EUCTR2008-006491-30-FRActive, not recruitingNot Applicable
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-entretien
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Centre Henri Becquerel
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •-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
- •-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
Investigators
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