Bortezomib, Rituximab and Dexamethasone (BORID) for Relapsed/Refractory Mantle Cell Lymphoma
This trial is active, not recruiting.
|Treatments||bortezomib, rituximab, dexamethasone, treatment protocol|
|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|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
progression free survival
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
|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)|
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