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NCT Number: NCT00575406

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

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).

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Key information

Conditions

Diffuse Large B-cell Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Landeskrankenhaus Feldkirch, Feldkirch, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rituximab

Drug

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

Other names: MabThera

Cyclophosphamide

Drug

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

Other names: Cytoxan

Doxorubicin

Drug

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

Other names: Adriamycin

Liposomal Doxorubicin

Drug

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

Other names: Myocet

Vincristin

Drug

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

Other names: Oncovin

Prednisolone

Drug

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

Primary outcomes

  1. Reduction of cardiotoxicity in the R-COMP arm versus R-CHOP

    Time frame: Study duration

Secondary outcomes

  1. Significance of serial NT-proBNP measurements for determination of anthracycline-dependent cardiotoxicity

    Time frame: Study Duration

  2. Feasibility of evaluation with Haematopoietic Cell Transplantation Comorbidity Index (HCT-CI)

    Time frame: Study duration

  3. Rate of Complete Responses

    Time frame: At end of treatment

  4. Difference in Overall Survival at 3 and 5 yrs

    Time frame: 5 years

  5. Difference in Event-free Survival at 3 and 5 yrs

    Time frame: 5 years

  6. Difference in Progression-free Survival at 3 and 5 yrs

    Time frame: 5 years

  7. Difference in cause-specific death

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

Arbeitsgemeinschaft medikamentoese Tumortherapie

Other

Registry information

Official study 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)

Acronym: NHL-14

Important dates

Study start
2007
Primary completion
2012
Study completion
2012
First posted
Dec 18, 2007
Registry last updated
Aug 30, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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