Early immunotherapy for patients with anti-Hu-associated sensory neuronopathy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effects of early immunotherapy in patients diagnosed with anti-Hu-associated paraneoplastic sensory neuronopathy. The approach involves a combination of Intravenous Immunoglobulin (IVIG), cyclophosphamide, and methylprednisolone administered over a six-month period. The trial aims to evaluate the percentage of patients showing clinical improvement using the Overall Neuropathy Limitation Scale (ONLS) at three months, as well as assessing treatment tolerance and other functional scales at three and six months. The study targets patients who have experienced neurological symptoms for less than three months.

Why it matters

Who can join: the full rules

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

Where it's running

• Hôpital Pitié-Salpêtrière
  Paris, France Recruiting

Study contacts

• Principal investigator: Dimitri Psimaras, MD — Assistance Publique - Hôpitaux de Paris
• Study coordinator: Dimitri Psimaras, MD
• Email: dimitri.psimaras@aphp.fr
• Phone: +33 1 42 16 04 35

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.