Bortezomib, Rituximab, and Dexamethasone (BORID), followed by Rituximab maintenance, for patients with relapsed/refractory mantle cell lymphoma - BORID in relapsed mantle cell lymphoma

• Conditions: relapsed mantle cell lymphoma

• Registration Number: EUCTR2004-002150-64-AT
• Lead Sponsor: Medical University Vienna, Dept. of Medicine I, Clinical Division of Oncology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2004-11-17
• Last Update Posted: 27 January 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

·Patients with histologically confirmed diagnosis of CD20-positive mantle cell lymphoma, who were previously treated with at least one line of standard therapy (CHOP or CHOP-like chemotherapy)·
Ann Arbor Stage II-IV·
Age 19 – 75 years·
ECOG performance status of 0,1 or 2.·
Measurable disease·
Adequate cardiac, renal and liver function tests.·
Absolute neutrophil count (ANC) > 1.0 x 109/L, and platelet count > 50 x 109/L (unless both are attributed directly to bone marrow involvement or auto-immune disease secondary to lymphoma)·
Patient’s written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

·History of malignancy other than squamous cell carcinoma, basal cell carcinoma of the skin or carcinoma in situ of the cervix within the last 5 years.·
Major surgery, other than diagnostic surgery, within the last 4 weeks.·
Evidence of CNS involvement.·
Clinically significant peripheral neuropathy (grade II or greater) ·
A history of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant and adversely affecting compliance to study drugs.·
Clinically significant cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 6 months·
Evidence of any severe active acute or chronic infection.·
HIV-positive, Hbs-antigen positive, or HCV-RNA-positive patients.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Efficacy and safety of Bortezomib (+Rituximab + Dexamethasone) in relapsed/refractory mantle cell lymphoma;Secondary Objective: ;Primary end point(s): Primary objective·<br>to evaluate the activity of BORID with respect to remission induction in patients with previously treated, CD 20 positive mantle cell lymphomaSecondary objectives·To evaluate the safety of BORID in this patient population·<br>to evaluate the activity of BORID on progression free survival (PFS) and overall survival (OS)