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Sponsors and Collaborators: |
M.D. Anderson Cancer Center Bristol-Myers Squibb |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00254423 |
The goal of this clinical research study is to learn if BMS-354825 (dasatinib) can help to control chronic myelogenous leukemia (CML) in chronic phase. The safety of this drug will also be studied.
Condition | Intervention | Phase |
---|---|---|
Chronic Myelogenous Leukemia |
Drug: Dasatinib (BMS-354825) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Therapy of Early Chronic Phase Chronic Myelogenous Leukemia (CML) With Dasatinib (BMS-354825) |
Estimated Enrollment: | 150 |
Study Start Date: | November 2005 |
Estimated Study Completion Date: | September 2010 |
Estimated Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Dasatinib Daily (Arm A): Experimental |
Drug: Dasatinib (BMS-354825)
Arm A: Starting dose 100 mg orally daily Arm B: Starting dose of 50 mg orally twice daily |
Dasatinib Twice Daily (Arm B): Experimental |
Drug: Dasatinib (BMS-354825)
Arm A: Starting dose 100 mg orally daily Arm B: Starting dose of 50 mg orally twice daily |
Dasatinib is an anticancer drug that is designed to block the function of BCR-ABL, which is the abnormal protein responsible for causing leukemia in certain cells.
Before you can start therapy on this study, you will have what are called "screening tests." These tests will help the doctor decide if you are eligible to take part in the study. You will have a complete medical history and physical exam. Blood (about 2 tablespoons) will be collected for routine tests. You will also have a bone marrow biopsy and aspiration. To collect a bone marrow biopsy and aspiration, an area of the hip or chest bone is numbed with anaesthetic and a small amount of bone marrow and bone is withdrawn through a large needle. Women who are able to have children must have a negative blood or urine pregnancy test.
If you are found to be eligible to take part in this study and you agree, you will take dasatinib once every day while on study. Dasatinib should be taken by mouth with water.
Every 1-2 weeks during the first 4 weeks of the study, you will have around 2 tablespoons of blood drawn for routine blood tests. The blood tests will be repeated every 4-6 weeks until 1 year from when you started therapy and then every 3-4 months until 2 years, then every 4-6 months for as long as you are on the study. A bone marrow aspiration will also be taken every 3-4 months for the first year and then every 6-12 months until 3 years then every 2-3 years for as long as you are on the study to check on the status of the disease.
You will be given a medication diary to monitor any missed doses. You will also be asked to visit the doctor for a physical exam and to have vital signs measured periodically. These visits will be scheduled at least every 3-4 months for the first year, then every 6 to 12 months while you are on the study. The visits may be scheduled more often depending on the status of the disease.
Treatment may be continued for up to 3-5 years or as long as the doctor feels it is necessary to control the leukemia. If the disease gets worse or you experience any intolerable side effects, you will be taken off the study and your doctor will discuss other treatment options with you. If you decide to stop participating in the study, you are encouraged to discuss your decision with your study doctor.
For Patients Already Enrolled:
If you have already been enrolled on this study and were assigned to receive dasatinib twice a day, you will be able to continue to receive the study drug on that schedule. However, if you experience side effects, the study doctor may choose to switch you to the once daily schedule if he feels that it may help to get rid of or decrease the risk of side effects.
This is an investigational study. Dasatinib is investigational and is approved by the FDA for clinical trials only. A total of 150 patients will take part in this study. All will be enrolled at M. D. Anderson.
Ages Eligible for Study: | 16 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Cardiac Symptoms: Patients meeting the following criteria are not eligible: Uncontrolled angina within 3 months; Diagnosed or suspected congenital long QT syndrome; Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de pointes); Prolonged QTc interval on pre-entry electrocardiogram (> 450 msec) on both the Fridericia and Bazett's correction;
Uncontrolled hypertension; History of significant bleeding disorder unrelated to cancer, including:
The definitions of CML phases are as follows: a) Early chronic phase: time from diagnosis to therapy </= 12 months; Late chronic phase: time from diagnosis to therapy > 12 months, b) Blastic phase: presence of 30% blasts or more in the peripheral blood or bone marrow, c) Accelerated phase CML: presence of any of the following features: •Peripheral or marrow blasts 15% or more, •Peripheral or marrow basophils 20% or more,
Contact: Jorge Cortes, MD | 713-794-5783 |
United States, Texas | |
U.T.M.D. Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Principal Investigator: Jorge Cortes, MD |
Principal Investigator: | Jorge Cortes, MD | U.T.M.D. Anderson Cancer Center |
Responsible Party: | The University of Texas M. D. Anderson Cancer Center ( Jorge Cortes M.D./Professor ) |
Study ID Numbers: | 2005-0422 |
Study First Received: | November 14, 2005 |
Last Updated: | August 24, 2009 |
ClinicalTrials.gov Identifier: | NCT00254423 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Chronic Myelogenous Leukemia CML Dasatinib BMS-354825 |
Leukemia Hematologic Diseases Dasatinib Myeloproliferative Disorders Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
Chronic Myelogenous Leukemia Leukemia, Myeloid, Chronic-Phase Leukemia, Myeloid Bone Marrow Diseases Protein Kinase Inhibitors |
Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Hematologic Diseases Myeloproliferative Disorders Enzyme Inhibitors Leukemia, Myeloid Leukemia, Myeloid, Chronic-Phase |
Protein Kinase Inhibitors Pharmacologic Actions Leukemia Neoplasms Dasatinib Leukemia, Myelogenous, Chronic, BCR-ABL Positive Bone Marrow Diseases |