac Output, Blood Pressure, Diuresis, and Tissue Perfusion Indices in Patients With Septic Shock Starting soon

Efficacy of Methylprednisolone Pulses in Neuroendocrine Celles Hyperplasia of Infancy : An Early Phase Study Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06373211 on ClinicalTrials.gov ↗ ← All trials in France