Manteau 2007 SJ "LYMA" "Randomized, Open-label, Phase III Study Efficacy of Rituximab Maintenance Therapy in Patients 18 to 65 Years , First-line Treatment for MCL
Demonstration of the superiority in terms of 4-year event-free survival (EFS) of Rituximab
maintenance therapy compared to post-autograft surveillance in patients aged 18-65 years
inclusive, treated with R-DHAP then autologous transplantation for MCL as first-line
therapy.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
event-free survival (EFS) post Rituximab maintenance therapy
EFS post 4 years after maintenance
Yes
Steven LE GOUILL, MD
Principal Investigator
Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Manteau 2007 SJ "LYMA"
NCT00921414
September 2008
August 2012
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