Study of Mantle Cell Lymphoma Treatment by RiBVD (RIBVD)

French Innovative Leukemia Organisation

Status and phase

Completed

Phase 2

Conditions

Mantle Cell Lymphoma

Treatments

Drug: RiBVD

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01457144

Manteau RiBVD

Details and patient eligibility

About

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.

Full 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

Enrollment

76 patients

Sex

All

Ages

65 to 85 years old

Volunteers

No 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