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Completed

NCT Number: NCT01457144

Study of Mantle Cell Lymphoma Treatment by RiBVD

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.

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Key information

Age range

65 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Valerie ROLLAND NEYRET

Grenoble, 38043, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RiBVD

Drug

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 outcomes

  1. Improvement of progression-free survival (PFS)

    Time frame: 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 outcomes

  1. Overall and complete response rate after 4 cures and 6 cures

    Time frame: 6 months

    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

  2. Residual disease evaluated by molecular biology

    Time frame: 6 years

    Residual disease evaluated by molecular biology on blood and bone marrow, by Hybridation Fluorescente In Situ and Flow cytometry on blood cells

  3. Intermediate response predictive factors study

    Time frame: 4 months

    Predictive factors are determined at diagnosis are watched at Intermediate response

  4. Toxicity of RiBVD regimen according to NCI criteria Hematological and non-hematological toxicity

    Time frame: 6 months

    Toxicities are collected at every course = every 28 days during 6 months

  5. 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

  6. 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

    blood and bone marrow samples sent to central laboratory for molecular residual disease at diagnosis, treatment evaluation and follow-up

  7. Diagnostic PET scan results, at intermediate and final analysis

    Time frame: 4 and 6 months

    Pet scan results at intermediate analysis = 4 months Pet scan results at final analysis = 6 months

Sponsors and collaborators

Lead sponsor

French Innovative Leukemia Organisation

Other

Collaborators

  • Chugai Pharma Europe Ltd.
  • Janssen-Cilag Ltd.
  • Lymphoma Study Association
  • Mundipharma Pte Ltd.
  • Roche Pharma AG

Registry information

Official study 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

Acronym: RIBVD

Important dates

Study start
2011
Primary completion
2014
Study completion
2016
First posted
Oct 21, 2011
Registry last updated
Mar 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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