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

TRIAL POSITIVE The independant PRIMA data safety monitoring comittee (DSMC) met on september 15th to examine the results of the interim analysis. The committe declared that the primary objective of the study (improvement of PFS by 45% in patients receiving rituximab maintenance) has been met. The results will be submitted for presentation at an upcoming sceintific meeting.

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 IB 11th Edition 07/11/2006 Download IB 12th Edition 12/01/2007 Download IB 13th Edition 14/03/2008 Download IB 14th Edition 31/10/2008 Download Financial disclosure form v3 09/11/2009 Download

RECRUITMENT

Global registered patients 20/04/2007 Download

RECRUITMENT STATUS ON : 04/09/2010

Number of enrolled patients : 1217 / 1217

PHARMACOVIGILANCE

SUSAR PRIMA 03/12/2009 Download line listing 19/10/2010 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