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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-506942-22-01 | Other Identifier | CTIS |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early immunotherapy | Experimental | Early immunotherapy with intravenous immunoglobulin, cyclophosphamide and methylprednisolone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immunoglobulins IV (CLAYRIG) | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with clinical improvement on the ONLS (Overall Neuropathy Limitations Scale) at 3 months | At 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with clinical improvement on the ONLS (Overall Neuropathy Limitations Scale) at 3 and 6 months | At 3 months and at 6 months | |
| Percentage of patients with improvement in the ataxic component on the Score of Ataxia scale at 3 and 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dimitri Psimaras, MD | Contact | +33 1 42 16 04 35 | dimitri.psimaras@aphp.fr | |
| Alice LEPRINCE-LAURENGE, MD | Contact | +33 1 42 16 03 86 | alice.laurenge@aphp.fr |
| Name | Affiliation | Role |
|---|---|---|
| Dimitri Psimaras, MD | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Pitié-Salpêtrière | Recruiting | Paris | 75013 | France |
The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor
Researchers who provide a methodologically sound proposal.
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| Cyclophosphamide IV | Drug | 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 | Drug | 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 |
|
| At 3 months and at 6 months |
| Percentage of patients with improvement in neuropathic pain on the Numeric Rating Scale (NRS) at 3 and 6 months | At 3 months and at 6 months |
| Percentage of patients with functional improvement on the modified Rankin Score (mRS) at 3 and 6 months | At 3 months and at 6 months |
| Percentage of patients with functional improvement on the Barthel Index (BI) at 3 and 6 months | At 3 months and at 6 months |
| Percentage of patients alive and without tumor progression at 6 months | At 6 months |
| Tolerance to treatment | Will be assessed by the frequency and severity of expected and unexpected adverse effects recorded during treatment | Through study completion, a maximum of 36 months |
| ID | Term |
|---|---|
| D010257 | Paraneoplastic Syndromes |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D005719 | gamma-Globulins |
| ID | Term |
|---|---|
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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