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
Inclusion Criteria
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