WALDENSTROM?S MACROGLOBULINEMIA OR SMALL LYMPHOCYTIC LYMPHOMA MedDRA version: 9.1 Level: LLT Classification code 10003908 Term: B-cell small lymphocytic lymphoma
Conditions
Interventions
Trade Name: LEUKERAN*25CPR RIV 2MG
Pharmaceutical Form: Tablet
INN or Proposed INN: Chlorambucil
CAS Number: 305-03-3
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number
Sponsors
ISTITUTO EUROPEO DI ONCOLOGIA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? Age >= 18 years and 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
Exclusion criteria
Exclusion criteria: ? History of clinically relevant liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurological, rheumatologic, haematological,....
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to assess the antitumor activity of bortezomib ? chlorambucil association in terms of response rate (ORR) i.e. sum of complete and partial response;Secondary Objective: Safety, as acute and long-term toxicity Response duration (RD) (time to relapse or progression) in responders Progression-free survival (PFS) (time to disease progression or death from disease) in all patients. ? Quality of life with questionary FACT/GOG (Appendix VII) Biological evaluation;Primary end point(s): response rate (ORR) i.e. sum of complete and partial response | — |
Countries
Italy
Outcome results
None listed