Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Centre Hospitalier Universitaire Dijon
With
The Lymphoma Study Association
Age
16–60
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Patient with a first diagnosis of classical Hodgkin lymphoma according to world health organization (WHO) criteria excluding nodular lymphocyte predominant subtype
Age of 16 to 60 years
No previous treatment for Hodgkin lymphoma
Ann Arbor stages:
IIB with mediastinum/thorax ≥0.33 or extra nodal localization III IV
Baseline 18-FDG PET scan (PET0)(F-FDG Positon Emission Tomography) performed before any treatment with at least one hypermetabolic lesion
Eastern Cooperative Oncology Group (ECOG) performance status \< 3
With a minimum life expectancy of 3 months
Having previously signed a written informed consent
The patient must be covered by a social security system (in France)
You may not be if
Pregnant or lactating women
Men and women of childbearing potential not practicing an adequate method of contraception during the study treatment and at least 3 months after the last study drug administration
Any history of cancer or cancer treatment during the last 5 years with the exception of non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma
Uncontrolled infectious disease, including active HBV (hepatitis B virus) infection defined by either detection of HBs Antigen or presence of anti HBs antibody without detectable anti HBc antibody.
HIV (Human immunodeficiency virus), HCV (hepatitis C virus) or HTLV (Human T-lymphotropic virus) serology positivity
Abnormal liver (bilirubin \> 2,5 N) function unless abnormalities are due to AHL 2011 Protocol Version n°1.2\_ 09/02/11\_approved on March 11, 2011 EudraCT n°2010-022844-19 4 / 73 Hodgkin lymphoma
Abnormal renal (Creatinin \> 150 μmol/L) function unless abnormalities are due to Hodgkin lymphoma
Leukopenia \< 2 G/l or thrombopenia \<100 G/l unless abnormalities are due to Hodgkin lymphoma
Severe cardio-pulmonary, or metabolic disease interfering with normal application of protocol treatment:
Left Ejection Ventricular Fraction \<50%
Respiratory insufficiency prohibiting bleomycin use
Uncontrolled diabetes mellitus leading to impossibility to perform PET scan
Impossibility to perform a baseline PET (PET0) before randomization and treatment beginning
