ACVBP Plus Rituximab Versus CHOP Plus Rituximab in Patients With Diffuse Large B-cell Lymphoma and Age-adjusted IPI of 1
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|ClinicalTrials.gov Identifier: NCT00140595|
Recruitment Status : Completed
First Posted : September 1, 2005
Last Update Posted : March 4, 2011
|Condition or disease||Intervention/treatment||Phase|
|Diffuse Large-Cell Lymphoma||Drug: rituximab Drug: doxorubicin Drug: cyclophosphamide||Phase 3|
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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||380 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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.|
|Study Start Date :||December 2003|
|Actual Primary Completion Date :||January 2009|
|Actual Study Completion Date :||January 2009|
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|