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Study of Mantle Cell Lymphoma Treatment by RiBVD (RIBVD)

Primary Purpose

Mantle Cell Lymphoma

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
RiBVD
Sponsored by
French Innovative Leukemia Organisation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mantle Cell Lymphoma focused on measuring Mantle cell lymphoma, Rituximab, bendamustine, Velcade, Dexamethasone

Eligibility Criteria

65 Years - 85 Years (Older Adult)All SexesDoes not accept healthy volunteers

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:

  • 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

Sites / Locations

  • Valerie ROLLAND NEYRET

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

RiBVD

Arm Description

Rituximab Bendamustine Velcade® Dexamethasone 6 cycles every 28 days

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
Intermediate response predictive factors study
Predictive factors are determined at diagnosis are watched at Intermediate response
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
Prognosis value on Overall survival and progression free survival and on duration of response, of the MIPI index, MIPIb index and goelams index
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
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

Full Information

First Posted
October 20, 2011
Last Updated
March 15, 2016
Sponsor
French Innovative Leukemia Organisation
Collaborators
Lymphoma Study Association, Janssen-Cilag Ltd., Mundipharma Pte Ltd., Roche Pharma AG, Chugai Pharma Europe Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01457144
Brief Title
Study of Mantle Cell Lymphoma Treatment by RiBVD
Acronym
RIBVD
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 Followed by Autograft
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
French Innovative Leukemia Organisation
Collaborators
Lymphoma Study Association, Janssen-Cilag Ltd., Mundipharma Pte Ltd., Roche Pharma AG, Chugai Pharma Europe Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mantle Cell Lymphoma
Keywords
Mantle cell lymphoma, Rituximab, bendamustine, Velcade, Dexamethasone

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RiBVD
Arm Type
Experimental
Arm Description
Rituximab Bendamustine Velcade® Dexamethasone 6 cycles every 28 days
Intervention Type
Drug
Intervention Name(s)
RiBVD
Intervention Description
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
Primary Outcome Measure Information:
Title
Improvement of progression-free survival (PFS)
Description
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 Outcome Measure Information:
Title
Overall and complete response rate after 4 cures and 6 cures
Description
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
Title
Residual disease evaluated by molecular biology
Description
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
Title
Intermediate response predictive factors study
Description
Predictive factors are determined at diagnosis are watched at Intermediate response
Time Frame
4 months
Title
Toxicity of RiBVD regimen according to NCI criteria Hematological and non-hematological toxicity
Description
Toxicities are collected at every course = every 28 days during 6 months
Time Frame
6 months
Title
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
Title
Residual disease evaluated by molecular biology Q-PCR on blood and bone marrow, by Hybridation Fluorescente In Situ and Flow cytometry on blood cells
Description
blood and bone marrow samples sent to central laboratory for molecular residual disease at diagnosis, treatment evaluation and follow-up
Time Frame
42 months
Title
Diagnostic PET scan results, at intermediate and final analysis
Description
Pet scan results at intermediate analysis = 4 months Pet scan results at final analysis = 6 months
Time Frame
4 and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rémy GRESSIN, MD
Organizational Affiliation
Groupe Est Ouest des Leucémies et autres Maladies du Sand
Official's Role
Principal Investigator
Facility Information:
Facility Name
Valerie ROLLAND NEYRET
City
Grenoble
ZIP/Postal Code
38043
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://www.filo-leucemie.org
Description
FILO internet site

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Study of Mantle Cell Lymphoma Treatment by RiBVD

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