Etude prospective, multicentrique, de phase II testant la faisabilité d’un traitement d’entretien par l’alemtuzumab chez des patients porteurs de leucémie lymphoïde chronique, traités et répondant à l’alemtuzumab - Campath-LLC-entretie
- Conditions
- Chronic lymphoid leukemia in complete remission (CR) or partial remission (PR)
- Registration Number
- EUCTR2008-006491-30-FR
- Lead Sponsor
- Centre Henri Becquerel
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
-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
-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 <60 ml / min calculated using the formula of Cockcroft and Gault
- Total bilirubin, gamma-glutamyltransferase rate transaminase> 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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, <br>• Duration of response (CR, PR, phenotypic response) <br>• Conversion rates PR-CR, clinical and phenotypic <br>• rate of side effects related to treatment <br>• Incidence and intensity of infectious events. <br>• Monitoring of residual disease (MRD) studied by phenotypic analysis by 4 colors flow cytometry
- Secondary Outcome Measures
Name Time Method