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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)

Primary Purpose

Diffuse Large B-Cell Lymphoma

Status
Completed
Phase
Phase 2
Locations
Austria
Study Type
Interventional
Intervention
Rituximab
Cyclophosphamide
Doxorubicin
liposomal Doxorubicin
Vincristin
Prednisolone
Sponsored by
Arbeitsgemeinschaft medikamentoese Tumortherapie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diffuse Large B-Cell Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Landeskrankenhaus Feldkirch
  • Universitaetsklinik Innsbruck/ Klinik für Innere Medizin
  • A.ö. Landeskrankenhaus Leoben
  • Krankenhaus d. Barmherzigen Schwestern Linz
  • Krankenhaus der Elisabethinen Linz
  • Krankenhaus der Stadt Linz
  • Universitaetsklinik f. Innere Medizin III
  • AKH Wien / Haematologie u. Haemostaseologie
  • Hanusch Krankenhaus
  • Klinikum Kreuzschwestern Wels GmbH

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

R-CHOP

R-COMP

Arm Description

Treatment with Rituximab, Cyclophosphamide, Doxorubicin, Vincristin and Prednisolone

Treatment with Rituximab, Cyclophosphamide, liposomal Doxorubicin, Vincristin and Prednisolone

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Significance of serial NT-proBNP measurements for determination of anthracycline-dependent cardiotoxicity
Feasibility of evaluation with Haematopoietic Cell Transplantation Comorbidity Index (HCT-CI)
Rate of Complete Responses
Difference in Overall Survival at 3 and 5 yrs
Difference in Event-free Survival at 3 and 5 yrs
Difference in Progression-free Survival at 3 and 5 yrs
Difference in cause-specific death

Full Information

First Posted
December 17, 2007
Last Updated
August 29, 2013
Sponsor
Arbeitsgemeinschaft medikamentoese Tumortherapie
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1. Study Identification

Unique Protocol Identification Number
NCT00575406
Brief Title
Multicentre Study to Determine the Cardiotoxicity of R-CHOP Compared to R-COMP in Patients With Diffuse Large B-Cell Lymphoma
Acronym
NHL-14
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)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Arbeitsgemeinschaft medikamentoese Tumortherapie

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diffuse Large B-Cell Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
94 (Actual)

8. Arms, Groups, and Interventions

Arm Title
R-CHOP
Arm Type
Active Comparator
Arm Description
Treatment with Rituximab, Cyclophosphamide, Doxorubicin, Vincristin and Prednisolone
Arm Title
R-COMP
Arm Type
Experimental
Arm Description
Treatment with Rituximab, Cyclophosphamide, liposomal Doxorubicin, Vincristin and Prednisolone
Intervention Type
Drug
Intervention Name(s)
Rituximab
Other Intervention Name(s)
MabThera
Intervention Description
i.v., 375 mg/m2, d0 or d1 of each treatment cycle
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Other Intervention Name(s)
Cytoxan
Intervention Description
i.v., 750 mg/m2, d1 of each treatment cycle
Intervention Type
Drug
Intervention Name(s)
Doxorubicin
Other Intervention Name(s)
Adriamycin
Intervention Description
i.v., 50 mg/m2, d1 of each treatment cycle
Intervention Type
Drug
Intervention Name(s)
liposomal Doxorubicin
Other Intervention Name(s)
Myocet
Intervention Description
i.v., 50 mg/m2, d1 of each treatment cycle
Intervention Type
Drug
Intervention Name(s)
Vincristin
Other Intervention Name(s)
Oncovin
Intervention Description
i.v., 2mg, d1 of each treatment cycle
Intervention Type
Drug
Intervention Name(s)
Prednisolone
Intervention Description
p.o., 100mg, d1 - d5 of each treatment cycle
Primary Outcome Measure Information:
Title
Reduction of cardiotoxicity in the R-COMP arm versus R-CHOP
Time Frame
Study duration
Secondary Outcome Measure Information:
Title
Significance of serial NT-proBNP measurements for determination of anthracycline-dependent cardiotoxicity
Time Frame
Study Duration
Title
Feasibility of evaluation with Haematopoietic Cell Transplantation Comorbidity Index (HCT-CI)
Time Frame
Study duration
Title
Rate of Complete Responses
Time Frame
At end of treatment
Title
Difference in Overall Survival at 3 and 5 yrs
Time Frame
5 years
Title
Difference in Event-free Survival at 3 and 5 yrs
Time Frame
5 years
Title
Difference in Progression-free Survival at 3 and 5 yrs
Time Frame
5 years
Title
Difference in cause-specific death
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael A Fridrik, MD
Organizational Affiliation
AKh Linz
Official's Role
Principal Investigator
Facility Information:
Facility Name
Landeskrankenhaus Feldkirch
City
Feldkirch
ZIP/Postal Code
A-6806
Country
Austria
Facility Name
Universitaetsklinik Innsbruck/ Klinik für Innere Medizin
City
Innsbruck
ZIP/Postal Code
A-6020
Country
Austria
Facility Name
A.ö. Landeskrankenhaus Leoben
City
Leoben
ZIP/Postal Code
A-8700
Country
Austria
Facility Name
Krankenhaus d. Barmherzigen Schwestern Linz
City
Linz
ZIP/Postal Code
A-4010
Country
Austria
Facility Name
Krankenhaus der Elisabethinen Linz
City
Linz
ZIP/Postal Code
A-4010
Country
Austria
Facility Name
Krankenhaus der Stadt Linz
City
Linz
ZIP/Postal Code
A-4020
Country
Austria
Facility Name
Universitaetsklinik f. Innere Medizin III
City
Salzburg
ZIP/Postal Code
A-5020
Country
Austria
Facility Name
AKH Wien / Haematologie u. Haemostaseologie
City
Vienna
ZIP/Postal Code
A-1090
Country
Austria
Facility Name
Hanusch Krankenhaus
City
Vienna
ZIP/Postal Code
A-1140
Country
Austria
Facility Name
Klinikum Kreuzschwestern Wels GmbH
City
Wels
ZIP/Postal Code
A-4600
Country
Austria

12. IPD Sharing Statement

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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

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