Dasatinib in Relapsed Chronic Lymphocytic Leukemia
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Dasatinib (BMS-354825) in Relapsed Chronic Lymphocytic Leukemia|
- 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). [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- The Complete Response Rate Will Also be Evaluated [ Time Frame: TBD ] [ Designated as safety issue: No ]
- Duration of Overall Response for All Patients [ Time Frame: TBD ] [ Designated as safety issue: No ]
- to Determine the Progression-free Survival and Overall Survival [ Time Frame: TBD ] [ Designated as safety issue: No ]
- to Define the Spectrum of Toxicities of This Treatment in This Patient Population [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- and to Correlate LYN Kinase Activity With Response in Study Subjects. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
|Study Start Date:||December 2006|
|Study Completion Date:||March 2013|
|Primary Completion Date:||October 2010 (Final data collection date for primary outcome measure)|
Experimental: Dasatinib treatment
All patients were treated with dasatinib pills by mouth as treatment.
Taken orally once daily. Participants may continue on study treatment as long as there is no disease progression or serious side effects.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00438854
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Philip Amrein, MD||Massachusetts General Hospital|