Study of Mantle Cell Lymphoma Treatment by RiBVD

Mantle Cell Lymphoma Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01457144
• Other study ID #: Manteau RiBVD
• Status: Completed
• Phase: Phase 2
• First received: October 20, 2011
• Last updated: March 15, 2016
• Start date: October 2011
• Est. completion date: March 2016

Study information

• Verified date: March 2016
• Source: French Innovative Leukemia Organisation
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: March 2016
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years to 85 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Mantle-Cell
• Mantle Cell Lymphoma

Intervention

Drug:
• 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

Locations

Country	Name	City	State
France	Valerie ROLLAND NEYRET	Grenoble

Sponsors (6)

Lead Sponsor	Collaborator
French Innovative Leukemia Organisation	Chugai Pharma Europe Ltd., Janssen-Cilag Ltd., Lymphoma Study Association, Mundipharma Pte Ltd., Roche Pharma AG

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of progression-free survival (PFS)	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	18 months	Yes
Secondary	Overall and complete response rate after 4 cures and 6 cures	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	6 months	Yes
Secondary	Residual disease evaluated by molecular biology	Residual disease evaluated by molecular biology on blood and bone marrow, by Hybridation Fluorescente In Situ and Flow cytometry on blood cells	6 years	No
Secondary	Intermediate response predictive factors study	Predictive factors are determined at diagnosis are watched at Intermediate response	4 months	Yes
Secondary	Toxicity of RiBVD regimen according to NCI criteria Hematological and non-hematological toxicity	Toxicities are collected at every course = every 28 days during 6 months	6 months	Yes
Secondary	Prognosis value on Overall survival and progression free survival and on duration of response, of the MIPI index, MIPIb index and goelams index		36 months	Yes
Secondary	Residual disease evaluated by molecular biology Q-PCR on blood and bone marrow, by Hybridation Fluorescente In Situ and Flow cytometry on blood cells	blood and bone marrow samples sent to central laboratory for molecular residual disease at diagnosis, treatment evaluation and follow-up	42 months	Yes
Secondary	Diagnostic PET scan results, at intermediate and final analysis	Pet scan results at intermediate analysis = 4 months Pet scan results at final analysis = 6 months	4 and 6 months	Yes

External Links

•   FILO internet site