NCT06373211 Early Immunotherapy with Intravenous Immunoglobulin, Cyclophosphamide and Methylprednisolone in Patients with Anti-Hu-associated Paraneoplastic Sensory Neuronopathy
| NCT ID | NCT06373211 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Paraneoplastic Sensory Neuronopathy |
| Study Type | INTERVENTIONAL |
| Enrollment | 21 participants |
| Start Date | 2025-01-10 |
| Primary Completion | 2028-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 21 participants in total. It began in 2025-01-10 with a primary completion date of 2028-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Dimitri Psimaras, MD
PRINCIPAL INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Frequently Asked Questions
Who can join the NCT06373211 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Paraneoplastic Sensory Neuronopathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06373211 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06373211 currently recruiting?
Yes, NCT06373211 is actively recruiting participants. Contact the research team at dimitri.psimaras@aphp.fr for enrollment information.
Where is the NCT06373211 trial being conducted?
This trial is being conducted at Paris, France.
Who is sponsoring the NCT06373211 clinical trial?
NCT06373211 is sponsored by Assistance Publique - Hôpitaux de Paris. The principal investigator is Dimitri Psimaras, MD at Assistance Publique - Hôpitaux de Paris. The trial plans to enroll 21 participants.