drugset / Trial / NCT01652261

Very Early FDG-PET/CT-response Adapted Therapy for Advanced Hodgkin Lymphoma (H11)

NCT01652261

RandomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2013-05
Primary completion
2014-10
Completion
2014-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Bleomycin Unknown
Subject Cyclophosphamide Other / unclassified
Subject Dacarbazine Small molecule
Subject Doxorubicin Other / unclassified
Subject Etoposide Small molecule
Subject Prednisone Other / unclassified
Subject Vinblastine Small molecule
Subject Vincristine Small molecule
Subject procarbazine Small molecule

Indications