ACVBP Followed by ASCT in Patients With BCL-2 Positive Diffuse Large B-Cell Lymphoma
Overview[ - collapse ][ - ]
| Purpose | The primary objective of the study is to evaluate the efficacy of ASCT as consolidation in case of bcl-2 overexpression in non previously treated patients aged 60 years or less with low-intermediate risk diffuse large B-cell lymphoma who responded to ACVBP regimen. Our goal is to obtain a 15% increase of event-free survival at 2 years. |
|---|---|
| Condition | Lymphoma, Large-Cell, Diffuse |
| Intervention | Drug: doxorubicin Drug: cyclophosphamide Procedure: Autologous stem cell transplantation |
| Phase | Phase 2/Phase 3 |
| Sponsor | Lymphoma Study Association |
| Responsible Party | Lymphoma Study Association |
| ClinicalTrials.gov Identifier | NCT00169130 |
| First Received | September 12, 2005 |
| Last Updated | July 12, 2007 |
| Last verified | July 2007 |
Tracking Information[ + expand ][ + ]
| First Received Date | September 12, 2005 |
|---|---|
| Last Updated Date | July 12, 2007 |
| Start Date | October 1999 |
| Estimated Primary Completion Date | Not Provided |
| Current Primary Outcome Measures | Event free survival. |
| Current Secondary Outcome Measures |
|
Descriptive Information[ + expand ][ + ]
| Brief Title | ACVBP Followed by ASCT in Patients With BCL-2 Positive Diffuse Large B-Cell Lymphoma |
|---|---|
| Official Title | Prospective Study of ACVBP Followed by Autologous Stem Cell Transplantation in Case of BCL-2 Overexpression in Non Previously Treated Patients Aged 60 Years or Less With Low-Intermediate Risk Diffuse Large B-Cell Lymphoma |
| Brief Summary | The primary objective of the study is to evaluate the efficacy of ASCT as consolidation in case of bcl-2 overexpression in non previously treated patients aged 60 years or less with low-intermediate risk diffuse large B-cell lymphoma who responded to ACVBP regimen. Our goal is to obtain a 15% increase of event-free survival at 2 years. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 2/Phase 3 |
| Study Design | Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Condition | Lymphoma, Large-Cell, Diffuse |
| Intervention | Drug: doxorubicin Drug: cyclophosphamide Procedure: Autologous stem cell transplantation |
| Study Arm (s) | Not Provided |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 300 |
| Estimated Completion Date | Not Provided |
| Estimated Primary Completion Date | Not Provided |
| Eligibility Criteria | Inclusion Criteria: - Patient with diffuse large B-cell lymphoma according to the WHO classification (anti CD20 labeling) - Aged 18 to 60 years - Non previously treated - With one and only one of the following adverse characteristics: ECOG performance status 2 or more, or Ann Arbor stage III or IV, or elevated LDH level - Negative HIV, HBV and HCV serologies (except vaccination) - With a minimum life expectancy of 3 months - Having previously signed a written informed consent Exclusion Criteria: - Any history of treated or non-treated indolent lymphoma. - T-cell lymphoma. - Central nervous system or meningeal involvement by lymphoma. - Any Contra-indication to any drug contained in the chemotherapy regimens. - 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. - Serious active disease (according to the investigator’s decision). - Poor bone marrow reserve as defined by neutrophils <1.5G/l or platelets<100G/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. - Childbearing woman. - Patients previously treated with an organ transplantation. |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | Belgium, France |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00169130 |
|---|---|
| Other Study ID Numbers | LNH98-B2 |
| Has Data Monitoring Committee | Not Provided |
| Information Provided By | Lymphoma Study Association |
| Study Sponsor | Lymphoma Study Association |
| Collaborators | Association pour la Recherche sur le Cancer (ARC), Villejuif, France. |
| Investigators | Principal Investigator: Pierre Morel, MD Centre Hospitalier Schaffner, Lens FRANCE |
| Verification Date | July 2007 |
Locations[ + expand ][ + ]
| Service d'Hematologie | Mont-Godinne, Belgium |
|---|---|
| Hôpital Henri Mondor | Creteil, France |
| Hôpital Saint Louis | Paris, France, 75010 |
| Centre Hospitalier Lyon Sud | Pierre-Bénite, France |
| Centre Henri Becquerel | Rouen, France, 76000 |