Clinical trial NCT00261612: Bortezomib, Rituximab and Dexamethasone (BORID) for Relapsed/Refractory Mantle Cell Lymphoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Lymphoma, Mantle-Cell
Keywords: relapsed or chemotherapy-refractory disease
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2005-12-05
Enrollment: 16
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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)

Eligibility 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

Primary outcomes:
measure: response rate
Secondary outcomes:
measure: safety
measure: progression free survival
measure: overall survival
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University Vienna, Dept. of Medicine I, Clinical Division of Oncology
Study officials:
affiliation: Medical University Vienna
name: Johannes Drach, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Drach J, Seidl S, Kaufmann H. Treatment of mantle cell lymphoma: targeting the microenvironment. Expert Rev Anticancer Ther. 2005 Jun;5(3):477-85. doi: 10.1586/14737140.5.3.477.
citation: Kaufmann H, Raderer M, Wohrer S, Puspok A, Bankier A, Zielinski C, Chott A, Drach J. Antitumor activity of rituximab plus thalidomide in patients with relapsed/refractory mantle cell lymphoma. Blood. 2004 Oct 15;104(8):2269-71. doi: 10.1182/blood-2004-03-1091. Epub 2004 May 27.
citation: Lamm W, Kaufmann H, Raderer M, Hoffmann M, Chott A, Zielinski C, Drach J. Bortezomib combined with rituximab and dexamethasone is an active regimen for patients with relapsed and chemotherapy-refractory mantle cell lymphoma. Haematologica. 2011 Jul;96(7):1008-14. doi: 10.3324/haematol.2011.041392. Epub 2011 Apr 12.