E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chronic Lymphocytic Leukaemia (CLL) is the most common leukaemia in adults in the US and most of Western Europe. The incidence is 8100 to 12500 new cases in the US per year. CLL is a relatively indolent disease mainly of the elderly. CLL is a disease of B cell origin grouped together with small lymphocytic lymphoma (SLL) in the WHO classification system. CLL and SLL together correspond to around 20 % of all NHL cases. |
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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 |
To investigate the safety and efficacy of SPC2996 in CLL patients
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E.2.2 | Secondary objectives of the trial |
To find the Maximum Tolerated Dose, the Biologic Active Dose and determine the pharmacokinetics after a single dose and after multiple doses of SPC2996 in patients with Chronic Lymphocytic Leukaemia |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1) Relapsed or refractory CLL/SLLrequiring therapy 2) Circulating lymphocytes > 5 x 109/L at screening blood sample 3) Circulating lymphocytes expressing the following phenotype at screening blood sample: CD5+CD20+CD23+ 4) (This inclusion criterion has been deleted according to Intl. Protocol Amendment 2, dated 25 January 2006) 5) Age ≥ 18 years 6) Following receipt of oral and written information about the study the patient must give a signed consent before any study related activity is carried out.
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E.4 | Principal exclusion criteria |
1) Previous treatment with rituximab within 6 months prior to Visit 1 2) Previous treatment with alemtuzumab within 6 months prior to Visit 1 3) Previous autologous stem cell transplantation within 6 months prior to Visit 1 4) Previous allogeneic stem cell transplantation 5) Received any of the following treatments within 4 weeks prior to Visit 1: • Anti-cancer therapy • Glucocorticoids unless ≤ 10 mg prednisolon /day for other indications than CLL • Radiotherapy 6) Known or suspected transformation of CLL (e.g. B-symptoms, fast growing tumour or increasing LDH level)
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E.5 End points |
E.5.1 | Primary end point(s) |
Change in Bcl-2 protein expression from Day 0 to Day 13 |
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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 | Yes |
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 | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
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 | No |
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 | No |
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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
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.8.5 | The trial involves multiple Member States | Yes |
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 | Information not present in EudraCT |
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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End of trial is last patient last visit. |
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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 | 3 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 3 |