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This study is a multicentric phase II open-label trial consisting of 6 cycles Nivolumab (2 weeks interval) followed by a PET-CT scan. The treatment will be allocated according to PET and CT scan responses. :
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | Induction treatment :Nivolumab will be given alone at 240 mg flat dose every 2 weeks (i.e. one cycle) Patients will be assessed after 3 months of therapy (after 6 injections of Nivolumab) Consolidation treatment: It depends on the induction evaluation by PET-CT and CT-scan (Lugano 2014 criteria) :
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nivolumab | Drug | 240 mg |
| |
| Vinblastin |
| Measure | Description | Time Frame |
|---|---|---|
| Complete Metabolic Response (CMR) rate (Deauville scale 1-3) at the end of treatment | by the Lugano classification 2014 | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Quantity of drug taken | 12 months | |
| Number of Serious Adverse Event | 12 months | |
| Progression-free survival (PFS) |
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Inclusion Criteria:
Exclusion Criteria:
Contra-indication to Nivolumab and /or Vinblastin
Subjects with active interstitial pneumonitis
Subjects with active infectious disease
Subjects with active, known or suspected autoimmune disease. Are permitted to enroll: subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger.
Any serious active disease, severe cardio-pulmonary, or metabolic disease interfering with normal application of protocol treatment (according to the investigator's decision)
Any of the following abnormal laboratory values (unless due to underlying HL) :
Any history of cancer evolution requiring therapy during the last 3 years with the exception of non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma. Patients previously diagnosed with prostate cancer are eligible if :
Uncontrolled diabetes mellitus leading to impossibility to perform PET scan
Treatment with any investigational drug within 30 days before planned first cycle of chemotherapy and during the study
Adult person under legal protection
Adult person unable to provide informed consent because of intellectual impairment, any serious medical condition, laboratory abnormality or psychiatric illness
Subjects with know Human Immunodeficiency Virus (HIV) positivity
Subjects with known active hepatitis B (HB) infection (positive Ag HB s or positive DNA polymerase chain reaction (PCR) or positive antibody anti-HB c with lack of antibody against HBs) or active hepatitis C infection (patients with positive HCV serology are eligible only if PCR is negative for known hepatitis C virus (HCV RNA)
Subjects with a condition requiring systemic treatment with either corticosteroids (> 10mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration except for adrenal replacement steroid doses > 10 mg daily prednisone equivalent in the absence of active autoimmune disease.
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| Name | Affiliation | Role |
|---|---|---|
| Vincent RIBRAG | Institut Gustave Roussy Cancer, Villejuif, France - LYSA | Study Chair |
| Julien LAZAROVICI | Institut Gustave Roussy Cancer, Villejuif, France - LYSA | Study Chair |
| Marc ANDRE | CHU Dinant Godinne, UCL Namur, Yvoir - Belgium - LYSA | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ZNA Stuivenberg | Antwerp | Belgium | ||||
| Az Sint Jan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42206423 | Derived | Lazarovici J, Amorim S, Bouabdallah K, Fournier M, Guidez S, Molina L, Morschhauser F, Delapierre B, Gastinne T, Laribi K, Launay V, Slama B, Belmecheri N, Casasnovas RO, Corby A, Durot E, Feugier P, Nicolas-Virelizie E, Sibon D, Berriolo-Riedinger A, Edeline V, Borght TV, Damotte D, Traverse-Glehen A, Ribrag V, Andre M. Nivolumab with or without vinblastine for first-line treatment of elderly patients with Hodgkin lymphoma and coexisting medical conditions: the Niviniho phase II Lysa study. Haematologica. 2026 May 28. doi: 10.3324/haematol.2025.300166. Online ahead of print. |
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| Drug |
6mg/m² |
|
| 5 years |
| Event-free survival (EFS) | 5 years |
| Overall survival (OS) | 5 years |
| Complete Metabolic Response (CMR) rate | by the Lugano classification 2014 at the end of induction treatment | 3 months |
| Bruges |
| Belgium |
| Clinique Universitaire Saint LUC | Brussels | Belgium |
| Institut Jules Bordet | Brussels | Belgium |
| Hopital Jolimont | Haine-Saint-Paul | Belgium |
| Az Groeninge | Kortrijk | Belgium |
| CHU de Liege | Liège | Belgium |
| CHU Dinant Godinne | Yvoir | Belgium |
| CHU UCL Namur | Yvoir | Belgium |
| CHU d'Amiens | Amiens | France |
| CH d'Avignon - Hôpital Henri Duffaut | Avignon | France |
| CH Côte Basque | Bayonne | France |
| CHU de Besançon - Hôpital Jean Minjoz | Besançon | France |
| Institut Bergonié - Bordeaux | Bordeaux | France |
| Institut d'Hématologie de Basse Normandie - CHU Côte de Nacre | Caen | France |
| CH Métropole Savoie | Chambéry | France |
| CHU de Clermont Ferrand | Clermont-Ferrand | France |
| CH Sud Francilien de Corbeil | Corbeil-Essonnes | France |
| APHP-Hôpital Henri Mondor | Créteil | France |
| CHU de Dijon - Hôpital le Bocage | Dijon | France |
| CHU de Grenoble | Grenoble | France |
| CHD de Vendée | La Roche-sur-Yon | France |
| CH La Rochelle | La Rochelle | France |
| CH du Mans | Le Mans | France |
| CH Saint Vincent de Paul | Lille | France |
| CHRU de LILLE - Claude Huriez | Lille | France |
| CHU de Limoges | Limoges | France |
| Centre Leon Berard | Lyon | France |
| Institut Paoli Calmette | Marseille | France |
| CHRU de Metz-Thionville | Metz | France |
| CHU de Montpellier - Saint Eloi | Montpellier | France |
| CHU de Nantes - Hôtel Dieu | Nantes | France |
| CHU de Nîmes - Caremeau | Nîmes | France |
| APHP - Hopital Necker | Paris | France |
| APHP - Hôpital de la Pitié Salpetrière | Paris | France |
| APHP - Hôpital Saint Louis | Paris | France |
| Centre François Magendie - Hôpital du Haut Lévêque | Pessac | France |
| CHU Lyon Sud | Pierre-Bénite | France |
| CHU de Poitiers - Hôpital de La Milétrie | Poitiers | France |
| Ch Rene Dubos | Pontoise | France |
| Centre Hospitalier Annecy-Genevois - Site d'Annecy | Pringy | France |
| CHU Robert Debré | Reims | France |
| CHU de Rennes - Hôpital Pontchaillou | Rennes | France |
| CH de Roubaix | Roubaix | France |
| Centre Henri Becquerel | Rouen | France |
| CH de Saint Brieuc | Saint-Brieuc | France |
| CHRU de Strasbourg | Strasbourg | 67100 | France |
| IUCT Toulouse | Toulouse | France |
| CHU Bretonneau | Tours | France |
| CHU Brabois | Vandœuvre-lès-Nancy | France |
| Institut Gustave Roussy | Villejuif | France |
| ID | Term |
|---|---|
| D006689 | Hodgkin Disease |
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| D014747 | Vinblastine |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
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