Study of Mantle Cell Lymphoma Treatment by RiBVD (RIBVD)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2011 by Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS
Sponsor:
Collaborators:
Lymphoma Study Association
Janssen-Cilag Ltd.
Mundipharma Pte Ltd.
Roche Pharma AG
Chugai Pharma Europe Ltd.
Information provided by (Responsible Party):
Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS
ClinicalTrials.gov Identifier:
NCT01457144
First received: October 20, 2011
Last updated: July 24, 2013
Last verified: October 2011
  Purpose

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 can't or refuse receive conditioning regimen followed by autograft.


Condition Intervention Phase
Mantle Cell Lymphoma
Drug: RiBVD
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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 Can't or Refuse Receive Conditioning Regimen Followed by Autograft

Resource links provided by NLM:


Further study details as provided by Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS:

Primary Outcome Measures:
  • Improvement of progression-free survival (PFS) [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Pet scan results at intermediate analysis = 4 months Pet scan results at final analysis = 6 months


Estimated Enrollment: 76
Study Start Date: October 2011
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RiBVD
Rituximab Bendamustine Velcade® Dexamethasone 6 cycles every 28 days
Drug: RiBVD

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

Other Name: RiBVD

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

  Eligibility

Ages Eligible for Study:   65 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01457144

Contacts
Contact: Rémy GRESSIN, MD + 33 (0)76 76 53 33 rgressin@chu-grenoble.fr
Contact: Valerie ROLLAND NEYRET, Mrs + 33 (0)76 76 50 96 Vrolland-neyret@chu-grenoble.fr

Locations
France
Valerie ROLLAND NEYRET Recruiting
Grenoble, France, 38043
Contact: Rémy GRESSIN, MD    +33 (0)4 76 76 53 33    rgressin@chu-grenoble.fr   
Contact: Valérie ROLLAND NEYRET, Mrs    +33 (0)4 76 76 50 96    Vrolland-neyret@chu-grenoble.fr   
Sponsors and Collaborators
Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS
Lymphoma Study Association
Janssen-Cilag Ltd.
Mundipharma Pte Ltd.
Roche Pharma AG
Chugai Pharma Europe Ltd.
Investigators
Principal Investigator: Rémy GRESSIN, MD Groupe Est Ouest des Leucémies et autres Maladies du Sand
  More Information

Additional Information:
No publications provided

Responsible Party: Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS
ClinicalTrials.gov Identifier: NCT01457144     History of Changes
Other Study ID Numbers: Manteau RiBVD
Study First Received: October 20, 2011
Last Updated: July 24, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS:
Mantle cell lymphoma
Rituximab
bendamustine
Velcade
Dexamethasone

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Mantle-Cell
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Bendamustine
Dexamethasone
Alkylating Agents
Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014