ACVBP Plus Rituximab in Patients Aged From 18 to 59 Years With High-risk Diffuse Large B-cell Lymphoma
Overview[ - collapse ][ - ]
| Purpose | This study is a multicentric trial evaluating the efficacy of R-ACVBP in patients aged 18 to 59 years with high risk diffuse large B-cell lymphoma |
|---|---|
| Condition | Diffuse Large Cell Lymphoma |
| Intervention | Drug: rituximab Drug: doxorubicin Drug: cyclophosphamide Procedure: autologous stem cell transplantation |
| Phase | Phase 2 |
| Sponsor | Lymphoma Study Association |
| Responsible Party | Lymphoma Study Association |
| ClinicalTrials.gov Identifier | NCT00144807 |
| First Received | September 2, 2005 |
| Last Updated | August 26, 2009 |
| Last verified | August 2009 |
Tracking Information[ + expand ][ + ]
| First Received Date | September 2, 2005 |
|---|---|
| Last Updated Date | August 26, 2009 |
| Start Date | December 2003 |
| Estimated Primary Completion Date | September 2008 |
| Current Primary Outcome Measures | Complete remission rate (CR + CRu) [Time Frame: 4 cycles of ACVBP] [Designated as safety issue: No] |
| Current Secondary Outcome Measures | Event-free survival and overall survival of patients submitted to autologous transplant and of the entire study population [Time Frame: 3 years] [Designated as safety issue: Yes] |
Descriptive Information[ + expand ][ + ]
| Brief Title | ACVBP Plus Rituximab in Patients Aged From 18 to 59 Years With High-risk Diffuse Large B-cell Lymphoma |
|---|---|
| Official Title | Study of ACVBP Plus Rituximab in Previously Untreated Patients Aged From 18 to 59 Years With High Risk Diffuse Large B-cell Lymphoma (Age-adjusted IPI = 2-3) |
| Brief Summary | This study is a multicentric trial evaluating the efficacy of R-ACVBP in patients aged 18 to 59 years with high risk diffuse large B-cell lymphoma |
| Detailed Description | This phase II non randomized study is based on the results of the LNH 98-5, LNH 87-2, LNH 93-3 and LNH 98-3B studies. To date, the ACVBP regimen is considered as the reference induction treatment of the GELA in patients with 2-3 adverse prognostic factors. Indeed neither NCVBP regimen (LNH87-2) nor ECVBP (LNH93-3) led to increase the complete remission rate. More recently, the addition of etoposide to doxorubicin and cyclophosphamide (LNH98-3B) did not enhanced the complete remission rate with more toxicity. In patients < 60 years with 2-3 adverse prognostic factors the complete remission rate remained less than 65% in all these studies. Consequently, increasing the quality of response remains a major goal in this group of young patients with adverse prognostic factors. It has been shown that the addition of rituximab to CHOP regimen significantly improved the CR rate in elderly patients with previously untreated large B-cell lymphoma when compared with CHOP alone without additional toxicities. Moreover, event-free survival and overall survival were found to be longer in the R-CHOP group. The present trial will evaluate the response rate obtained after four cycles of ACVBP combined to rituximab (R-ACVBP) before high dose therapy consolidative treatment in this group of higher risk patients. The LNH87-2 study has shown that intensive consolidation treatment with autologous stem cell support was beneficial to high risk patients in good response after a full induction phase. The long-term results of this randomised study prompted us to consider high dose therapy as the best consolidative option for these patients. |
| Study Type | Interventional |
| Study Phase | Phase 2 |
| Study Design | Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Condition | Diffuse Large Cell Lymphoma |
| Intervention | Drug: rituximab Drug: doxorubicin Drug: cyclophosphamide Procedure: autologous stem cell transplantation |
| Study Arm (s) | Not Provided |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Active, not recruiting |
|---|---|
| Estimated Enrollment | 150 |
| Estimated Completion Date | September 2008 |
| Estimated Primary Completion Date | September 2008 |
| Eligibility Criteria | Inclusion Criteria: Patient with histologically proven CD20+ diffuse large B-cell lymphoma (WHO classification). Age from 18 to 59 years, eligible for transplant. Patient not previously treated. Age adjusted IPI = 2 or 3 With a minimum life expectancy of 3 months Negative HIV, HBV and HCV serologies < 4 weeks (except after vaccination). Having signed a written informed consent. Exclusion Criteria: 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. Poor renal function (creatinin level >150 mmol/l), poor hepatic function (total bilirubin level >30 mmol/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. Any serious active disease (according to the investigator's decision). 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, Switzerland |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00144807 |
|---|---|
| Other Study ID Numbers | LNH03-3B |
| Has Data Monitoring Committee | Not Provided |
| Information Provided By | Lymphoma Study Association |
| Study Sponsor | Lymphoma Study Association |
| Collaborators | Not Provided |
| Investigators | Principal Investigator: Olivier Fitoussi, MD Lymphoma Study AssociationStudy Director: Christian Gisselbrecht, MD Lymphoma Study AssociationStudy Chair: Corinne Haioun, MD Lymphoma Study AssociationStudy Chair: Hervé Tilly, MD Lymphoma Study Association |
| Verification Date | August 2009 |
Locations[ + expand ][ + ]
| Groupe d'Etude des Lymphomes de l'adulte | Mont-Godinne, Belgium |
|---|---|
| Polyclinique Bordeaux Nord | Bordeaux, France, 33300 |
| Hôpital Henri Mondor | Créteil, France, 94010 |
| Hématologie CHU de Lille | Lille, France, 59000 |
| Centre Léon Bérard | Lyon, France, 69008 |
| Hématologie Adultes - Hôpital Necker | Paris, France, 75743 |
| Hôpital Saint Louis | Paris, France, 75010 |
| 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 |
| Schweirische Arbeitsgruppe fur klinische Krebsforschung | Lausanne, Switzerland |