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
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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.
Christian Recher, MD
Lymphoma Study Association
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)