Very Early FDG-PET/CT-response Adapted Therapy for Advanced Hodgkin Lymphoma (H11)

Very Early FDG-PET/CT-response Adapted Therapy for Advanced Stage Hodgkin Lymphoma, a Randomized Phase III Non-inferiority Study of the EORTC Lymphoma Group

The main objective of the trial is to show that doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD)-based response-adapted therapy for advanced-stage Hodgkin lymphoma, with treatment intensification (bleomycin, etoposide, adriamycin, cyclophosphamide, vincristine, procarbazine, and prednisone (BEACOPPesc) in case of a positive fluorodeoxyglucose (FDG) positron emission tomography (PET) computed tomography (CT) after one cycle of ABVD, has non-inferior efficacy compared with the intensive BEACOPPesc regimen. A second objective is to assess the prognostic value of FDG-PET/CT after one cycle of BEACOPPesc.

Inclusion criteria:

• Previously untreated, histologically proven classical Hodgkin lymphoma
• Clinical stages III/IV (Ann Arbor)
• Age 18-60
• WHO performance 0-2
• Adequate organ function
• Patients of childbearing/reproductive potential should use adequate birth control measures during the whole duration of study treatment.
• Written informed consent according to ICH/EU Good Clinical Practice, and national/local regulations

Exclusion criteria:

• Pregnancy or lactation
• Specific contraindications to BEACOPPesc therapy, including:
• Poorly controlled diabetes mellitus
• HIV infection,
• Chronic active hepatitis B and/or hepatitis C
• Concomitant or previous malignancies with the exception of basal cell skin tumors, adequately treated carcinoma in situ of the cervix and any cancer that has been in complete remission for >5 years
• Psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial