Diffuse Large B-Cell Lymphoma Clinical Trial
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)
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).
n/a
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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