Prospective, multicenter, Phase II trial designed to assess whether intensification of ABVD (dd-ABVD) is feasible and can improve the outcome of patients with early stage Hodgkin Lymphoma.
Dose-density has been shown to be an important factor for complete remission rate and longterm survival in lymphomas. The aims of this study were to find out whether intensification of ABVD (dd-ABVD) is feasible and can improve the outcome of patients with early stage Hodgkin Lymphoma. In view of emerging data on the role of early PET in defining prognosis in Hodgkin Lymphoma patients, the percentage of FDG-PET (fluorodeoxyglucose positron emission tomography) negativity after two cycle was chosen as the parameter to evaluate dd-ABVD activity.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
dose dense ABVD will be administered intravenously on day 1 and 8 every 21 days Chemotherapy regimen * Doxorubicin 25 mg/m2 i.v. day 1 and 8 * Bleomycin 10 mg/m2 i.v. day 1 and 8 * Vinblastine 6 mg/m2 i.v. day 1 and 8 * Dacarbazine 375 mg/m2 i.v. day 1 and 8 Granulocyte colony-stimulating factor (G-CSF): days 9 to 14
Feasibility
Proportion of patient with a dose intensity reduction (lower than 85% of planned dose)
Time frame: After 4 dd-ABVD cycles (12 weeks after starting treatment)
Activity
Percentage of FDG PET negativity after 2 dd-ABVD cycles will be considered as primary endpoints.
Time frame: After 2 dd-ABVD cycles (6 week after starting treatment)
Overall accuracy of each interim PET interpretation criteria after a minimum follow-up of three years
Concordance between pet results and patients prognosis
Time frame: After 3 years of follow-up
PFS
Progression free survival estimate (prognosis outcome)
Time frame: 2 years from the activation of therapy in the last patient enrolled onto the study.
OS
Overall survival estimate (prognosis outcome)
Time frame: 2 years from the activation of therapy in the last patient enrolled onto the study.
Toxicity
Proportion of early and late toxicities (G3/4 acute toxicities, secondary malignancies, cardiovascular and pulmonary events, infertility)
Time frame: 2 years from the activation of therapy in the last patient enrolled onto the study.
Predictive Value of each interim PET interpretation criteria after a minimum follow-up of three years
Concordance between pet results and patients prognosis
Time frame: After 3 years of follow-up
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