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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00740415
First Posted: August 25, 2008
Last Update Posted: March 16, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Janssen, LP
Mundipharma Pte Ltd.
Information provided by (Responsible Party):
French Innovative Leukemia Organisation
  Purpose

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
Lymphoma Biological: rituximab Drug: bortezomib Drug: dexamethasone Drug: Bendamustine Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (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 ]

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:

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   65 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00740415


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

Additional Information:
Responsible Party: French Innovative Leukemia Organisation
ClinicalTrials.gov Identifier: NCT00740415     History of Changes
Other Study ID Numbers: CDR0000589544
-MANTEAU-2010-SA ( Other Identifier: FILO )
First Submitted: August 22, 2008
First Posted: August 25, 2008
Last Update Posted: March 16, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
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
Lymphoma, Mantle-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Dexamethasone acetate
Dexamethasone
Rituximab
Bortezomib
Bendamustine Hydrochloride
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunologic Factors