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

NCT ID: NCT00261612

Last Updated: 2006-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2007-01-31

Brief Summary

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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.

Detailed Description

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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)

Conditions

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Lymphoma, Mantle-Cell

Keywords

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relapsed or chemotherapy-refractory disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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bortezomib

Intervention Type DRUG

rituximab

Intervention Type DRUG

dexamethasone

Intervention Type DRUG

treatment protocol

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Principal Investigators

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Johannes Drach, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University Vienna

Locations

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Medical University Vienna, Dept. of Medicine I, Clinical Division of Oncology

Vienna, , Austria

Site Status

Countries

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Austria

References

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Drach J, Seidl S, Kaufmann H. Treatment of mantle cell lymphoma: targeting the microenvironment. Expert Rev Anticancer Ther. 2005 Jun;5(3):477-85. doi: 10.1586/14737140.5.3.477.

Reference Type BACKGROUND
PMID: 16001955 (View on PubMed)

Kaufmann H, Raderer M, Wohrer S, Puspok A, Bankier A, Zielinski C, Chott A, Drach J. Antitumor activity of rituximab plus thalidomide in patients with relapsed/refractory mantle cell lymphoma. Blood. 2004 Oct 15;104(8):2269-71. doi: 10.1182/blood-2004-03-1091. Epub 2004 May 27.

Reference Type BACKGROUND
PMID: 15166030 (View on PubMed)

Lamm W, Kaufmann H, Raderer M, Hoffmann M, Chott A, Zielinski C, Drach J. Bortezomib combined with rituximab and dexamethasone is an active regimen for patients with relapsed and chemotherapy-refractory mantle cell lymphoma. Haematologica. 2011 Jul;96(7):1008-14. doi: 10.3324/haematol.2011.041392. Epub 2011 Apr 12.

Reference Type DERIVED
PMID: 21486866 (View on PubMed)

Other Identifiers

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MCL 03

Identifier Type: -

Identifier Source: secondary_id

2004-002150-64

Identifier Type: -

Identifier Source: org_study_id