A Phase II Study of Dasatinib in Chronic Lymphocytic Leukemia in Patients Who Exhibit in Vitro Dasatinib Sensitivity
Chronic lymphocytic leukemia (CLL) is the most common leukemia in the Western World with
10,000 new cases per year in the United States and an estimated 4,500 deaths annually.
Currently, therapy seeks to calm symptoms and improve fevers. While many patients have
non-aggressive disease, requiring no or only irregular treatment, a large number of
patient's disease progresses rapidly, does not respond to treatment, and as a result,
patients die from their disease. A number of factors have been identified that help predict
poor outcomes including stage, genetic factors, and certain protein expression. However, the
investigators have little means available to determine which patients may benefit from
targeted treatment. Efforts have focused on blocking a certain protein family, which
recently showed promising results in CLL. Given dasatinib's (now referred to as the study
drug) ability to target those certain proteins, the investigators have examined the effects
of the study drug in primary CLL cells in a test tube and have gathered promising data
illustrating the effect of the study drug on cancer cells. Therefore, the investigators will
be conducting a clinical trial using the study drug in patients with relapsed/refractory or
poor risk CLL.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Biologic target activity of dasatinib in CLL patients found to have pre-treatment in vitro dasatinib cytotoxicity (as defined by a ≥50% decrease in absolute lymphocyte count and/or lymph node size).
In vitro cytotoxicity = in vitro dasatinib sensitivity (IC50) of ≤10 nM as determined in primary CLL cells via MTS assay. Clinical activity = a decrease in absolute lymphocyte count (ALC) in the peripheral blood or bone marrow or measurable lymph nodes by 50%.
Up to 24 weeks
Stephen Spurgeon, M.D.
OHSU Knight Cancer Institute
United States: Food and Drug Administration
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