ACVBP Plus Rituximab Versus CHOP Plus Rituximab in Patients With Diffuse Large B-cell Lymphoma and Age-adjusted IPI of 1
Overview[ - collapse ][ - ]
| Purpose | 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 | Diffuse Large-Cell Lymphoma |
| Intervention | Drug: rituximab Drug: doxorubicin Drug: cyclophosphamide |
| Phase | Phase 3 |
| Sponsor | Lymphoma Study Association |
| Responsible Party | Lymphoma Study Association |
| ClinicalTrials.gov Identifier | NCT00140595 |
| First Received | August 31, 2005 |
| Last Updated | March 3, 2011 |
| Last verified | March 2011 |
Tracking Information[ + expand ][ + ]
| First Received Date | August 31, 2005 |
|---|---|
| Last Updated Date | March 3, 2011 |
| Start Date | December 2003 |
| Estimated Primary Completion Date | January 2009 |
| Current Primary Outcome Measures | 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. |
| Current Secondary Outcome Measures | 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 |
Descriptive Information[ + expand ][ + ]
| Brief Title | ACVBP Plus Rituximab Versus CHOP Plus Rituximab in Patients With Diffuse Large B-cell Lymphoma and Age-adjusted IPI of 1 |
|---|---|
| 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. |
| 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). |
| 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 |
| Study Type | Interventional |
| Study Phase | Phase 3 |
| Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Condition | Diffuse Large-Cell Lymphoma |
| Intervention | Drug: rituximab Drug: doxorubicin Drug: cyclophosphamide |
| Study Arm (s) | Not Provided |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 380 |
| Estimated Completion Date | January 2009 |
| Estimated Primary Completion Date | January 2009 |
| Eligibility Criteria | 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. |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | Belgium, France |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00140595 |
|---|---|
| Other Study ID Numbers | LNH03-2B |
| Has Data Monitoring Committee | Not Provided |
| Information Provided By | Lymphoma Study Association |
| Study Sponsor | Lymphoma Study Association |
| Collaborators | Amgen |
| Investigators | Principal Investigator: Christian Recher, MD Lymphoma Study AssociationStudy Chair: Hervé Tilly, MD Lymphoma Study AssociationStudy Chair: Corinne Haioun, MD Lymphoma Study Association |
| Verification Date | March 2011 |
Locations[ + expand ][ + ]
| 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 |