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Brief Title: Multicentre Study to Determine the Cardiotoxicity of R-CHOP Compared to R-COMP in Patients With Diffuse Large B-Cell Lymphoma
Official Title: Multicentre Study to Determine the Cardiotoxicity of R-CHOP (Rituximab, Cyclophosphamide, Doxorubicin, Vincristin and Prednisolone) Compared to R-COMP (Rituximab, Cyclophosphamide, Liposomal Doxorubicin, Vincristin and Prednisolone) in Patients With Diffuse Large B-Cell Lymphoma (NHL-14)
Study ID: NCT00575406
Brief Summary: Diffuse large B-cell lymphoma is the most prevalent subgroup within malignant lymphoma. Clinical benefit has been shown for the treatment with cyclophosphamide, doxorubicin, vincristin and prednisolone (CHOP regimen); this could be further improved recently by the addition of rituximab (R-CHOP), a monoclonal antibody. Improved response and overall survival rates make it necessary to evaluate late toxicities of the therapy regimens. Cardiotoxicity is a known risk factor of specific chemotherapies, with 7% patients being affected if doxorubicin cumulative doses are under 550mg/sqm. Retrospective data analyses indicate that this incidence of cardiotoxicity may be higher under combination chemotherapy. Liposomal doxorubicin has been shown to have lower cardiotoxic effects and at the same time equivalent or higher efficacy compared to conventional doxorubicin. The aim of this study is to evaluate alternative regimens for the treatment of diffuse large B-cell lymphoma, substituting liposomal doxorubicin (R-COMP) for conventional doxorubicin (R-CHOP).
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Landeskrankenhaus Feldkirch, Feldkirch, , Austria
Universitaetsklinik Innsbruck/ Klinik für Innere Medizin, Innsbruck, , Austria
A.ö. Landeskrankenhaus Leoben, Leoben, , Austria
Krankenhaus d. Barmherzigen Schwestern Linz, Linz, , Austria
Krankenhaus der Elisabethinen Linz, Linz, , Austria
Krankenhaus der Stadt Linz, Linz, , Austria
Universitaetsklinik f. Innere Medizin III, Salzburg, , Austria
AKH Wien / Haematologie u. Haemostaseologie, Vienna, , Austria
Hanusch Krankenhaus, Vienna, , Austria
Klinikum Kreuzschwestern Wels GmbH, Wels, , Austria
Name: Michael A Fridrik, MD
Affiliation: AKh Linz
Role: PRINCIPAL_INVESTIGATOR