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

December 17, 2007
August 29, 2013
December 2007
January 2012   (final data collection date for primary outcome measure)
Reduction of cardiotoxicity in the R-COMP arm versus R-CHOP [ Time Frame: Study duration ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00575406 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Multicentre Study to Determine the Cardiotoxicity of R-CHOP Compared to R-COMP in Patients With Diffuse Large B-Cell Lymphoma
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).

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Diffuse Large B-Cell Lymphoma
  • 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: 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
  • Active Comparator: R-CHOP
    Treatment with Rituximab, Cyclophosphamide, Doxorubicin, Vincristin and Prednisolone
    Interventions:
    • Drug: Rituximab
    • Drug: Cyclophosphamide
    • Drug: Doxorubicin
    • Drug: Vincristin
    • Drug: Prednisolone
  • Experimental: R-COMP
    Treatment with Rituximab, Cyclophosphamide, liposomal Doxorubicin, Vincristin and Prednisolone
    Interventions:
    • Drug: Rituximab
    • Drug: Cyclophosphamide
    • Drug: liposomal Doxorubicin
    • Drug: Vincristin
    • Drug: Prednisolone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
94
January 2012
January 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Austria
 
NCT00575406
NHL-14, EudraCT 2007-004970-24
No
Arbeitsgemeinschaft medikamentoese Tumortherapie
Arbeitsgemeinschaft medikamentoese Tumortherapie
Not Provided
Principal Investigator: Michael A Fridrik, MD AKh Linz
Arbeitsgemeinschaft medikamentoese Tumortherapie
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP