Actively Recruiting
Early Immunotherapy with Intravenous Immunoglobulin, Cyclophosphamide and Methylprednisolone in Patients with Anti-Hu-associated Paraneoplastic Sensory Neuronopathy
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-02-17
21
Participants Needed
1
Research Sites
176 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Early Immunotherapy with Intravenous Immunoglobulin, Cyclophosphamide and Methylprednisolone in Patients with Anti-Hu-associated Paraneoplastic Sensory Neuronopathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 218 years or older
- Diagnosis of "possible" sensory neuronopathy with an ONLS score of 1 or higher
- Dominant sensory ataxia symptoms, allowing minor impacts from central nervous system or neuromuscular junction damage
- Positive anti-Hu antibodies in blood and/or cerebrospinal fluid
- Outpatient status with modified Rankin Score of 2 or 3
- Neurological symptoms started less than 3 months ago
- Provided free, informed, written, and signed consent
- Affiliated with a social security or beneficiary scheme (excluding AME)
You will not qualify if you...
- Known allergies to study treatments, their metabolites, or excipients
- Absolute contraindications to IVIG, including selective IgA deficiency, thrombophilia, type I or II hyperprolinemia, or hypersensitivity to human immunoglobulins
- Absolute contraindications to cyclophosphamide, including recent yellow fever vaccination, acute urinary infection, hemorrhagic cystitis, urinary obstruction, or acute bone marrow failure
- Contraindications to methylprednisolone such as recent live vaccines or active infections (hepatitis, herpes, chickenpox, shingles)
- More than two IVIG courses in the 3 months before enrollment
- Receiving other immunotherapy or having other causes of immunosuppression
- Treatment with checkpoint inhibitors within the past 3 months
- Not using effective contraception
- Pregnant or breastfeeding women
- History of psychiatric or general illnesses contraindicating treatment
- Unable to complete required follow-up
- Under guardianship, curatorship, or deprived of liberty by judicial or administrative decision
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Hôpital Pitié-Salpêtrière
Paris, France, 75013
Actively Recruiting
Research Team
D
Dimitri Psimaras, MD
CONTACT
A
Alice LEPRINCE-LAURENGE, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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