Multicentre Study to Determine the Cardiotoxicity of R-CHOP Compared to R-COMP in Patients With Diffuse Large B-Cell Lymphoma

Diffuse Large B-Cell Lymphoma Clinical Trial

— NHL-14  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00575406
• Other study ID #: NHL-14
• Secondary ID: EudraCT 2007-004
• Status: Completed
• Phase: Phase 2
• First received: December 17, 2007
• Last updated: August 29, 2013
• Start date: December 2007
• Est. completion date: January 2012

Study information

• Verified date: August 2013
• Source: Arbeitsgemeinschaft medikamentoese Tumortherapie
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Office for Safety in Health Care
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diffuse Large B-Cell Lymphoma
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse

Intervention

Drug:
• Rituximab
i.v., 375 mg/m2, d0 or d1 of each treatment cycle
• Cyclophosphamide
i.v., 750 mg/m2, d1 of each treatment cycle
• Doxorubicin
i.v., 50 mg/m2, d1 of each treatment cycle
• liposomal Doxorubicin
i.v., 50 mg/m2, d1 of each treatment cycle
• Vincristin
i.v., 2mg, d1 of each treatment cycle
• Prednisolone
p.o., 100mg, d1 - d5 of each treatment cycle

Locations

Country	Name	City	State
Austria	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

Sponsors (1)

Lead Sponsor	Collaborator
Arbeitsgemeinschaft medikamentoese Tumortherapie

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of cardiotoxicity in the R-COMP arm versus R-CHOP		Study duration	Yes
Secondary	Significance of serial NT-proBNP measurements for determination of anthracycline-dependent cardiotoxicity		Study Duration	Yes
Secondary	Feasibility of evaluation with Haematopoietic Cell Transplantation Comorbidity Index (HCT-CI)		Study duration	Yes
Secondary	Rate of Complete Responses		At end of treatment	No
Secondary	Difference in Overall Survival at 3 and 5 yrs		5 years	No
Secondary	Difference in Event-free Survival at 3 and 5 yrs		5 years	No
Secondary	Difference in Progression-free Survival at 3 and 5 yrs		5 years	No
Secondary	Difference in cause-specific death		5 years	No