MedDataX Logo

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

NCT ID: NCT00575406

Last Updated: 2013-08-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2012-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diffuse Large B-Cell Lymphoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

R-CHOP

Treatment with Rituximab, Cyclophosphamide, Doxorubicin, Vincristin and Prednisolone

Group Type ACTIVE_COMPARATOR

Rituximab

Intervention Type DRUG

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

Cyclophosphamide

Intervention Type DRUG

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

Doxorubicin

Intervention Type DRUG

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

Vincristin

Intervention Type DRUG

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

Prednisolone

Intervention Type DRUG

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

R-COMP

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

Group Type EXPERIMENTAL

Rituximab

Intervention Type DRUG

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

Cyclophosphamide

Intervention Type DRUG

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

liposomal Doxorubicin

Intervention Type DRUG

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

Vincristin

Intervention Type DRUG

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

Prednisolone

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Rituximab

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

Intervention Type DRUG

Cyclophosphamide

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

Intervention Type DRUG

Doxorubicin

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

Intervention Type DRUG

liposomal Doxorubicin

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

Intervention Type DRUG

Vincristin

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

Intervention Type DRUG

Prednisolone

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

MabThera Cytoxan Adriamycin Myocet Oncovin

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Arbeitsgemeinschaft medikamentoese Tumortherapie

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Michael A Fridrik, MD

Role: PRINCIPAL_INVESTIGATOR

AKh Linz

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Landeskrankenhaus Feldkirch

Feldkirch, , Austria

Site Status

Universitaetsklinik Innsbruck/ Klinik für Innere Medizin

Innsbruck, , Austria

Site Status

A.ö. Landeskrankenhaus Leoben

Leoben, , Austria

Site Status

Krankenhaus d. Barmherzigen Schwestern Linz

Linz, , Austria

Site Status

Krankenhaus der Elisabethinen Linz

Linz, , Austria

Site Status

Krankenhaus der Stadt Linz

Linz, , Austria

Site Status

Universitaetsklinik f. Innere Medizin III

Salzburg, , Austria

Site Status

AKH Wien / Haematologie u. Haemostaseologie

Vienna, , Austria

Site Status

Hanusch Krankenhaus

Vienna, , Austria

Site Status

Klinikum Kreuzschwestern Wels GmbH

Wels, , Austria

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Austria

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

EudraCT 2007-004970-24

Identifier Type: -

Identifier Source: secondary_id

NHL-14

Identifier Type: -

Identifier Source: org_study_id