Overview

This trial is active, not recruiting.

Condition lymphoma, mantle-cell
Treatments bortezomib, rituximab, dexamethasone, treatment protocol
Phase phase 2
Targets CD20, proteasome
Sponsor Medical University of Vienna
Start date January 2005
End date January 2007
Trial size 16 participants
Trial identifier NCT00261612, 2004-002150-64, MCL 03

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Measure
response rate
time frame:

Secondary Outcomes

Measure
safety
time frame:
progression free survival
time frame:
overall survival
time frame:

Eligibility Criteria

Male or female participants from 19 years up to 75 years old.

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

Additional Information

Principal investigator Johannes Drach, MD
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)
Trial information was received from ClinicalTrials.gov and was last updated in October 2006.
Information provided to ClinicalTrials.gov by Medical University of Vienna.