CompletedNCT01457144RIBVDUpdated Mar 16, 2016

Study of Mantle Cell Lymphoma Treatment by RiBVD

A Phase 2 interventional study of RiBVD in Mantle Cell Lymphoma, sponsored by French Innovative Leukemia Organisation. Completed at 1 site in France. Open to participants aged 65 Years to 85 Years. Per ClinicalTrials.gov, last updated 2016-03-16.

Sponsored by French Innovative Leukemia Organisation · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 76
Allocation: Not applicable
Ages: 65 Years to 85 Years
Sex: All

Study 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.

Read the detailed description

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

Conditions studied

Mantle Cell Lymphoma

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Keywords

Mantle cell lymphoma
Rituximab
bendamustine
Velcade
Dexamethasone

In context

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's enrollment of 76 is above the median of 40 across 4,509 interventional studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

French Innovative Leukemia Organisation is the lead sponsor of 57 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 65 Years to 85 Years
Sexes eligible: All
Accepts healthy volunteers: No

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 of neoplasm, except in situ cervix carcinoma and cutaneous basal cell epithelioma, or in complete remission since 3 years,
Without drug contraindication used in the schema (Rituximab, benda-mustine, Velcade, Dexamethasone),
Without heart insufficiency or stabilized,
With the following biological values limits except if pathological values are due to Medullary invading or hypersplenism, hepatic involvement) :PNN more than 1 G/L, Platelets more than 50 G/L,Transaminases (SGOT and SGPT) and alkalin phosphatases alcalines less than 4 x normal,Bilirubin less than 3 x N,- Clearance creatinemia more than 20 mL/min
Hepatitis B negative serology unless the seropositivity is clearly linked to a vaccination.
Can be regularly followed
Who signed the informed consent,
Affiliated to a national insurance or such a same scheme .

Exclusion criteria

Exclusion Criteria:

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
Non stable diabetes,
HIV positive or active hepatitis C or B
ECOG performance status equal or more than 3
Peripheral neuropathy, whatever its origin, rated more than 2 from NCI
Non stabilized heart insufficiency,
Patient who can't receive hyperhydration in order to treat tumoral lysis syndrome or in prophylaxis,
Patient who can't, whatever the reason, be regularly followed,
Major patient who are on legal protection, or can't give their consent
Patient who has not signed the informed consent

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 76 participants (actual)

Study arms

Experimental
RiBVD
Rituximab Bendamustine Velcade® Dexamethasone 6 cycles every 28 days
Drug: RiBVD

Interventions

DrugRiBVD
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

What researchers measure

Primary outcomes

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

Secondary outcomes

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
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

Study locations

1 site

Valerie ROLLAND NEYRET
Grenoble, 38043, France

References and documents

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 16, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01457144
Lead sponsor: French Innovative Leukemia Organisation
Collaborators: Lymphoma Study Association, Janssen-Cilag Ltd., Mundipharma Pte Ltd., Roche Pharma AG, Chugai Pharma Europe Ltd.
Responsible party: Sponsor
First posted: Oct 21, 2011
Start date: Oct 2011
Primary completion: Sep 2014
Completion: Mar 2016
Last update: Mar 16, 2016

Study contacts

Rémy GRESSIN, MD

principal investigator · Groupe Est Ouest des Leucémies et autres Maladies du Sand

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.

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