Randomized Phase III Study of a Treatment Driven by Early PET Response Compared to a Treatment Not Monitored by Early PET in Patients With Ann Arbor Stage III-IV or High Risk IIB Hodgkin Lymphoma
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
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- 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
- Incapable person