Therapy of Chronic Lymphocytic Leukemia With Dasatinib (BMS-354825)
The goal of this clinical research study is to learn if dasatinib can help to control Chronic Lymphocytic Leukemia (CLL). The safety of the drug will also be studied.
Optional Procedures: You will be asked to have additional blood samples drawn. These samples will be used to see how the disease is responding to the drug.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Therapy of Chronic Lymphocytic Leukemia With Dasatinib (BMS-354825)|
- Participants With Objective Response [ Time Frame: 4 week treatment cycle ] [ Designated as safety issue: No ]Number of participants with an Objective Response defined as Complete Response (CR) or Partial Response (PR). Responses evaluated every 3 months +/- 1 week by each component and overall by National Cancer Institute Working Group (NCIWG) criteria where Response judged, Nodes for CR: None; PR: > 50% decrease; Liver/Spleen CR: Not palpable; PR: > 50% decrease; Symptoms for CR: None; PR: Not applicable (N/A); polymorphonuclear leukocyte (PMN) for CR: >1,500/μl, PR: > 1,500/μl or >50% improvement from baseline; Platelets for CR: >100,000/μl, PR: >100,000/μl or > 50% improvement from baseline; Hemoglobin (untransfused) for CR: >11,0 g/dl; PR: >11.0 g/dl or >50% improvement from baseline; Lymphocytes for CR: <4,000/μl and PR: >50% decrease; Bone Marrow aspirate for CR: <30% lymphocytes, N/A for PR; Bone Biopsy for CR: No lymphocyte infiltrate; PR: < 30% lymphocytes with residual disease on biopsy for nodular PR.
|Study Start Date:||August 2006|
|Study Completion Date:||November 2012|
|Primary Completion Date:||November 2012 (Final data collection date for primary outcome measure)|
Dasatinib 50mg Orally twice daily.
Drug: Dasatinib (BMS-354825)
50mg Orally twice daily
Dasatinib is designed to interfere with a type of protein that appears to be important for the survival of CLL cells.
If you are found to be eligible to take part in this study, you will take dasatinib by mouth twice a day. You will be instructed to take dasatinib in the morning and in the evening.
You will have an electrocardiogram (ECG—a test of the electrical activity of your heart) and a physical exam once every 3 months while on study. Blood (about 2-3 teaspoons) will be drawn for routine tests once a week for 1 month and then once a month for the rest of your treatment on this study. A bone marrow biopsy and aspiration will be performed, as needed, to check the status of the disease. To collect a bone marrow aspirate and biopsy, an area of the hip or chest bone is numbed with anesthetic, and a small amount of bone marrow and bone is withdrawn through a large needle.
Dasatinib will be given for as long as you are responding. You will be taken off study if the disease gets worse or intolerable side effects occur.
This is an investigational study. Dasatinib is not FDA-approved for CLL, and it has been authorized for use in research only. Up to 25 patients will take part in this multicenter study. Up to 25 will be enrolled at M. D. Anderson.
Optional Procedures: If you agree, blood samples (about 2 tablespoons each time) will be collected before therapy starts, at 3-4 hours after the first dose, and at 3 months on therapy. These blood draws will be done when other routine tests are done. No additional needle sticks will be needed. The blood will be used to see how the disease is responding to the drug.
You do not have to agree to take part in the optional procedures in order to receive treatment on this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00364286
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Susan O'Brien, MD||M.D. Anderson Cancer Center|