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

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)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00575406

Acronym

NHL-14

Enrollment

Registered

2007-12-18

Start date

2007-12-31

Completion date

2012-01-31

Last updated

2013-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diffuse Large B-Cell Lymphoma

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).

Interventions

DRUGRituximab

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

DRUGCyclophosphamide

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

DRUGDoxorubicin

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

DRUGliposomal Doxorubicin

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

DRUGVincristin

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

DRUGPrednisolone

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Reduction of cardiotoxicity in the R-COMP arm versus R-CHOP	Study duration

Secondary

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

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026