Rituximab, Bortezomib,Bendamustine , Dexamethasone, Patients With Mantle Cell Lymphoma (ManteauRiBVD)

March 15, 2016 updated by: French Innovative Leukemia Organisation

First-line Treatment of Mantle Cell Lymphoma of Old Patients . Evaluate the Efficacy, Toxicity, and Molecular Prognostic Factors of Velcade®) in Association With Chemotherapy and Immunotherapy With Rituximab

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

Primary

  • Evaluate the efficacy of rituximab, bortezomib, doxorubicin hydrochloride, dexamethasone, and chlorambucil as first-line therapy in patients with stage II-IV mantle cell lymphoma.

Secondary

  • Determine the complete response rate in these patients.
  • Determine the efficacy, in terms of complete and overall response, by F18 fludeoxyglucose scan.
  • Determine overall, disease-free, and event-free survival of these patients.
  • Assess tolerability of this regimen in these patients.
  • Evaluate the impact of factors, described in previous protocols, on response to therapy and survival.
  • Assess the impact of residual disease in cerebrospinal fluid on survival.

OUTLINE: This is a multicenter study.

Patients receive rituximab IV on day 1 (days 1 and 8 of the first course only); bortezomib IV on days 1, 4, 8, and 11; doxorubicin hydrochloride IV continuously over 24 hours on days 1-4; dexamethasone IV on days 1-4; and oral chlorambucil on days 20-29. Treatment repeats every 5 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.

Patients who achieve at least 50% response receive 2 additional courses of therapy.

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Grenoble, France, 38043
        • CHU de Grenoble - Hôpital Michallon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 80 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ARM RiBVD

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: rituximab
Rituximab, 375 mg/m2 Intraveinous
Other Names:
  • Mabthera ®,
Drug: bortezomib
-Velcade®, 1,3 mg/m2 Intraveinous on days 1, 4, 8 and 11
Other Names:
  • Velcade
Drug: dexamethasone
day - Dexamethasone, 40 mg Intraveinous
Drug: Bendamustine
-Day 1 and day 2 Bendamustine/Levact ®,, 90 mg/m2 Intraveinous
Other Names:
  • Levact ®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall response rate after 4 courses of therapy
Time Frame: 4 months
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

French Innovative Leukemia Organisation

Collaborators

Mundipharma Pte Ltd.
Janssen, LP

Investigators

  • Study Chair: Remy Gressin, MD, CHU de Grenoble - Hopital de la Tronche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

August 22, 2008

First Submitted That Met QC Criteria

August 22, 2008

First Posted (Estimate)

August 25, 2008

Study Record Updates

Last Update Posted (Estimate)

March 16, 2016

Last Update Submitted That Met QC Criteria

March 15, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000589544
  • -MANTEAU-2010-SA (Other Identifier: FILO)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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