patients aged 61 years and older, with classical Hodgkin lymphoma and coexisting medical conditions MedDRA version: 20.1 Level: LLT Classification code 10080208 Term: Classical Hodgkin lymphoma System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Opdivo
Product Name: Opdivo
Pharmaceutical Form: Solution for injection
INN or Proposed INN: NIVOLUMAB
CAS Number: 946414-94-4
Other descriptive name: NIVOLUMAB
Concentration unit: mg/ml m
Sponsors
LYSARC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Having a first diagnosis of classical Hodgkin lymphoma - Age 61 years or older - Unfit for polychemotherapy - No previous treatment for Hodgkin lymphoma - Ann Arbor stages: I-IV - Baseline 18-FDG PET-CT (PET0) performed before any treatment with at least one hypermetabolic lesion - A minimum life expectancy of 3 months Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 54
Exclusion 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 - 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 : a. Calculated creatinine clearance 2.5 times the upper limit of normal (ULN) c. Serum total bilirubin > 30µmol/L d. Neutrophils 10 mg 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the Complete Metabolic Response (CMR) rate by the Lugano classification 2014 at the end of treatment.;Secondary Objective: • To assess the feasibility of the protocol, with adequate protocol adherence (adequate dose without excessive delay) • To assess the safety profile of Nivolumab alone or combined with Vinblastin including immediate toxicities and non tumor events • To assess progression-free survival (PFS), event-free survival (EFS), and overall survival (OS) • To assess Complete Metabolic Response (CMR) rate by the Lugano classification 2014 at the end of induction treatment • To perform a geriatric assessment program (G8, CIRS-G);Primary end point(s): To assess the Complete Metabolic Response (CMR) rate by the Lugano classification 2014;Timepoint(s) of evaluation of this end point: at the end of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Feasibility - Progression free survival - Event free Survival - Overall survival - Complete response rates at end of induction treatment - Safety endpoints - Geriatric assessment;Timepoint(s) of evaluation of this end point: - Feasibility - Progression free survival: from first nivolumab dose into the study to the first observation of documented disease progression/relapse or death due to any cause - Event free Survival: from the date of first nivolumab dose to the date of first documented disease progression/relapse, initiation of new anti-lymphoma therapy or death from any cause. - Overall survival: from date of first nivolumab dose into the study to the date of death from any cause - Complete response rates at end of induction treatment: at end of induction treatment - Safety endpoints: throughout the study - Geriatric assessment: at baseline | — |
Countries
Belgium, France
Contacts
Public ContactProject Manager Chloé Gourc Berthod
LYSARC
Outcome results
None listed