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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Rigshospitalet
Copenhagen, Denmark
Freedom from treatment failure
Time frame: 9 years after first patient in (FPI)
response at the end of therapy
Time frame: 9 years after FPI
Progression-free survival
Time frame: 9 years after FPI
Overall survival
Time frame: 9 years after FPI
Acute toxicity
* Hematological toxicity (blood cell count) can be significant especially for patients who will receive BEACOPPesc . * Bleomycine interstitial pneumonitis has been frequently reported and requires the immediate stop of further bleomycine administration. * Rarely, procarbazine allergy and intolerance has been reported. * Nausea \& vomiting due to cyclophosphamide, doxorubicin, dacarbazine and procarbazine may be significant. * Total reversible alopecia occurs in most cases. * Escalated BEACOPP-related toxic deaths have been reported but do not exceed those observed with standard ABVD.
Time frame: 9 years after FPI
Long-term toxicity in terms of second malignancies, cardiovascular and pulmonary events
Time frame: 9 years after FPI
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