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

This study has been completed.
Janssen, LP
Mundipharma Pte Ltd.
Information provided by (Responsible Party):
French Innovative Leukemia Organisation Identifier:
First received: August 22, 2008
Last updated: March 15, 2016
Last verified: March 2016

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.

Condition Intervention Phase
Biological: rituximab
Drug: bortezomib
Drug: dexamethasone
Drug: Bendamustine
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by French Innovative Leukemia Organisation:

Primary Outcome Measures:
  • Overall response rate after 4 courses of therapy [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]

Enrollment: 39
Study Start Date: June 2007
Study Completion Date: August 2015
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Mabthera ®,
Drug: bortezomib
-Velcade®, 1,3 mg/m2 Intraveinous on days 1, 4, 8 and 11
Other Name: Velcade
Drug: dexamethasone
day - Dexamethasone, 40 mg Intraveinous
Drug: Bendamustine
-Day 1 and day 2 Bendamustine/Levact ®,, 90 mg/m2 Intraveinous
Other Name: Levact ®

Detailed Description:



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


  • 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.


Ages Eligible for Study:   65 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No


  • Diagnosis of mantle cell lymphoma

    • Stage II-IV disease
  • No neuromeningeal disease


  • 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


  • Not specified
  Contacts and Locations
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Please refer to this study by its identifier: NCT00740415

CHU de Grenoble - Hopital Michallon
Grenoble, France, 38043
Sponsors and Collaborators
French Innovative Leukemia Organisation
Janssen, LP
Mundipharma Pte Ltd.
Study Chair: Remy Gressin, MD CHU de Grenoble - Hopital de la Tronche
  More Information

Additional Information:
Responsible Party: French Innovative Leukemia Organisation Identifier: NCT00740415     History of Changes
Other Study ID Numbers: CDR0000589544  -MANTEAU-2010-SA 
Study First Received: August 22, 2008
Last Updated: March 15, 2016
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by French Innovative Leukemia Organisation:
contiguous stage II mantle cell lymphoma
noncontiguous stage II mantle cell lymphoma
stage III mantle cell lymphoma
stage IV mantle cell lymphoma

Additional relevant MeSH terms:
Lymphoma, Mantle-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Dexamethasone acetate
Dexamethasone 21-phosphate
Bendamustine Hydrochloride
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on October 21, 2016