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.
Conditions
Interventions
Product Name: SPC2996
Product Code: SPC2996
Pharmaceutical Form: Powder for infusion*
Current Sponsor code: SPC2996
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentr
Sponsors
Santaris Pharma
Eligibility
Sex/Gender
All
Inclusion criteria
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. 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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the safety and efficacy of SPC2996 in CLL patients ;Secondary Objective: 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;Primary end point(s): Change in Bcl-2 protein expression from Day 0 to Day 13 | — |
Countries
Denmark, United Kingdom
Outcome results
None listed