NCT01457144

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2011

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

October 20, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 21, 2011

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

March 16, 2016

Status Verified

March 1, 2016

Enrollment Period

2.9 years

First QC Date

October 20, 2011

Last Update Submit

March 15, 2016

Conditions

Mantle Cell Lymphoma

Keywords

Mantle cell lymphomaRituximabbendamustineVelcadeDexamethasone

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (7)

  • Overall and complete response rate after 4 cures and 6 cures

    6 months

  • Residual disease evaluated by molecular biology

    6 years

  • Intermediate response predictive factors study

    4 months

  • Toxicity of RiBVD regimen according to NCI criteria Hematological and non-hematological toxicity

    6 months

  • 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

  • +2 more secondary outcomes

Study Arms (1)

RiBVD

EXPERIMENTAL

Rituximab Bendamustine Velcade® Dexamethasone 6 cycles every 28 days

Drug: RiBVD

Interventions

RiBVDDRUG

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

RiBVD

Eligibility Criteria

Age65 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • mantle cell Lymphoma CD20 positive
  • Untreated patients
  • 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 .

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Valerie ROLLAND NEYRET

Grenoble, 38043, France

Location

Related Links

MeSH Terms

Conditions

Lymphoma, Mantle-Cell

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Rémy GRESSIN, MD

    Groupe Est Ouest des Leucémies et autres Maladies du Sand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2011

First Posted

October 21, 2011

Study Start

October 1, 2011

Primary Completion

September 1, 2014

Study Completion

March 1, 2016

Last Updated

March 16, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)