Groupe d'Etude des Lymphomes de l'Adulte     Etude de phase III randomisée, multicentrique, internationale, en ouvert.     Etude multicentrique, de phase III, randomisée en ouvert, visant à évaluer le bénéfice d'un traitement d'entretien par Rituximab par rapport à l'absence de traitement d'entretien chez des patients atteints d'un lymphome folliculaire de stade avancé ayant répondu à un traitement d'induction par chimiothérapie + Rituximab.

STUDY INFOS

Study Coordinator Professeur Gilles SALLES gilles.salles@chu-lyon.fr Professeur Luc XERRI xerril@marseille.fnclcc.fr Clinical Project Leader Delphine GERMAIN delphine.germain@gelarc.org Marion FOURNIER marion.fournier@gelarc.org Data Project Leader Laurence GIRARD laurence.girard@gelarc.org Head of PV Larissa MEGE larissa.mege@gelarc.org             Ethic committee approval : Yes  (Lyon B 17/09/2004) Onset date : 16/12/2004 End date : 31/03/2007 Recruitment duration : 2  year(s) First recruitment : Last recruitment : Number of patient : 1217 Monitoring : Yes

LAST NEWS

PUBLICATION: http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2810%2962175-7/fulltext EMA,Swissmedic and FDA have approved the use of MabThera (rituximab) as maintenance therapy for patients suffering from follicular lymphoma (FL). See details in Newsletter 15

STUDY DOCUMENTS

Protocol v 4.0 16/08/2006 Download Protocol v 5.0 28/02/2008 Download protocol v 5.1 04/12/2008 Download SAE Form 21/11/2006 Download Monitoring guidelines_Initial CRF 16/02/2007 Download Monitoring guidelines_new CRF 16/02/2007 Download Monitoring_Top Level Plan 16/02/2007 Download Monitoring guidelines_v3 30/07/2008 Download Financial disclosure form v4.0 26/01/2011 Download

RECRUITMENT

Global registered patients 20/04/2007 Download

RECRUITMENT STATUS ON : 17/05/2012

Number of enrolled patients : 1217 / 1217

PHARMACOVIGILANCE

line listing 19/10/2010 Download Prima Safety Report_2010 18/01/2011 Download SUSARs_PRIMA 18/04/2011 Download

MEETINGS

Prague - 12 September 2004 12/09/2004 Download Lugano - 8 June 2005 08/06/2005 Download Amsterdam - 16 June 2006 16/06/2006 Download Orlando - 9 December 2006 1/2 09/12/2006 Download Orlando - 9 December 2006 2/2 09/12/2006 Download Vienna - 7 June 2007 07/06/2007 Download

NEWS LETTERS

1st Newsletter 12/05/2005 Download 2nd Newsletter 30/12/2005 Download 3th Newsletter 12/07/2006 Download 3th Newsletter 12/07/2006 Download 4th Newsletter 04/08/2006 Download 5th Newsletter 08/01/2007 Download 6th Newsletter 08/03/2007 Download 7th Newsletter 30/04/2007 Download 1st Monitor Newsletter 15/10/2007 Download 8th Newsletter 15/10/2007 Download 2nd Monitors Newsletter 30/01/2008 Download 9th Newsletter 30/01/2008 Download 10th Newsletter 01/07/2008 Download 11th Newsletter 10/02/2009 Download 12th Newsletter 24/08/2009 Download Investigator letter 16/09/2009 Download 13th Newsletter 22/12/2009 Download 14th Newsletter 27/07/2010 Download 15th Newsletter 22/11/2010 Download