Bortezomib maintenance therapy in newly diagnosed patients with mantle cell lymphoma, responsive on rituximab combined with CHOP and high dose Ara-C and after BEAM with auto PSCT rescue.
Recruiting
- Conditions
- MCL (WHO classification)Ann Arbor stage II ¨C IV CD20 positive
- Registration Number
- NL-OMON24708
- Lead Sponsor
- Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON) P/a HOVON Data CenterErasmus MC - Daniel den HoedPostbus 52013008 AE RotterdamTel: 010 7041560Fax: 010 7041028e-mail: hdc@erasmusmc.nl
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 90
Inclusion Criteria
1. Patients with histologically and immunologically proven diagnosis of MCL (WHO classification);
2. Ann Arbor stage II ¨C IV;
Exclusion Criteria
1. Renal failure (creatinine clearance < 50 ml/min);
2. Known hypersensitivity to murine antibodies, boron or mannitol;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Event free survival (EFS).
- Secondary Outcome Measures
Name Time Method 1. Residual disease (quality of remission) as measured with FDG-PET, flow cytometry and molecular studies;<br /><br>2. Toxicity of bortezomib maintenance therapy after high dose treatment;<br /><br>3. Overall survival.