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Randomized Study of ACVBP Plus Rituximab Versus CHOP Plus Rituximab in Patients Aged From 18 to 59 Years With Diffuse Large B-cell Lymphoma and a Age-adjusted IPI of 1.

Phase 3
18 Years
59 Years
Not Enrolling
Diffuse Large-Cell Lymphoma

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Trial Information

Randomized Study of ACVBP Plus Rituximab Versus CHOP Plus Rituximab in Patients Aged From 18 to 59 Years With Diffuse Large B-cell Lymphoma and a Age-adjusted IPI of 1.

This phase III multicentric open label randomized study is based on the results of previous
LNH 93-5 and LNH98-5 studies.

The LNH93-5 study has shown that the ACVBP regimen gave a longer EFS (39% vs 29% at 5 years,
p=0.005) and a longer overall survival (46% vs 38% at 5 years, p=0.036) than CHOP in
patients aged between 61 and 69 with an IPI score ≥1. However ACVBP had a more important
toxicity and a higher treatment related mortality (13% vs 7%, p<0.01), specially after 65
years. In younger patients ACVBP is better tolerated.

The addition of Rituximab to standard CHOP (R-CHOP) has been shown in LNH98-5 study to
improve complete remission rate (CR), event-free survival (EFS) and overall survival (OS) in
elderly patients with B-DLCL. Considering only patients with an aa-IPI score of 1, the 2
year EFS was 75% in the R-CHOP group as compared with 42% in the CHOP group.

This study is designed to test whether addition of rituximab to ACVBP is better than R-CHOP
in patients younger than 60. Primary endpoint is event-free survival, we expect a gain in 2
years-EFS of 10% in R-ACVBP group as compared with R-CHOP group.

This study is a multicentric, phase III open-label, randomized trial evaluating the efficacy
of ACVBP+rituximab compared to CHOP+rituximab in patients aged from 18 to 59 years with non
previously treated diffuse large B-cell lymphoma and one factor of the age-adjusted
international prognostic index

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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Event-free survival (EFS), events defined as death from any cause, relapse for complete responders (CR) and unconfirmed complete responders (CRu), progression during or after treatment, changes of therapy during allocated treatment.

Principal Investigator

Christian Recher, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Lymphoma Study Association


France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:




Start Date:

December 2003

Completion Date:

January 2009

Related Keywords:

  • Diffuse Large-Cell Lymphoma
  • Lymphoma, diffuse large B-cell
  • rituximab
  • chemotherapy
  • Lymphoma
  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, Non-Hodgkin
  • Lymphoma, B-Cell