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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00261612 |
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Date of registration:
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01/12/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Bortezomib, Rituximab and Dexamethasone (BORID) for Relapsed/Refractory Mantle Cell Lymphoma
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Scientific title:
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Date of first enrolment:
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January 2005 |
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Target sample size:
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16 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00261612 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Austria
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Contacts
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Name:
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Johannes Drach, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Medical University Vienna |
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Key inclusion & exclusion 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
Age minimum:
19 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Lymphoma, Mantle-Cell
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Intervention(s)
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Drug: bortezomib
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Drug: rituximab
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Drug: dexamethasone
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Procedure: treatment protocol
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Primary Outcome(s)
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response rate
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Secondary Outcome(s)
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progression free survival
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overall survival
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safety
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Secondary ID(s)
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2004-002150-64
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MCL 03
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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