Mantel Cell Lymphoma Efficacy of Rituximab Maintenance

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

Randomized, open-label, phase III study to evaluate the efficacy of rituximab maintenance therapy in patients aged between 18 and 65 years inclusive undergoing first-line treatment for mantle cell lymphoma and exhibiting a response after autologous transplantation.

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.

Inclusion Criteria:

• mantle cell lymphoma
• Initial immunophenotyping with CD20 and CD5.
• CD20+.
• t (11;14) by karyote, FISH, molecular biology or immunohistochemistry (Bcl-1)
• Patient no previous treated.
• At least one tumor site accessible for assessment
• Aged > 18 years < 65
• ECOG < or = 2.
• No other neoplasms apart from resected basal cell carcinoma or in situ carcinoma.
• signed informed consent
• FEVG 50%

Exclusion Criteria:

• other type of lymphoma
• ECOG > or = 3
• relapse
• serology VIH + Hepatite +
• diabetis