Primary Rituximab and Maintenance
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00140582|
Recruitment Status : Completed
First Posted : September 1, 2005
Last Update Posted : March 13, 2017
- Primary objective: To evaluate in patients with advanced follicular lymphoma the benefit of maintenance therapy with rituximab after induction of response with chemotherapy plus rituximab in comparison with no maintenance therapy
- Secondary objective: To evaluate response rates, event driven survival endpoints (EFS, PFS, OS) and quality of life of four different chemotherapy regimens combined with rituximab, with or without maintenance with rituximab, for first line treatment of advanced stage follicular lymphoma.
- Study Design This is an international open-label, multicentre, randomized study with two treatment phases. In the induction phase patients have to respond to 1st line induction treatment in order to be eligible for randomization to the second phase of maintenance treatment or observation. After the maintenance period patients will be included in the follow up phase for 3 years.
|Condition or disease||Intervention/treatment||Phase|
|Follicular Lymphoma||Drug: Rituximab||Phase 3|
- First period: Induction of response with 8 x rituximab combined with 8 cycles of CVP or 6 cycles of CHOP in 21-day cycles or 6 cycles of FCM in 28-day cycles or 6 cycles of MCP in 28-day cycles.
- Second period: rituximab 375 mg/m2 every 8 weeks for 24 months (12 injections) or control with no treatment
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1217 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Advanced Follicular Lymphoma Evaluating the Benefit of Maintenance Therapy With Rituximab (MabThera®) After Induction of Response With Chemotherapy Plus Rituximab in Comparison With no Maintenance Therapy|
|Actual Study Start Date :||December 2004|
|Actual Primary Completion Date :||May 2007|
|Actual Study Completion Date :||December 2016|
Experimental: A : rituximab maintenance
Maintenance with rituximab for 2 years
rituximab 375 mg/m2 every 8 weeks for 24 months (12 injections) or control with no treatment
No Intervention: B : no maintenance
No further treatment
- Progression Free Survival (PFS) [ Time Frame: number of event observed driven : 344 events or 10 years ]defined as the time from randomization to progression, relapse, death from any cause.
- Response rates, event driven survival endpoints (EFS, PFS, OS) [ Time Frame: number of event observed driven : 344 events or 10 years ]
- Quality of life [ Time Frame: number of event observed driven : 344 events or 10 years ]
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): NCT00140582
|Principal Investigator:||Gilles A Salles, MD PhD||Lymphoma Study Association|