Study of Mantle Cell Lymphoma Treatment by RiBVD

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2016-03-31

Brief Summary

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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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Detailed Description

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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

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Mantle Cell Lymphoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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RiBVD

Rituximab Bendamustine Velcade® Dexamethasone 6 cycles every 28 days

Group Type EXPERIMENTAL

RiBVD

Intervention Type 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

Interventions

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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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

65 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No