SPC2996 in Chronic Lymphocytic LeukaemiaAn open-labelled, international multicenter dose escalating, phase I/II study of SPC2996, an LNA antisense molecule against Bcl-2, in patients with relapsed or refractory Chronic Lymphocytic Leukaemia - SPC2996 in Chronic Lymphocytic Leukaemia
- Conditions
- 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.
- Registration Number
- EUCTR2004-004741-17-DK
- Lead Sponsor
- Santaris Pharma
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 42
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
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)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method