E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
B-Chronic Lymphocytic Leukemia |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 11 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10008960 |
E.1.2 | Term | <Manually entered code. Term in E.1.1> |
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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 |
The main objective is to assess the safety of LFB-R603 administered to patients suffering from advanced B-CLL, relapsed or refractory after at least one prior course of fludarabin. |
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E.2.2 | Secondary objectives of the trial |
The secondary objectives are :
For phase I, to select the recommended dose regimen for phase II
For phase I and II : - to assess the pharmacokinetic parameters of LFB-R603 - to assess the immunogenicity of LFB-R603 - to assess the efficacy of LFB-R603 based on laboratory, clinical and radiological exams - to present a descriptive statistics of vital signs and laboratory values
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Signed and dated informed consent 2. Relapsed or refractory B-CLL after at least one prior course of therapy with Fludarabine (F) 3 .Circulating lymphocytes expressing CD20, CD5, CD19 and CD23 membrane proteins 4 .18 years ≤ age ≤ 80 years, both genders 5. Peripheral blood lymphocyte count > 5.10exp9/l 6. ECOG performance status ≤ 2 7. Life expectancy ≥ 3 months
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E.4 | Principal exclusion criteria |
1. Transformation of CLL into a high grade lymphoma 2. Allogeneic stem-cell transplantation < 6 months before enrolment 3. Prior treatment with rituximab and/or ofatumumab < 6 months before enrolment 4. Prior treatment with alemtuzumab < 2 months before enrolment 5. Known severe anaphylactic or other hypersensitivity reactions secondary to a previous exposure to murine antibodies or to any component of LFB-R603 6. Patient with a concomitant malignancy other than basal cell carcinoma of the skin, or in situ carcinoma of the cervix or the breast 7. Patient with serious non-malignant disease, severe / unstable HTA, active infection requiring sytemic antibiotic, antifungal or anti viral drug or physical examination or laboratory abnormalities, that, in the opinion of the Investigator, would compromise protocol objectives 8. Creatinine clearance, calculated according to Cockroft-Gault formula, < 60 mL/min 9. AST and/or ALT level > 1,5 times the upper limit of normal 10. Pregnancy or breastfeeding
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E.5 End points |
E.5.1 | Primary end point(s) |
Safety evaluated by Adverse event(s) is the primary end-point of the study. Adverse events will be reported throughout the study period using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | Yes |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Yes |
E.7.1.1 | First administration to humans | Yes |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | Yes |
E.7.1.3.1 | Other trial type description |
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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 | 7 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 16 |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |