Study of Mantle Cell Lymphoma Treatment by RiBVD
Conditions
Mantle Cell Lymphoma
Conditions: official terms
Lymphoma - Lymphoma, Mantle-Cell
Conditions: Keywords
Mantle cell lymphoma, Rituximab, bendamustine, Velcade, Dexamethasone
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: RiBVD
Type: Drug
Overall Status
Recruiting
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 can't 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
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 85 Years
Minimum Age: 65 Years
Gender: Both
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
Location
Valerie ROLLAND NEYRET
Grenoble, France
Status: Recruiting
Contact: Rémy GRESSIN, MD - +33 (0)4 76 76 53 33 - rgressin@chu-grenoble.fr
Start Date
October 2011
Completion Date
April 2018
Sponsors
Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS
Source
Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page