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Phase 2
19 Years
75 Years
Open (Enrolling)
Lymphoma, Mantle-Cell

Thank you

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:


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


Austria: Federal Ministry for Health and Women

Study ID:




Start Date:

January 2005

Completion Date:

January 2007

Related Keywords:

  • Lymphoma, Mantle-cell
  • relapsed or chemotherapy-refractory disease
  • Lymphoma
  • Lymphoma, Mantle-Cell