Trial Information
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)
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Reduction of cardiotoxicity in the R-COMP arm versus R-CHOP
Outcome Time Frame:
Study duration
Safety Issue:
Yes
Principal Investigator
Michael A Fridrik, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
AKh Linz
Authority:
Austria: Federal Office for Safety in Health Care
Study ID:
NHL-14
NCT ID:
NCT00575406
Start Date:
December 2007
Completion Date:
March 2013
Related Keywords:
- Diffuse Large B-Cell Lymphoma
- Lymphoma
- Lymphoma, B-Cell
- Lymphoma, Large B-Cell, Diffuse