NCT00740415

Brief Summary

RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as doxorubicin, dexamethasone, and chlorambucil, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving combination chemotherapy together with rituximab and bortezomib may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving rituximab together with bortezomib, doxorubicin, dexamethasone, and chlorambucil works as first-line therapy in treating older patients with stage II, stage III, or stage IV mantle cell lymphoma.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
39

participants targeted

Target at P25-P50 for phase_2 lymphoma

Timeline
Completed

Started Jun 2007

Typical duration for phase_2 lymphoma

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

June 1, 2007

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 22, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 25, 2008

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
4.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

March 16, 2016

Status Verified

March 1, 2016

Enrollment Period

3.9 years

First QC Date

August 22, 2008

Last Update Submit

March 15, 2016

Conditions

Lymphoma

Keywords

contiguous stage II mantle cell lymphomanoncontiguous stage II mantle cell lymphomastage III mantle cell lymphomastage IV mantle cell lymphoma

Outcome Measures

Primary Outcomes (1)

  • Overall response rate after 4 courses of therapy

    4 months

Study Arms (1)

ARM RiBVD

EXPERIMENTAL

RiBVD 6 cycles every 28 days day 1 : * Rituximab /Mabthera®, 375 mg/m2 en IV * Bendamustine, 90 mg/m2 en IVD * Bortezomib/Velcade®, 1,3 mg/m2 en IVD day 2 : - Bendamustine, 90 mg/m2 en IVD * Dexamethasone, 40 mg IV day 4 : - Bortezomib/Velcade®, 1,3 mg/m2 en IVD day 8 : - Bortezomib/Velcade®, 1,3 mg/m2 en IVD day 11 : - Bortezomib/Velcade®, 1,3 mg/m2 en IVD

Biological: rituximabDrug: bortezomibDrug: dexamethasoneDrug: Bendamustine

Interventions

rituximabBIOLOGICAL

Rituximab, 375 mg/m2 Intraveinous

Also known as: Mabthera ®,
ARM RiBVD
bortezomibDRUG

-Velcade®, 1,3 mg/m2 Intraveinous on days 1, 4, 8 and 11

Also known as: Velcade
ARM RiBVD
dexamethasoneDRUG

day - Dexamethasone, 40 mg Intraveinous

ARM RiBVD
BendamustineDRUG

-Day 1 and day 2 Bendamustine/Levact ®,, 90 mg/m2 Intraveinous

Also known as: Levact ®
ARM RiBVD

Eligibility Criteria

Age65 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
DISEASE CHARACTERISTICS: * Diagnosis of mantle cell lymphoma * Stage II-IV disease * No neuromeningeal disease PATIENT CHARACTERISTICS: * WHO performance status 0-2 * No prior cancer except for carcinoma in situ of the cervix or basal cell skin cancer * LVEF \> 50% * HIV-negative * Hepatitis B- and C-negative * No hepatocellular, renal, or bone marrow insufficiency unrelated to lymphoma PRIOR CONCURRENT THERAPY: * Not specified

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

CHU de Grenoble - Hopital Michallon

Grenoble, 38043, France

Location

Related Links

MeSH Terms

Conditions

LymphomaLymphoma, Mantle-Cell

Interventions

RituximabBortezomibDexamethasoneBendamustine Hydrochloride

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, Non-Hodgkin

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsBoronic AcidsAcids, NoncarboxylicAcidsInorganic ChemicalsBoron CompoundsOrganic ChemicalsPyrazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedButyratesAcids, AcyclicCarboxylic AcidsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Remy Gressin, MD

    CHU de Grenoble - Hopital de la Tronche

    STUDY CHAIR

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

August 22, 2008

First Posted

August 25, 2008

Study Start

June 1, 2007

Primary Completion

May 1, 2011

Study Completion

August 1, 2015

Last Updated

March 16, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)