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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
94
i.v., 375 mg/m2, d0 or d1 of each treatment cycle
i.v., 750 mg/m2, d1 of each treatment cycle
i.v., 50 mg/m2, d1 of each treatment cycle
i.v., 50 mg/m2, d1 of each treatment cycle
i.v., 2mg, d1 of each treatment cycle
p.o., 100mg, d1 - d5 of each treatment cycle
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
Reduction of cardiotoxicity in the R-COMP arm versus R-CHOP
Time frame: Study duration
Significance of serial NT-proBNP measurements for determination of anthracycline-dependent cardiotoxicity
Time frame: Study Duration
Feasibility of evaluation with Haematopoietic Cell Transplantation Comorbidity Index (HCT-CI)
Time frame: Study duration
Rate of Complete Responses
Time frame: At end of treatment
Difference in Overall Survival at 3 and 5 yrs
Time frame: 5 years
Difference in Event-free Survival at 3 and 5 yrs
Time frame: 5 years
Difference in Progression-free Survival at 3 and 5 yrs
Time frame: 5 years
Difference in cause-specific death
Time frame: 5 years
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