NCT02247869

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Fondazione Italiana Linfomi - ETS · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Hodgkin Lymphoma

Interventions

Type	Name	Description
DRUG	dose dense ABVD	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

Timeline

• Start date: 2012-02-01
• Primary completion: 2015-06-01
• Completion: 2017-04-29
• First posted: 2014-09-25
• Last updated: 2018-02-09

Locations

37 sites across 1 country: Italy