A Phase 1/2 interventional study of SPC2996 in Chronic Lymphocytic Leukemia, sponsored by Santaris Pharma A/S. Completed at 12 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-02-02.
Sponsored by Santaris Pharma A/S · Phase 1/2, Interventional, and Treatment
The purpose of this study is to determine whether SPC2996 is effective and safe in the treatment of Chronic Lymphocytic Leukaemia (CLL)
Chronic Lymphocytic Leukaemia (CLL) is the most common leukaemia in adults in the US and most of Western Europe. Many patients suffering from CLL have tumour cells expressing high amounts of Bcl-2 protein. Since over expression of Bcl-2 inhibits apoptosis, it is possible that this gene participates in the pathogenesis of CLL. By lowering the Bcl-2 protein in these tumour cells the cells may go into apoptosis due to changed balance in pro- and anti apoptotic proteins and thereby it might be possible to induce a tumour response.
The study is an open-labelled, international, multicenter, dose escalating phase I/II study where patients receive 6, 3, 2 or 1 dose(s) of SPC2996, a LNA antisense molecule against Bcl-2, over a period of up to 2 weeks, and are followed for 6 months.
5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.
This study's planned enrollment of 46 is above the median of 38 across 4,247 interventional studies indexed under Leukemia.
Browse Leukemia studies →Santaris Pharma A/S is the lead sponsor of 9 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Change in Bcl-2 m-RNA levels
Time frame: from Day 0 to Day 13
Change in Bcl-2 protein expression. Change in Bcl-2 m-RNA levels (and other parameters)
Time frame: from Day 0 to Day 14 and during study respectively
This study is completed, as verified in Feb 2011. You cannot join it, but the record below documents what was studied.
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Santaris Pharma A/S