NCT00140595

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

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.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 380 (estimated)
• Sponsor: Lymphoma Study Association · Academic / Other
• Sex: All
• Age: 18 Years – 59 Years
• Healthy volunteers: Not accepted

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).

Detailed description

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

Conditions

• Diffuse Large-Cell Lymphoma

Interventions

Type	Name	Description
DRUG	rituximab
DRUG	doxorubicin
DRUG	cyclophosphamide

Timeline

• Start date: 2003-12-01
• Primary completion: 2009-01-01
• Completion: 2009-01-01
• First posted: 2005-09-01
• Last updated: 2011-03-04

Locations

10 sites across 2 countries: Belgium, France