ACVBP Plus Rituximab in Patients Aged From 18 to 59 Years With High-risk Diffuse Large B-cell Lymphoma
Recruitment status was Active, not recruiting
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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 | Intervention | Phase |
|---|---|---|
|
Diffuse Large Cell Lymphoma |
Drug: rituximab Drug: doxorubicin Drug: cyclophosphamide Procedure: autologous stem cell transplantation |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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) |
- Complete remission rate (CR + CRu) [ Time Frame: 4 cycles of ACVBP ] [ Designated as safety issue: No ]
- 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 ]
| Estimated Enrollment: | 150 |
| Study Start Date: | December 2003 |
| Estimated Study Completion Date: | September 2008 |
| Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 59 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| Belgium | |
| Groupe d'Etude des Lymphomes de l'adulte | |
| Mont-Godinne, Belgium | |
| France | |
| 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 | |
| Switzerland | |
| Schweirische Arbeitsgruppe fur klinische Krebsforschung | |
| Lausanne, Switzerland | |
| Principal Investigator: | Olivier Fitoussi, MD | Lymphoma Study Association |
| Study Director: | Christian Gisselbrecht, MD | Lymphoma Study Association |
| Study Chair: | Corinne Haioun, MD | Lymphoma Study Association |
| Study Chair: | Hervé Tilly, MD | Lymphoma Study Association |
More Information
Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Hervé Tilly, GELA |
| ClinicalTrials.gov Identifier: | NCT00144807 History of Changes |
| Other Study ID Numbers: | LNH03-3B |
| Study First Received: | September 2, 2005 |
| Last Updated: | August 26, 2009 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by Lymphoma Study Association:
|
lymphoma, diffuse large B-cell rituximab chemotherapy autologous stem cell transplant |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, Large B-Cell, Diffuse Lymphoma, Non-Hodgkin Lymphoma, B-Cell Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Cyclophosphamide Rituximab Doxorubicin |
Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Antibiotics, Antineoplastic |
ClinicalTrials.gov processed this record on October 16, 2012
