Dasatinib in Relapsed Chronic Lymphocytic Leukemia
|ClinicalTrials.gov Identifier: NCT00438854|
Recruitment Status : Completed
First Posted : February 22, 2007
Results First Posted : October 12, 2012
Last Update Posted : December 13, 2017
|Condition or disease||Intervention/treatment||Phase|
|Chronic Lymphocytic Leukemia||Drug: Dasatinib||Phase 2|
- 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 (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Dasatinib (BMS-354825) in Relapsed Chronic Lymphocytic Leukemia|
|Study Start Date :||December 2006|
|Actual Primary Completion Date :||October 2010|
|Actual Study Completion Date :||March 2013|
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.
- Overall Objective Response [ Time Frame: 2 years ]
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
- Complete Response Rate [ Time Frame: 1 year ]The number of participants with a 100% reduction in nodal mass.
- Median Time to Disease Progression [ Time Frame: 1 year ]The median time to disease progression, measured from the start of treatment.
- Median Overall Survival [ Time Frame: 3 years ]The median survival time, as measured from the start of treatment until death from any cause.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|