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

NCT00575406 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2013-08-30

No results posted yet for this study

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).

Conditions

  • Diffuse Large B-Cell Lymphoma

Interventions

DRUG

Rituximab

i.v., 375 mg/m2, d0 or d1 of each treatment cycle

DRUG

Cyclophosphamide

i.v., 750 mg/m2, d1 of each treatment cycle

DRUG

Doxorubicin

i.v., 50 mg/m2, d1 of each treatment cycle

DRUG

liposomal Doxorubicin

i.v., 50 mg/m2, d1 of each treatment cycle

DRUG

Vincristin

i.v., 2mg, d1 of each treatment cycle

DRUG

Prednisolone

p.o., 100mg, d1 - d5 of each treatment cycle

Sponsors & Collaborators

  • Arbeitsgemeinschaft medikamentoese Tumortherapie

    lead OTHER

Principal Investigators

  • Michael A Fridrik, MD · AKh Linz

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-12-31
Primary Completion
2012-01-31
Completion
2012-01-31

Countries

  • Austria

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00575406 on ClinicalTrials.gov