B-cells CLL Chronic Lymphocytic Leukaemia MedDRA version: 9.1 Level: SOC Classification code 10029104 Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: MABCAMPATH*EV 3F 3ML 10MG/ML
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Alemtuzumab
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number
Sponsors
AZIENDA OSPEDALIERA OSPEDALE NIGUARDA CA' GRANDA (A.O. DI RILIEVO NAZIONALE)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: signed informed consent male or female > 17 years WHO performance status 0-II life expectancy at least 6 months confirmation of LLC-B 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: No previous chemotherapy or immunotherapy Previous CAMPATH 1H admistered in combination with chemotherapy HIV HBV HCV positive
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the activity of the combination oral fludarabine, os cyclophosphamide and s.c. CAMPATH 1H in inducing CR or PR;Secondary Objective: response duration time to progression safety and tolerability profile to evaluate in vivo purging effect of FCC by cytofluorometric and molecular analysis to evaluate the pharmacokinetic disappearance rate of CAMPATH 1H when given at this given sc during fludarabine plus cyclophosphamide therapy;Primary end point(s): Efficacy will be assessed by overall response rate comprising complete remission and partial response defined by NCI | — |
Countries
Italy
Outcome results
None listed