Phase II Study of Dasatinib (BMS-354825) in Relapsed Chronic Lymphocytic Leukemia
- 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
- 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.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall Objective Response Rate in Terms of Complete Response, Nodular Partial Response, and Partial Response to Treatment With Dasatinib for Patients With CLL/SLL (Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma).
Philip Amrein, MD
Massachusetts General Hospital
United States: Institutional Review Board
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|