Recent Updates
Recently added Catalysts

RiBVD

Phase 2

Mantle Cell Lymphoma | Small molecule | Other |Roche Holding AG|Trials Updated: Mar 16, 2016

RiBVD development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since Oct 2011

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment76

FDA Designations

No designations recorded

RiBVD clinical trials

RiBVD · 1 trial · 1 indication

Phase 2 1
NCT01457144Study of Mantle Cell Lymphoma Treatment by RiBVDMantle Cell Lymphoma
COMPLETED76 Analytics
PHASE2COMPLETED
Study of Mantle Cell Lymphoma Treatment by RiBVD
Mantle Cell LymphomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Improvement of progression-free survival (PFS)
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

Secondary Endpoints

Overall and complete response rate after 4 cures and 6 cures
6 months
Residual disease evaluated by molecular biology
6 years
Intermediate response predictive factors study
4 months
Unlock Study Endpoints

Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
RiBVDEXPERIMENTALRituximab Bendamustine Velcade® Dexamethasone 6 cycles every 28 days

Interventions

NameTypeDescription
RiBVDDRUGEvery 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
Unlock Study Design Details

Eligibility Criteria

Age Range65 Years to 85 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * mantle cell Lymphoma CD20 positive * Untreated patients * 65 ans years old patients or 18 to 65 years old patients who can't or refuse receive conditioning regimen followed by autograft. * Stages Ann Arbor II, III or IV, * ECOG performance status of 0, 1 or 2 * Without history...

Countries:France
Unlock Eligibility Criteria