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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2006 by Medical University of Vienna.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT00261612
First received: December 1, 2005
Last updated: October 17, 2006
Last verified: October 2006
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • response rate

Secondary Outcome Measures:
  • safety
  • progression free survival
  • overall survival

Estimated Enrollment: 16
Study Start Date: January 2005
Estimated Study Completion Date: January 2007
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)

  Eligibility

Ages Eligible for Study:   19 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00261612

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

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00261612     History of Changes
Other Study ID Numbers: 2004-002150-64, MCL 03
Study First Received: December 1, 2005
Last Updated: October 17, 2006
Health Authority: Austria: Federal Ministry for Health and Women

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

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
Dexamethasone 21-phosphate
Rituximab
Bortezomib
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors

ClinicalTrials.gov processed this record on April 22, 2014