Rituximab and Campath are two antibodies directed against CD20 and CD52 antigen, respectively. The highest response rate in the B-CLL treatment has been obtained by the association of Fludarabine, Cyclophosphamide and Rituximab. The association of Fludarabine and Campath has also shown high response rate . This study will then compare Campath with Rituximab in association with Fludarabine-Cyclophosphamide. MedDRA version: 9.1 Level: LLT Classification code 10009310 Term: CLL
Conditions
Interventions
Trade Name: IMP1 : MabCampath (Alemtuzumab)
Product Name: MabCampath
Pharmaceutical Form: Injection*
INN or Proposed INN: Alemtuzumab
Concentration unit: mg/ml milligram(s)/millilitre
Concentration ty
Sponsors
GOELAMS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: * B-CLL * Age > 18 years * Del 17 p (FISH) negative (=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: * A BINET stage * Del 17 p (FISH) positive ( > 10 % positives cores) * Age 6 (see Appendix for calculation of CIRS score) * Concomitant disease requiring prolonged use of corticosteroids (> 1 month) * Known hypersensitivity with anaphylactic reaction to humanized monoclonal antibodies or any of the study drugs * Contraindication to the use of Mabthera® or MabCampath® according to SmPC. * Transformation to aggressive B-cell malignancy (e.g. diffuse large cell lymphoma, Hodgkin lymphoma, or prolymphocytic leukaemia) * Active bacterial, viral or fungal infection * Abnormal renal function with creatinine clearance 2 ULN. * Any coexisting medical or psychological condition that would preclude participation in the required study procedures * Patient with mental deficiency preventing proper understanding of the requirements of treatment. * Pregnant or breastfeeding women. * Fertile male and female patients who cannot or do not wish to use an effective method of contraception, during and for 12 months after the final treatment used for the purposes of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: progression-free survival (PFS) at 36 month;Secondary Objective: * Disease-free survival, event-free survival, overall survival, time to next treatment * ORR (CR and PR) according to NCI, rates of phenotypic and molecular responses * Duration of phenotypic, molecular, NCI CR and PR responses * Response rates and survival times in biological subgroups * Rates of treatment-related adverse effects * Minimal residual disease (MRD) study * Quality of life ;Primary end point(s): The objective of this study is to compare, on progression-free survival (PFS) at 36 months, FCR and FCCam in first-line therapy of B and C Binet stage B-CLL patients. | — |
Countries
Belgium, France
Outcome results
None listed