Study Of Nivolumab Alone, Or In Combination With Vinblastin In Patients With Classical Hodgkin Lymphoma
NCT ID: NCT03580408
Last Updated: 2022-08-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
64 participants
INTERVENTIONAL
2018-08-31
2021-08-12
Brief Summary
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* In case of CMR according to Lugano Classification (Cheson et al.2014, PET-CT based response), patients will receive 18 additional cycles of Nivolumab, according to CT-based response at Cycle 12.
* In case of Partial Metabolic Response (PMR) or No Metabolic Response(NMR), according to Lugano Classification (Cheson et al.2014, PET-CT based response) patients will receive 12 to 18 cycles of Nivolumab combined with Vinblastin according to CT-based response at Cycle 12.
* In case of progressive disease, according to Lugano Classification (Cheson et al.2014, PET-CT scan based response) patients will be considered in treatment failure.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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) :
* For patients achieving CMR according to Lugano Classification : treatment by nivolumab 240 mg every 2 weeks for 9 months.
* Patients who reach PMR and NMR after 3 months (according to Lugano Classification) will be treated by the Nivolumab+Vinblastin regimen every 2 weeks for 9 additional months: Vinblastin(6 mg/m2 (IV) + Nivolumab 240 mg (IV)
* In case of progressive disease , patients will be considered in treatment failure.
Nivolumab
240 mg
Vinblastin
6mg/m²
Interventions
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Nivolumab
240 mg
Vinblastin
6mg/m²
Eligibility Criteria
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Inclusion Criteria
* Age 61 years or older
* Unfit for poly chemotherapy because of co-morbidities evaluated by a Cumulative Illness Rating Scale (CIRS) score ≥6)
* No previous treatment for Hodgkin lymphoma
* Ann Arbor stages: I-IV
* Baseline 18-fluoro-2-deoxy-D-glucose (18F-FDG) PET-CT (PET0) performed before any treatment with at least one hypermetabolic lesion
* Eastern Cooperative Oncology Group (ECOG) performance status 0-3
* minimum life expectancy of 3 months
* covered by a social security system
* Men who are sexually active with women with childbearing potential must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug and for at least 7 months after the last drug administration.
Exclusion Criteria
* 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) :
1. Calculated creatinine clearance \< 30 mL/min (MDRD formula)
2. aspartate transaminase (AST) or alanine transaminase (ALT) \> 2.5 times the upper limit of normal (ULN)
3. Serum total bilirubin \> 30µmol/L
4. Neutrophils\<1 G/L or Platelets\<50 G/L, (unless related to bone infiltration by lymphoma)
* 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 :
1. Their disease was T1-T2a, N0, M0, with a Gleason score ≤ 7, and a prostate specific antigen (PSA) ≤ 10 ng/mL prior to initial therapy,
2. They had definitive curative therapy (ie, prostatectomy or radiotherapy) ≥ 2 years before Day 1 of Cycle 1,
3. At a minimum 2 years following therapy they had no clinical evidence of prostate cancer, and their PSA was undetectable if they underwent prostatectomy or \<1 ng/mL if they did not undergo prostatectomy.
* 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.
61 Years
ALL
No
Sponsors
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The Lymphoma Academic Research Organisation
OTHER
Responsible Party
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Principal Investigators
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Vincent RIBRAG
Role: STUDY_CHAIR
Institut Gustave Roussy Cancer, Villejuif, France - LYSA
Julien LAZAROVICI
Role: STUDY_CHAIR
Institut Gustave Roussy Cancer, Villejuif, France - LYSA
Marc ANDRE
Role: STUDY_CHAIR
CHU Dinant Godinne, UCL Namur, Yvoir - Belgium - LYSA
Locations
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ZNA Stuivenberg
Antwerp, , Belgium
Az Sint Jan
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, , France
IUCT Toulouse
Toulouse, , France
CHU Bretonneau
Tours, , France
CHU Brabois
Vandœuvre-lès-Nancy, , France
Institut Gustave Roussy
Villejuif, , France
Countries
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Other Identifiers
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NIVINIHO
Identifier Type: -
Identifier Source: org_study_id
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