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

August 29, 2013 updated by: Arbeitsgemeinschaft medikamentoese Tumortherapie

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)

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

94

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Feldkirch, Austria, A-6806
        • Landeskrankenhaus Feldkirch
      • Innsbruck, Austria, A-6020
        • Universitaetsklinik Innsbruck/ Klinik für Innere Medizin
      • Leoben, Austria, A-8700
        • A.ö. Landeskrankenhaus Leoben
      • Linz, Austria, A-4010
        • Krankenhaus d. Barmherzigen Schwestern Linz
      • Linz, Austria, A-4010
        • Krankenhaus der Elisabethinen Linz
      • Linz, Austria, A-4020
        • Krankenhaus der Stadt Linz
      • Salzburg, Austria, A-5020
        • Universitaetsklinik f. Innere Medizin III
      • Vienna, Austria, A-1090
        • AKH Wien / Haematologie u. Haemostaseologie
      • Vienna, Austria, A-1140
        • Hanusch Krankenhaus
      • Wels, Austria, A-4600
        • Klinikum Kreuzschwestern Wels GmbH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: R-CHOP
Treatment with Rituximab, Cyclophosphamide, Doxorubicin, Vincristin and Prednisolone
Drug: Rituximab
i.v., 375 mg/m2, d0 or d1 of each treatment cycle
Other Names:
  • MabThera
Drug: Cyclophosphamide
i.v., 750 mg/m2, d1 of each treatment cycle
Other Names:
  • Cytoxan
Drug: Doxorubicin
i.v., 50 mg/m2, d1 of each treatment cycle
Other Names:
  • Adriamycin
Drug: Vincristin
i.v., 2mg, d1 of each treatment cycle
Other Names:
  • Oncovin
Drug: Prednisolone
p.o., 100mg, d1 - d5 of each treatment cycle
Experimental: R-COMP
Treatment with Rituximab, Cyclophosphamide, liposomal Doxorubicin, Vincristin and Prednisolone
Drug: Rituximab
i.v., 375 mg/m2, d0 or d1 of each treatment cycle
Other Names:
  • MabThera
Drug: Cyclophosphamide
i.v., 750 mg/m2, d1 of each treatment cycle
Other Names:
  • Cytoxan
Drug: Vincristin
i.v., 2mg, d1 of each treatment cycle
Other Names:
  • Oncovin
Drug: Prednisolone
p.o., 100mg, d1 - d5 of each treatment cycle
Drug: liposomal Doxorubicin
i.v., 50 mg/m2, d1 of each treatment cycle
Other Names:
  • Myocet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reduction of cardiotoxicity in the R-COMP arm versus R-CHOP
Time Frame: Study duration
Study duration

Secondary Outcome Measures

Outcome Measure
Time Frame
Significance of serial NT-proBNP measurements for determination of anthracycline-dependent cardiotoxicity
Time Frame: Study Duration
Study Duration
Feasibility of evaluation with Haematopoietic Cell Transplantation Comorbidity Index (HCT-CI)
Time Frame: Study duration
Study duration
Rate of Complete Responses
Time Frame: At end of treatment
At end of treatment
Difference in Overall Survival at 3 and 5 yrs
Time Frame: 5 years
5 years
Difference in Event-free Survival at 3 and 5 yrs
Time Frame: 5 years
5 years
Difference in Progression-free Survival at 3 and 5 yrs
Time Frame: 5 years
5 years
Difference in cause-specific death
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Arbeitsgemeinschaft medikamentoese Tumortherapie

Investigators

  • Principal Investigator: Michael A Fridrik, MD, AKh Linz

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

December 17, 2007

First Submitted That Met QC Criteria

December 17, 2007

First Posted (Estimate)

December 18, 2007

Study Record Updates

Last Update Posted (Estimate)

August 30, 2013

Last Update Submitted That Met QC Criteria

August 29, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NHL-14
  • EudraCT 2007-004970-24

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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