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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 (NHL-14)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Arbeitsgemeinschaft medikamentoese Tumortherapie
ClinicalTrials.gov Identifier:
NCT00575406
First received: December 17, 2007
Last updated: August 29, 2013
Last verified: August 2013
  Purpose

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).


Condition Intervention Phase
Diffuse Large B-Cell Lymphoma
Drug: Rituximab
Drug: Cyclophosphamide
Drug: Doxorubicin
Drug: liposomal Doxorubicin
Drug: Vincristin
Drug: Prednisolone
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Arbeitsgemeinschaft medikamentoese Tumortherapie:

Primary Outcome Measures:
  • Reduction of cardiotoxicity in the R-COMP arm versus R-CHOP [ Time Frame: Study duration ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Significance of serial NT-proBNP measurements for determination of anthracycline-dependent cardiotoxicity [ Time Frame: Study Duration ] [ Designated as safety issue: Yes ]
  • Feasibility of evaluation with Haematopoietic Cell Transplantation Comorbidity Index (HCT-CI) [ Time Frame: Study duration ] [ Designated as safety issue: Yes ]
  • Rate of Complete Responses [ Time Frame: At end of treatment ] [ Designated as safety issue: No ]
  • Difference in Overall Survival at 3 and 5 yrs [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Difference in Event-free Survival at 3 and 5 yrs [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Difference in Progression-free Survival at 3 and 5 yrs [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Difference in cause-specific death [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Enrollment: 94
Study Start Date: December 2007
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: MabThera
Drug: Cyclophosphamide
i.v., 750 mg/m2, d1 of each treatment cycle
Other Name: Cytoxan
Drug: Doxorubicin
i.v., 50 mg/m2, d1 of each treatment cycle
Other Name: Adriamycin
Drug: Vincristin
i.v., 2mg, d1 of each treatment cycle
Other Name: 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 Name: MabThera
Drug: Cyclophosphamide
i.v., 750 mg/m2, d1 of each treatment cycle
Other Name: Cytoxan
Drug: liposomal Doxorubicin
i.v., 50 mg/m2, d1 of each treatment cycle
Other Name: Myocet
Drug: Vincristin
i.v., 2mg, d1 of each treatment cycle
Other Name: Oncovin
Drug: Prednisolone
p.o., 100mg, d1 - d5 of each treatment cycle

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00575406

Locations
Austria
Landeskrankenhaus Feldkirch
Feldkirch, Austria, A-6806
Universitaetsklinik Innsbruck/ Klinik für Innere Medizin
Innsbruck, Austria, A-6020
A.ö. Landeskrankenhaus Leoben
Leoben, Austria, A-8700
Krankenhaus d. Barmherzigen Schwestern Linz
Linz, Austria, A-4010
Krankenhaus der Elisabethinen Linz
Linz, Austria, A-4010
Krankenhaus der Stadt Linz
Linz, Austria, A-4020
Universitaetsklinik f. Innere Medizin III
Salzburg, Austria, A-5020
AKH Wien / Haematologie u. Haemostaseologie
Vienna, Austria, A-1090
Hanusch Krankenhaus
Vienna, Austria, A-1140
Klinikum Kreuzschwestern Wels GmbH
Wels, Austria, A-4600
Sponsors and Collaborators
Arbeitsgemeinschaft medikamentoese Tumortherapie
Investigators
Principal Investigator: Michael A Fridrik, MD AKh Linz
  More Information

No publications provided

Responsible Party: Arbeitsgemeinschaft medikamentoese Tumortherapie
ClinicalTrials.gov Identifier: NCT00575406     History of Changes
Other Study ID Numbers: NHL-14, EudraCT 2007-004970-24
Study First Received: December 17, 2007
Last Updated: August 29, 2013
Health Authority: Austria: Federal Office for Safety in Health Care

Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Cyclophosphamide
Doxorubicin
Liposomal doxorubicin
Methylprednisolone
Methylprednisolone Hemisuccinate
Methylprednisolone acetate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Rituximab
Alkylating Agents
Anti-Inflammatory Agents
Antibiotics, Antineoplastic
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antineoplastic Agents, Hormonal
Antirheumatic Agents
Autonomic Agents

ClinicalTrials.gov processed this record on November 20, 2014