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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
299
2 months after ASCT maintenance treatment with Rituximab 500mg/m² IV every 2 months during 3 years
No treatment patient follow-up every 2 months during 3 years
Regional University Hospital
Nantes, France
event-free survival (EFS) post Rituximab maintenance therapy
Time frame: EFS post 4 years after maintenance
duration of PFS of the entire group of patients.
Time frame: Safety/efficacy of maintenance treatment
duration of OS of the entire group of patients
Time frame: safety/efficacy of treatment
complete, partial and overall response rate after induction with R-DHAP and after ASCT.
Time frame: safety/efficacy of all the treatment
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