PHASE II TRIAL OF BORTEZOMIB (VELCADE) IN COMBINATION WITH CHLORAMBUCIL IN PATIENTS WITH RELAPSED/REFRACTORY WALDENSTROM?S MACROGLOBULINEMIA OR SMALL LYMPHOCYTIC LYMPHOMA. A MULTICENTER STUDY. - ND
- Conditions
- WALDENSTROM?S MACROGLOBULINEMIA OR SMALL LYMPHOCYTIC LYMPHOMAMedDRA version: 9.1Level: LLTClassification code 10003908Term: B-cell small lymphocytic lymphoma
- Registration Number
- EUCTR2006-003495-35-IT
- Lead Sponsor
- ISTITUTO EUROPEO DI ONCOLOGIA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
?Age >= 18 years and < 70 years
?Histological proven diagnosis of Waldenstrom disease or Small lymphocytic lymphoma by the International Working Formulation (IWF) classification
?Relapsed or refractory disease pre-treated with >1 prior chemotherapy regimen (including monoclonal anti-CD20 as single treatment)
?Symptomatic disease
?Measurable or valuable disease
?Full recovery from previous therapy, with life expectancy of at least 6 months
?ECOG performance status 0-2 (ECOG see Appendix II)
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
?History of clinically relevant liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurological, rheumatologic, haematological,....
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method