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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)


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Diffuse Large B-cell Lymphoma

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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

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