Study of First line mantle cell lymphoma treatment by Rituximab, Velcade, Bendamustine and Dexamethasone schema in patients older than 65 years or 18 to 65 years old who cannot or refuse receive conditioning regimen followed by autograft.
Demonstration of Improvement of progression-free survival (PFS) compared to literature data. 6 months prolongation equal 24 months compared to 18 months obtained whatever the current regimen and in particular compared to RCHOP regimen
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
76
Every cycle: Rituximab intravenous infusion dosage 375 mg/m² day 1 Bendamustine direct intervenous 90 mg/m² day 1 and day 2 Velcade®subcutaneous 1,3 mg/m² day 1,4, 8 and 11 dexamethasone 40 mg IVD on day 2
Valerie ROLLAND NEYRET
Grenoble, France
Improvement of progression-free survival (PFS)
Improvement of progression-free survival (PFS) compared to litterature data 6 months prolongation 24 months compared to 18 months obtained whatever the current regimen and in particular compared to RCHOP regimen in reference with Lenz JCO 2005
Time frame: 18 months
Overall and complete response rate after 4 cures and 6 cures
Overall and complete response rate after 4 cures equal intermediate response and after 6 cures equal final response according to Cheson 1999 criteria without Positron Emission Tomography and 2007 with Positron Emission Tomography
Time frame: 6 months
Residual disease evaluated by molecular biology
Residual disease evaluated by molecular biology on blood and bone marrow, by Hybridation Fluorescente In Situ and Flow cytometry on blood cells
Time frame: 6 years
Intermediate response predictive factors study
Predictive factors are determined at diagnosis are watched at Intermediate response
Time frame: 4 months
Toxicity of RiBVD regimen according to NCI criteria Hematological and non-hematological toxicity
Toxicities are collected at every course = every 28 days during 6 months
Time frame: 6 months
Prognosis value on Overall survival and progression free survival and on duration of response, of the MIPI index, MIPIb index and goelams index
Time frame: 36 months
Residual disease evaluated by molecular biology Q-PCR on blood and bone marrow, by Hybridation Fluorescente In Situ and Flow cytometry on blood cells
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blood and bone marrow samples sent to central laboratory for molecular residual disease at diagnosis, treatment evaluation and follow-up
Time frame: 42 months
Diagnostic PET scan results, at intermediate and final analysis
Pet scan results at intermediate analysis = 4 months Pet scan results at final analysis = 6 months
Time frame: 4 and 6 months