Evaluation of the Relationship Between Therapeutical Antibody Exposure and Tumor VOLUME in Patients Treated for Conventional HODgkin's Lymphoma
- Conditions
- Refractory Hodgkin LymphomaMedDRA version: 20.0Level: HLGTClassification code 10025319Term: Lymphomas Hodgkin's diseaseSystem Organ Class: 10005329 - Blood and lymphatic system disordersTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2020-001856-16-FR
- Lead Sponsor
- Rennes University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 50
- More than 18 years old
- Patient for whom treatment with anti-PD-1 antibodies (nivolumab or pembrolizumab) is administered as monotherapy for relapsed or refractory classical Hodgkin's lymphoma within the scope of the WMA
- Patient for whom a PET/CT scan for evaluation of TMTV is available within 30 days prior to the first dose of treatment without intercurrent antitumor therapy between the last PET-CT and the start of anti-PD1 therapy
- Signed consent form
- Patient with a Health insurance
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 50
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
- Persons of full age subject to legal protection (safeguard of justice, guardianship, trusteeship), persons deprived of their liberty, pregnant or breastfeeding women, minors, persons unable to give their consent
- Patient with a contraindication to treatment with OPDIVO or KEYTRUDA
- Patient treated with anti-PD1 in combination with other antitumor therapy
- Patient included in another interventional clinical study
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