Study of a Treatment Driven by Early PET Response to a Treatment Not Monitored by Early PET in Patients With AA Stage 3-4 or 2B HL

Inclusion Criteria:

• Patient with a first diagnosis of classical Hodgkin lymphoma according to world healthorganization (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 beforeany 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)

Exclusion Criteria:

• Pregnant or lactating women

• Men and women of childbearing potential not practicing an adequate method ofcontraception during the study treatment and at least 3 months after the last studydrug administration

• Any history of cancer or cancer treatment during the last 5 years with the exceptionof non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma

• Uncontrolled infectious disease, including active HBV (hepatitis B virus) infectiondefined by either detection of HBs Antigen or presence of anti HBs antibody withoutdetectable anti HBc antibody.

• HIV (Human immunodeficiency virus), HCV (hepatitis C virus) or HTLV (HumanT-lymphotropic virus) serology positivity

• Abnormal liver (bilirubin > 2,5 N) function unless abnormalities are due to AHL 2011Protocol 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 toHodgkin lymphoma

• Leukopenia < 2 G/l or thrombopenia <100 G/l unless abnormalities are due to Hodgkinlymphoma

• Severe cardio-pulmonary, or metabolic disease interfering with normal application ofprotocol 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 treatmentbeginning

• Incapable person