The purpose of this research study is to see if Dasatinib is effective and safe to give to people with relapsed chronic lymphocytic leukemia (CLL) and to determine the effects of the drug on LYN kinase activity in blood and bone marrow. Recent research shows that a key enzyme in CLL cells is responsible for cell survival. This enzyme is called LYN kinase. Laboratory studies show that inhibition of LYN kinase in CLL cells results in the death to CLL cells. Dasatinib has the ability to inhibit LYN kinase and, therefore, should have some effect on CLL cells.
* After the screening procedures confirm that the participant is eligible and willing to participate in the research study, they will have the following tests and procedures. * Dasatinib is given orally once daily. Each participant will have a pill diary to record doses and any missed doses. All necessary drug refills will be given during clinic appointments, at which time the pill diary and any unused study drug will be returned. * During the first month of study treatment the participant will come to the clinic at the following intervals: Day 1: An EKG will be performed two hours after the first dose of medication; Days 3-8: Blood samples will be drawn once between days 3-8; Weeks 2-4: A physical examination, EKG and blood samples will be drawn once a week. * Beginning with the second month of study treatment, participants will come to the clinic monthly for up to two years. The following tests and procedures will be done; physical examination (monthly), blood work (monthly), pregnancy test (monthly), EKG (monthly for 6 months, then when medically indicated), CT of the neck, chest and abdomen (every 2 months for 6 months, then once every 6 months), at the end of month 2, additional blood will be drawn for research testing. * Participants can continue to take the study drug for up to two years as long as their disease does not progress and they are not experiencing any serious side effects.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Taken orally once daily. Participants may continue on study treatment as long as there is no disease progression or serious side effects.
Massachusetts General Hospital
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Overall Objective Response
Overall objective response rate in terms of complete response, nodular partial response, and partial response to treatment. Objective response is when a biopsy shows. In general response is defined as the following (not complete criteria): Complete response (CR) requires all of the following for a period of at least 2 months: * Absence of lymphadenopathy * No hepatomegaly or splenomegaly * Absence of constitutional symptoms * Normal complete blood count Nodular partial response (nPR): Met the criteria for CR, but had residual bone marrow biopsy nodules as the only evidence of disease Partial response (PR): requires at least the following: * 50% decrease in peripheral blood lymphocyte count * 50% reduction in lymphadenopathy * 50% reduction in the size of the liver and/or spleen
Time frame: 2 years
Complete Response Rate
The number of participants with a 100% reduction in nodal mass.
Time frame: 1 year
Median Time to Disease Progression
The median time to disease progression, measured from the start of treatment.
Time frame: 1 year
Median Overall Survival
The median survival time, as measured from the start of treatment until death from any cause.
Time frame: 3 years
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Enrollment
15