A Study of Dasatinib in Chronic Lymphocytic Leukemia in Patients Who Exhibit in Vitro Dasatinib Sensitivity
The purpose of this study is to estimate the biologic target activity of dasatinib in Chronic lymphocytic leukemia (CLL) patients found to have pre-treatment in vitro dasatinib cytotoxicity (as defined by a ≥50% decrease in absolute lymphocyte, count, and/or bone marrow CLL cells, lymph node or spleen size).
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Dasatinib in Chronic Lymphocytic Leukemia in Patients Who Exhibit in Vitro Dasatinib Sensitivity|
- 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). [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: No ]
- In vitro cytotoxicity = in vitro dasatinib sensitivity (IC50) of ≤50 nanomolar (nM) as determined in primary CLL cells via MTS assay.
- Clinical activity =as defined by a ≥50% decrease in absolute lymphocyte, count, and/or bone marrow CLL cells, lymph node or spleen size
- Drug safety and tolerability of dasatinib in patients with CLL by assessing the number of participants with adverse events as a measure of safety and tolerability [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: Yes ]
- Overall Survival(OS) [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: No ]
- Progression-free survival (PFS) [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||October 2011|
|Estimated Study Completion Date:||July 2015|
|Estimated Primary Completion Date:||November 2014 (Final data collection date for primary outcome measure)|
Dasatinib will be administered at a starting dose of 140 mg by mouth once daily. Tablets come in 50 mg and 20 mg. Thus, 4 tablets will be taken once daily (20mg + 20mg + 50 mg + 50 mg) for a total of 140 mg daily. Dasatinib should be taken around the same time each day.
Other Name: Sprycel
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01441882
|Contact: Jocelyn Adamo||503-418-2086||Digregor@ohsu.edu|
|United States, Oregon|
|OHSU Knight Cancer Institute||Recruiting|
|Portland, Oregon, United States, 97239|
|Contact: Stephen Spurgeon, M.D. 503-494-1551 Spurgeos@ohsu.edu|
|Principal Investigator: Stephen Spurgeon|
|Principal Investigator:||Stephen Spurgeon, M.D.||OHSU Knight Cancer Institute|