Overview

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

Status:
Unknown status

Trial end date:
2007-01-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Medical University of Vienna

Treatments:

BB 1101
Bortezomib
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Rituximab

Criteria

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