ACVBP Plus Rituximab Versus CHOP Plus Rituximab in Patients With Diffuse Large B-cell Lymphoma and Age-adjusted IPI of 1
|Diffuse Large-Cell Lymphoma||Drug: rituximab Drug: doxorubicin Drug: cyclophosphamide||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||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.|
- 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.
- Response rate at the end of the treatment, progression rate, relapse rate, disease-free survival for complete responders, overall survival, neuromeningeal relapse rate and additional toxicities with ACVBP+rituximab combination
|Study Start Date:||December 2003|
|Study Completion Date:||January 2009|
|Primary Completion Date:||January 2009 (Final data collection date for primary outcome measure)|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00140595
|Groupe d'étude des lymphomes de l'adulte|
|Hôpital Henri Mondor|
|Créteil, France, 94010|
|Centre Léon Bérard|
|Lyon, France, 69008|
|Hôpital Saint Louis|
|Paris, France, 75010|
|Hématologie Adultes - Hôpital Necker|
|Paris, France, 75743|
|Service d'Hématologie - Centre Hospitalier Lyon-Sud|
|Pierre-Bénite cedex, France, 69495|
|Centre Hospitalier Robert Debré|
|Reims, France, 51092|
|Centre Henri Becquerel|
|Rouen, France, 76038|
|Hématologie CHU Purpan|
|Toulouse, France, 31059|
|Institut Gustave Roussy|
|Principal Investigator:||Christian Recher, MD||Lymphoma Study Association|
|Study Chair:||Hervé Tilly, MD||Lymphoma Study Association|
|Study Chair:||Corinne Haioun, MD||Lymphoma Study Association|