E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chronic lymphoid leukemia in complete remission (CR) or partial remission (PR) |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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 |
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E.2.2 | Secondary objectives of the trial |
•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 |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
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E.4 | Principal 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 |
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E.5 End points |
E.5.1 | Primary end point(s) |
efficacy rate of a maintenance treatment by alemtuzumab: evaluation of clinical and biological status during the 12 months of treatment |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Information not present in EudraCT |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 6 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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1 year after the last visit of the last patient enrolled in the trial |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |