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Rituximab, Bortezomib,Bendamustine , Dexamethasone, Patients With Mantle Cell Lymphoma

NCT00740415 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2016-03-16

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

rituximab

Rituximab, 375 mg/m2 Intraveinous

DRUG

bortezomib

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

DRUG

dexamethasone

day - Dexamethasone, 40 mg Intraveinous

DRUG

Bendamustine

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

Sponsors & Collaborators

  • Janssen, LP

    collaborator INDUSTRY

  • Mundipharma Pte Ltd.

    collaborator INDUSTRY

  • French Innovative Leukemia Organisation

    lead OTHER

Principal Investigators

  • Remy Gressin, MD · CHU de Grenoble - Hopital de la Tronche

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
65 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2011-05-31
Completion
2015-08-31

Countries

  • France

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00740415 on ClinicalTrials.gov