Chronic Lymphocytic Leukemia Clinical Trial
Official title:
An 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
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.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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