19 Years
75 Years
Both
Lymphoma, Mantle-Cell
Trial Information
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)
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
response rate
Principal Investigator
Johannes Drach, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Medical University Vienna
Authority:
Austria: Federal Ministry for Health and Women
Study ID:
2004-002150-64
NCT ID:
NCT00261612
Start Date:
January 2005
Completion Date:
January 2007
Related Keywords:
- Lymphoma, Mantle-cell
- relapsed or chemotherapy-refractory disease
- Lymphoma
- Lymphoma, Mantle-Cell
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