Efficacy Study of Rituximab After ASCT in High-Risk Diffuse Large B-Cell Lymphoma
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|ClinicalTrials.gov Identifier: NCT00169169|
Recruitment Status : Terminated
First Posted : September 15, 2005
Last Update Posted : September 15, 2005
|Condition or disease||Intervention/treatment||Phase|
|CD20-Positive Large B-Cell Lymphoma||Drug: ACVBP Drug: ACE Drug: rituximab Procedure: Autologous stem cell transplant||Phase 3|
This is a multicentric, open-label, randomized clinical study, evaluating the efficacy and the safety of Rituximab After ASCT in patients aged 18 to 59 years with previously untreated High-Risk (aa-IPI 2 or 3 ) Diffuse Large B-Cell Lymphoma .
The duration of the treatment period is approximately 25 weeks and patients are followed until Death.
From 10/99 to 05/03, 476 patients were enrolled. 235 patients were assigned to receive ACE and 241 to ACVBP. Among the 331 patients, in Complete response (CR+CRu) after induction, who received HDC, 269 were randomized (R2) after hematological recovery to receive either rituximab (n=139) or nothing (n=130).
The final analysis was performed in June 2005.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||430 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomised Phase 3 Study of Rituximab in High-Risk Patients With Diffuse Large B-Cell Lymphoma Who Received a First-Line Consolidative Chemotherapy With Autologous Stem Cell Transplant (ASCT).|
|Study Start Date :||October 1999|
|Study Completion Date :||August 2005|
- - To compare event-free survival of patients randomized to receive Rituximab or no further therapy after HDT
- - To compare response rate to induction treatments (ACVBP vs AC/ACE).
- - To evaluate response rate at the end of treatment.
- - To compare overall survival (ACVBP vs AC/ACE; Rituximab / nothing)
- - To evaluate the safety and tolerability of Rituximab
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 ClinicalTrials.gov identifier (NCT number): NCT00169169
|Hôpital Henri Mondor|
|Hôpital Saint Louis|
|Service d'Hématologie - Centre Hospitalier Lyon-Sud|
|Pierre-Bénite cedex, France|
|Centre Henri Becquerel|
|CHRU de Nancy Brabois|
|Study Chair:||Corinne Haioun||Hôpital Henri Mondor, Créteil, France|