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

Sponsor

Medical University of Vienna (Other)

Overall Status

Unknown status

CT.gov ID

NCT00261612

Collaborator

(none)

Enrollment

Location

Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Lymphoma, Mantle-Cell	Drug: bortezomib Drug: rituximab Drug: dexamethasone Procedure: treatment protocol	Phase 2

Detailed 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)

Study Design

Study Type:

Interventional

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Study Start Date :

Jan 1, 2005

Study Completion Date :

Jan 1, 2007

Outcome Measures

Primary Outcome Measures

response rate []

Secondary Outcome Measures

safety []
progression free survival []
overall survival []

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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