Completed
RIBVDFirst 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 Followed by Autograft
What is being tested
RiBVD
Drug
Who is being recruted
Hemic and Lymphatic Diseases+7
+ Immune System Diseases
+ Immunoproliferative Disorders
From 65 to 85 Years
+26 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 2
Interventional
Study Start: October 2011
Summary
Principal SponsorFrench Innovative Leukemia Organisation
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: October 1, 2011
Actual date on which the first participant was enrolled.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
Official TitleFirst 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 Followed by Autograft
Principal SponsorFrench Innovative Leukemia Organisation
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
76 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 65 to 85 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Hemic and Lymphatic DiseasesImmune System DiseasesImmunoproliferative DisordersLymphatic DiseasesLymphomaLymphoma, Non-HodgkinLymphoproliferative DisordersNeoplasmsNeoplasms by Histologic TypeLymphoma, Mantle-Cell
Criteria
13 inclusion criteria required to participate
Who signed the informed consent,
Without heart insufficiency or stabilized,
mantle cell Lymphoma CD20 positive
Untreated patients
Show More Criteria
13 exclusion criteria prevent from participating
Other type of lymphoma than mantle cell lymphoma according to OMS 2008 classification
Patients in relapse, except those in relapse due to localized stade who only received locoregional irradiation or splenectomized,
Central nervous system localization in particular meninge,
Drug used in the schema contraindication Rituximab , Bendamustine , Velcade® or Dexamethasone
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalRituximab Bendamustine Velcade® Dexamethasone 6 cycles every 28 days
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Suspended
CompletedOne Study Center