A study of nivolumab alone, or in combination with vinblastin in patients aged 61 years and older, with Hodgkin Lymphoma

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 64

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

- 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 < 30 mL/min (MDRD formula)
b. AST or ALT > 2.5 times the upper limit of normal (ULN)
c. Serum total bilirubin > 30µmol/L
d. Neutrophils<1G/L or Platelets<50G/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 :
a. 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,
b. They had definitive curative therapy (ie, prostatectomy or radiotherapy) = 2 years before Day 1 of Cycle 1,
c. 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
- 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 unabled to provide informed consent because of intellectual impairment, any serious medical condition, laboratory abnormality or psychiatric illness
- Documented infection with HIV
- Subjects with known active hepatitis B infection (positive Ag HBs or positive DNA PCR or positive antibody anti-HBc with lack of antibody against HBs) or active hepatitis C infection (patients with positive HCV serology are eligible only if PCR is negative forfor known HCV RNA)
- Subjects with a condition requiring systemic treatment with either corticosteroids (> 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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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