Clinical Trial: Study of Mantle Cell Lymphoma Treatment by RiBVD

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: First Line Mantle Cell Lymphoma (MCL) Treatment by RiBVD Schema in Patients Older Than 65 Years or 18 to 65 Years Old Who Cannot or Refuse Receive Conditioning Regimen Fol

Brief Summary: 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.

Detailed Summary: 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
Sponsor: French Innovative Leukemia Organisation

Current Primary Outcome: Improvement of progression-free survival (PFS) [ Time Frame: 18 months ]

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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Overall and complete response rate after 4 cures and 6 cures [ Time Frame: 6 months ]
    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
  • Residual disease evaluated by molecular biology [ Time Frame: 6 years ]
    Residual disease evaluated by molecular biology on blood and bone marrow, by Hybridation Fluorescente In Situ and Flow cytometry on blood cells
  • Intermediate response predictive factors study [ Time Frame: 4 months ]
    Predictive factors are determined at diagnosis are watched at Intermediate response
  • Toxicity of RiBVD regimen according to NCI criteria Hematological and non-hematological toxicity [ Time Frame: 6 months ]
    Toxicities are collected at every course = every 28 days during 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 [ Time Frame: 42 months ]
    blood and bone marrow samples sent to central laboratory for molecular residual disease at diagnosis, treatment evaluation and follow-up
  • Diagnostic PET scan results, at intermediate and final analysis [ Time Frame: 4 and 6 months ]
    Pet scan results at intermediate analysis = 4 months Pet scan results at final analysis = 6 months


Original Secondary Outcome:

  • Overall and complete response rate after 4 cures and 6 cures [ Time Frame: 6 months ]
    Overall and complete response rate after 4 cures equal intermediate response and after 6 cures equal final response according to Cheson 1999 citeria without Positron Emission Tomography and 2007 with Positron Emission Tomography
  • Residual disease evaluated by molecular biology [ Time Frame: 6 years ]
    Residual disease evaluated by molecular biology on blood and bone marrow, by Hybridation Fluorescente In Situ and Flow cytometry on blood cells


Information By: French Innovative Leukemia Organisation

Dates:
Date Received: October 20, 2011
Date Started: October 2011
Date Completion:
Last Updated: March 15, 2016
Last Verified: March 2016