Clinical trial NCT01457144: Study of Mantle Cell Lymphoma Treatment by RiBVD
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 Cannot or Refuse Receive Conditioning Regimen Followed by Autograft
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Mantle Cell Lymphoma
Keywords: Mantle cell lymphoma
Rituximab
bendamustine
Velcade
Dexamethasone
Lead sponsor: French Innovative Leukemia Organisation
Sponsor class: OTHER
Collaborators: name: Lymphoma Study Association
name: Janssen-Cilag Ltd.
name: Mundipharma Pte Ltd.
name: Roche Pharma AG
name: Chugai Pharma Europe Ltd.
First posted: 2011-10-21
Enrollment: 76
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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 cannot 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

Eligibility 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

Primary outcomes:
measure: Improvement of progression-free survival (PFS)
timeFrame: 18 months
Secondary outcomes:
measure: Overall and complete response rate after 4 cures and 6 cures
timeFrame: 6 months
measure: Residual disease evaluated by molecular biology
timeFrame: 6 years
measure: Intermediate response predictive factors study
timeFrame: 4 months
measure: Toxicity of RiBVD regimen according to NCI criteria Hematological and non-hematological toxicity
timeFrame: 6 months
measure: Prognosis value on Overall survival and progression free survival and on duration of response, of the MIPI index, MIPIb index and goelams index
timeFrame: 36 months
measure: Residual disease evaluated by molecular biology Q-PCR on blood and bone marrow, by Hybridation Fluorescente In Situ and Flow cytometry on blood cells
timeFrame: 42 months
measure: Diagnostic PET scan results, at intermediate and final analysis
timeFrame: 4 and 6 months
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Valerie ROLLAND NEYRET
Study officials:
affiliation: Groupe Est Ouest des Leucémies et autres Maladies du Sand
name: Rémy GRESSIN, MD
role: PRINCIPAL_INVESTIGATOR
References: