patients whit LLC MedDRA version: 9.1 Level: LLT Classification code 10008958 Term: Chronic lymphocytic leukaemia
Conditions
Interventions
Trade Name: ribomustine
Pharmaceutical Form: Powder and solvent for solution for infusion
INN or Proposed INN: Bendamustine
Concentration unit: mg/m2 milligram(s)/square meter
Concentration type: equa
Sponsors
Associazione Malattie Sangue Onlus
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -age 18 years or older - WHO status 0-II - life expectancy > 6 monts - relapsed or refractory patients after treatment including alkylatin agents or purine analogs or monoclonal antobodies (Rituximab) - correct renal and liver function 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - mo concomitant treatment with chemotherapy or immunotherapy - previous Alemtuzumab administered - negativity for the CD52+ marker - HIV positivity
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine best tolarable combination regimen of Bendamustine and Alemtuzumab assessed by determining dose limiting toxiciti and maximum tolerated dose;Secondary Objective: -to determine: - de in vivo affect of the combination by flowcytometric evaluation and molecular analysis for mutations in the IgVH genes in bone marrow lymphocites -pharmacocainetic profile of combination -prolong duration of progression free survival;Primary end point(s): To determine best tolarable combination regimen of Bendamustine and Alemtuzumab assessed by determining dose limiting toxiciti and maximum tolerated dose | — |
Countries
Italy
Outcome results
None listed