Bortezomib, Rituximab and Dexamethasone (BORID) for Relapsed/Refractory Mantle Cell Lymphoma

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. Identifier: NCT00261612
Recruitment Status : Unknown
Verified October 2006 by Medical University of Vienna.
Recruitment status was:  Active, not recruiting
First Posted : December 5, 2005
Last Update Posted : October 18, 2006
Information provided by:
Medical University of Vienna

Brief Summary:
Mantle cell lymphoma (MCL) remains difficult to treat by standard treatment approaches. Novel drugs have shown promising results in early clinical evaluations. In the current trial, we investigate a combination of bortezomib (a proteasome inhibitor), rituximab (a monoclonal antibody), and dexamethasone in patients with MCL, who have already been pretreated by standard chemotherapy and show again signs of disease progression. The study objectives include remission rates, safety of this drug combination, and survival time.

Condition or disease Intervention/treatment Phase
Lymphoma, Mantle-Cell Drug: bortezomib Drug: rituximab Drug: dexamethasone Procedure: treatment protocol Phase 2

Detailed Description:
Description of the treatment regimen: Bortezomib: 1.3 mg/m2 as i.v. bolus injection, given on days 1, 4, 8, and 11 of each treatment cycle; Rituximab: 375 mg/m2 infusion, day 1 of each cycle; Dexamethasone: 40 mg per day orally (days 1 – 4) of each treatment cycle. Treatment will be given for a total of 6 cycles (every 21 days), followed by maintenance treatment with rituximab (375 mg/m2 every two months for 4 times)

Study Type : Interventional  (Clinical Trial)
Enrollment : 16 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : January 2005
Study Completion Date : January 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
U.S. FDA Resources

Primary Outcome Measures :
  1. response rate

Secondary Outcome Measures :
  1. safety
  2. progression free survival
  3. overall survival

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • mantle cell lymphoma at stage II - IV, previously treated with at least one line of prior therapy (CHOP or CHOP-like), measurable disease, age 19 - 75 years, adequate cardiac, liver and renal function tests, patient's written informed consent

Exclusion Criteria:

  • second malignancy, evidence for CNS involvement, clinically significant peripheral neuropathy (grade II or higher), HIV positivity, pregnancy

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 identifier (NCT number): NCT00261612

Medical University Vienna, Dept. of Medicine I, Clinical Division of Oncology
Vienna, Austria
Sponsors and Collaborators
Medical University of Vienna
Principal Investigator: Johannes Drach, MD Medical University Vienna

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00261612     History of Changes
Other Study ID Numbers: 2004-002150-64
MCL 03
First Posted: December 5, 2005    Key Record Dates
Last Update Posted: October 18, 2006
Last Verified: October 2006

Keywords provided by Medical University of Vienna:
relapsed or chemotherapy-refractory disease

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
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
Immunologic Factors
Antirheumatic Agents