Chronic lymphoid leukemia in complete remission (CR) or partial remission (PR)
Conditions
Interventions
Trade Name: MabCampath
Product Name: MabCampath
Pharmaceutical Form: Concentrate for solution for infusion
Sponsors
Centre Henri Becquerel
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -B-CLL -response (CR or PR) after 12 to 18 weeks alemtuzumab monotherapy -Patient older than 18 years -Whatever the initial Binet stage -Whatever the number of prior courses of therapy for the CLL - Signed Informed Consent 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: -Patients non responder to alemtuzumab (stable or increase) or intolerant - Alemtuzumab in combination (including corticosteroid dose whatever) - Any transformation of the CLL (prolymphocytic leukemia Richter syndrome ) - Adverse central nervous system - Performance Status (ECOG) > 2 - Life expectancy less than 6 months - HIV positive serology - Serology Hepatitis B, C positive (unless vaccination earlier) - Heart failure care III or IV, myocardial infarction in recent months, unstable angina, ventricular arrhythmia during treatment, hypoxemia with COPD, diabetes unbalanced, poorly controlled hypertension - Index of co-morbidity CIRS (Cumulative Illness Rating Scale)> 6 - Known hypersensitivity reaction with anaphylactic humanized monoclonal antibody - Against indication MabCampath ® - Bacterial infections, viral or fungal active - Impaired renal function with creatinine clearance 2 ULN. - Conditions psychological, social, family does not track the study or treatment adherence. - Mental Disability does good understanding of the procedures involved in the test. - Woman pregnant or nursing - Male or female fertility can not use effective contraception during and after 1 year-end processing - Major protected under the law, - A person not affiliated with a social security scheme or beneficiary of such a regime, - Person in a period of exclusion to another study biomedical
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: after induction treatment by MabCampath ® in patients with B CLL, to keep status of complete remission (CR) or partial remission (PR), with the same molecule administered sequentially at 30 mg 15 days for 12 months;Primary end point(s): efficacy rate of a maintenance treatment by alemtuzumab: evaluation of clinical and biological status during the 12 months of treatment;Secondary Objective: •Event-free survival, progression-free survival, overall survival, • Duration of response (CR, PR, phenotypic response) • Conversion rates PR-CR, clinical and phenotypic • rate of side effects related to treatment • Incidence and intensity of infectious events. • Monitoring of residual disease (MRD) studied by phenotypic analysis by 4 colors flow cytometry | — |
Countries
France
Outcome results
None listed