Multicentre Study to Determine the Cardiotoxicity of R-CHOP Compared to R-COMP in Patients With Diffuse Large B-Cell Lymphoma (NHL-14)

Arbeitsgemeinschaft medikamentoese Tumortherapie

Status and phase: Completed; Phase 2

Conditions: Diffuse Large B-Cell Lymphoma

Treatments: Drug: Cyclophosphamide; Drug: Prednisolone; Drug: Vincristin; Drug: Doxorubicin; Drug: Rituximab; Drug: liposomal Doxorubicin

Study type: Interventional

Funder types: Other

Identifiers

NCT00575406

EudraCT 2007-004970-24

NHL-14

Details and patient eligibility

About

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).

Enrollment: 94 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

94 participants in 2 patient groups

R-CHOP

Active Comparator group

Description:

Treatment with Rituximab, Cyclophosphamide, Doxorubicin, Vincristin and Prednisolone

Treatment:

Drug: Rituximab

Drug: Prednisolone

Drug: Doxorubicin

Drug: Vincristin

Drug: Cyclophosphamide

R-COMP

Experimental group

Description:

Treatment with Rituximab, Cyclophosphamide, liposomal Doxorubicin, Vincristin and Prednisolone

Treatment:

Drug: liposomal Doxorubicin

Drug: Rituximab

Drug: Prednisolone

Drug: Vincristin

Drug: Cyclophosphamide