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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00140595
Recruitment Status : Completed
First Posted : September 1, 2005
Last Update Posted : March 4, 2011
Information provided by:
Lymphoma Study Association

Brief 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).

Condition or disease Intervention/treatment Phase
Diffuse Large-Cell Lymphoma Drug: rituximab Drug: doxorubicin Drug: cyclophosphamide Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 380 participants
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.
Study Start Date : December 2003
Actual Primary Completion Date : January 2009
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Rituximab

Primary Outcome Measures :
  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.

Secondary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00140595

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Groupe d'étude des lymphomes de l'adulte
Yvoir, Belgium
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
Villejuif, France
Sponsors and Collaborators
Lymphoma Study Association
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Principal Investigator: Christian Recher, MD Lymphoma Study Association
Study Chair: Hervé Tilly, MD Lymphoma Study Association
Study Chair: Corinne Haioun, MD Lymphoma Study Association
Publications automatically indexed to this study by Identifier (NCT Number):

Layout table for additonal information Identifier: NCT00140595    
Other Study ID Numbers: LNH03-2B
First Posted: September 1, 2005    Key Record Dates
Last Update Posted: March 4, 2011
Last Verified: March 2011
Keywords provided by Lymphoma Study Association:
Lymphoma, diffuse large B-cell
Additional relevant MeSH terms:
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Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, B-Cell
Lymphoma, Non-Hodgkin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antineoplastic Agents, Immunological
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors