Overview

ACVBP Plus Rituximab Versus CHOP Plus Rituximab in Patients With Diffuse Large B-cell Lymphoma and Age-adjusted IPI of 1

Status:
Completed

Trial end date:
2009-01-01

Target enrollment:
0

Participant gender:
All

Summary

This study is a multicentric randomized trial evaluating the efficacy of the combination ACVBP+rituximab compared to the combination of CHOP+rituximab in patients aged from 18 to 59 years with diffuse large B-cell lymphoma and one factor of the age-adjusted international prognostic index (IPI).

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Lymphoma Study Association

Collaborator:

Amgen

Treatments:

Cyclophosphamide
Doxorubicin
Rituximab

Criteria

Inclusion Criteria:

Patient with histologically proven CD20+ diffuse large B-cell lymphoma (WHO classification)
Aged from 18 to 59 years. Age-adjusted International Prognostic Index equal to 1 (elevated
LDH level OR stage III-IV OR ECOG status 2-3-4).

Patient not previously treated. With a minimum life expectancy of 3 months. Negative HIV,
HBV and HCV serologies test 4 weeks (except after vaccination). Having previously signed a
written informed consent.

Exclusion Criteria:

Any other histological type of lymphoma. Any history of treated or non-treated indolent
lymphoma. However, patients not previously diagnosed and having a diffuse large B-cell
lymphoma with some small cell infiltration in bone marrow or lymph node may be included.

Central nervous system or meningeal involvement by lymphoma. Contra-indication to any drug
contained in the chemotherapy regimens. Any serious active disease (according to the
investigator's decision). Poor renal function (creatinin level>150µmol/l), poor hepatic
function (total bilirubin level>30mmol/l, transaminases>2.5 maximum normal level) unless
these abnormalities are related to the lymphoma.

Poor bone marrow reserve as defined by neutrophils <1.5 G/l or platelets <100 G/l, unless
related to bone marrow infiltration.

Any history of cancer during the last 5 years with the exception of non-melanoma skin
tumors or stage 0 (in situ) cervical carcinoma.

Treatment with any investigational drug within 30 days before planned first cycle of
chemotherapy and during the study.

Pregnant or lactating women. Adult patient under tutelage.