Neoplasms

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Lymphoma

Hodgkin Disease

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

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Hodgkin Lymphoma

Antineoplastic Agents

All Drugs and Chemicals

Doxorubicin

Liposomal doxorubicin

Lenograstim

Bleomycin

Vinblastine

Dacarbazine

1 arm for all patients (dose dense ABVD on day 1 and 8 every 21 days)

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

dose dense ABVD

Armando Santoro, M.D.

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.

Dose-dense ABVD First Line Therapy in Early Stage Unfavorable Hodgkin's Lymphoma

Dose-dense ABVD as First Line Therapy in Early Stage Unfavorable Hodgkin's Lymphoma: a Phase II, Prospective, Multi-center Study

Proportion of patient with a dose intensity reduction (lower than 85% of planned dose)

Percentage of FDG PET negativity after 2 dd-ABVD cycles will be considered as primary endpoints.

Concordance between pet results and patients prognosis

Progression free survival estimate (prognosis outcome)

Overall survival estimate (prognosis outcome)

Proportion of early and late toxicities (G3/4 acute toxicities, secondary malignancies, cardiovascular and pulmonary events, infertility)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Dose-dense ABVD First Line Therapy in Early Stage Unfavorable Hodgkin's Lymphoma	NCT02247869	Hodgkin Lymphom...	dose dense ABVD	18 Years - 70 Years	Fondazione Italiana Linfomi - ETS
Dose-dense ABVD First Line Therapy in Early Stage Unfavorable Hodgkin's Lymphoma	NCT02247869	Hodgkin Lymphom...	dose dense ABVD	18 Years - 70 Years	Fondazione Italiana Linfomi - ETS

Spots Global Cancer Trial Database for dose dense abvd