Clinical trial NCT00575406: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diffuse Large B-Cell Lymphoma
Lead sponsor: Arbeitsgemeinschaft medikamentoese Tumortherapie
Sponsor class: OTHER
First posted: 2007-12-18
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed, CD20 positive, diffuse large B-cell lymphoma (DLCL)
* measurable disease according to international criteria
* male or female
* age 18 years and above
* written informed consent

Exclusion Criteria:

* myocardial infarction within 6 months prior to study entry
* cardiac insufficiency NYHA grade 3 or 4
* previous treatment with chemotherapy or radiotherapy
* CNS involvement of the disease
* positive for HIV
* WHO Performance Index 3 or 4
* secondary malignoma
* concurrent disease that prohibits chemotherapy
* known hypersensitivity towards the study interventions or their constituents
* neutropenia or thrombopenia

Primary outcomes:
measure: Reduction of cardiotoxicity in the R-COMP arm versus R-CHOP
timeFrame: Study duration
Secondary outcomes:
measure: Significance of serial NT-proBNP measurements for determination of anthracycline-dependent cardiotoxicity
timeFrame: Study Duration
measure: Feasibility of evaluation with Haematopoietic Cell Transplantation Comorbidity Index (HCT-CI)
timeFrame: Study duration
measure: Rate of Complete Responses
timeFrame: At end of treatment
measure: Difference in Overall Survival at 3 and 5 yrs
timeFrame: 5 years
measure: Difference in Event-free Survival at 3 and 5 yrs
timeFrame: 5 years
measure: Difference in Progression-free Survival at 3 and 5 yrs
timeFrame: 5 years
measure: Difference in cause-specific death
timeFrame: 5 years
Other outcomes:
Locations:
city: Feldkirch
country: Austria
facility: Landeskrankenhaus Feldkirch
city: Innsbruck
country: Austria
facility: Universitaetsklinik Innsbruck/ Klinik für Innere Medizin
city: Leoben
country: Austria
facility: A.ö. Landeskrankenhaus Leoben
city: Linz
country: Austria
facility: Krankenhaus d. Barmherzigen Schwestern Linz
city: Linz
country: Austria
facility: Krankenhaus der Elisabethinen Linz
city: Linz
country: Austria
facility: Krankenhaus der Stadt Linz
city: Salzburg
country: Austria
facility: Universitaetsklinik f. Innere Medizin III
city: Vienna
country: Austria
facility: AKH Wien / Haematologie u. Haemostaseologie
city: Vienna
country: Austria
facility: Hanusch Krankenhaus
city: Wels
country: Austria
facility: Klinikum Kreuzschwestern Wels GmbH
Study officials:
affiliation: AKh Linz
name: Michael A Fridrik, MD
role: PRINCIPAL_INVESTIGATOR
References: