EUCTR2017-001939-38-BE
Active, not recruiting
Phase 1
A prospective phase II study of nivolumab alone, or in combination with vinblastin in patients aged 61 years and older, with classical Hodgkin Lymphoma and coexisting medical conditions
YSARC0 sites64 target enrollmentMay 24, 2018
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- patients aged 61 years and older, with classical Hodgkin lymphoma and coexisting medical conditions
- Sponsor
- YSARC
- Enrollment
- 64
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
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)
Outcomes
Primary Outcomes
Not specified
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