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

Sponsor
Arbeitsgemeinschaft medikamentoese Tumortherapie
Study ID
NCT00575406
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — DRUG
    i.v., 375 mg/m2, d0 or d1 of each treatment cycle
  • Cyclophosphamide — DRUG
    i.v., 750 mg/m2, d1 of each treatment cycle
  • Doxorubicin — DRUG
    i.v., 50 mg/m2, d1 of each treatment cycle
  • liposomal Doxorubicin — DRUG
    i.v., 50 mg/m2, d1 of each treatment cycle
  • Vincristin — DRUG
    i.v., 2mg, d1 of each treatment cycle
  • Prednisolone — DRUG
    p.o., 100mg, d1 - d5 of each treatment cycle

Study Details

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).

Key Dates

Start date
Dec 31, 2007
Status verified
Aug 2013
Primary completion
Jan 31, 2012
Completion
Jan 31, 2012

Study Design

Enrollment
94 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: R-CHOP
    Treatment with Rituximab, Cyclophosphamide, Doxorubicin, Vincristin and Prednisolone
  • Experimental: R-COMP
    Treatment with Rituximab, Cyclophosphamide, liposomal Doxorubicin, Vincristin and Prednisolone

Primary Outcome Measure

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

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