The goal of this clinical research study is to learn if giving half of the recommended FDA
approved dose of dasatinib can help to control CML as effectively as the full dose of
Study Drug Administration:
If you are found to be eligible to take part in this study, you will take dasatinib tablets
by mouth one (1) time each day. You should take each dose of dasatinib with a meal.
The dose of dasatinib you receive may be changed if the study doctor thinks it is in your
Every 1-2 weeks for the first 4 weeks, every 2-6 weeks after that for the first 3 months,
then every 3 months after that during Year 1, and then every 3-6 months until Year 2, blood
(about 2 teaspoons) will be drawn for routine tests.
You may have this blood draw more or less often, if the study doctor thinks it is needed.
If it is more convenient to you and the study doctor agrees, you may be able to have these
blood draws and physical exams performed at a local lab or by a doctor closer to your home.
The results of these tests will be sent to the study doctor at MD Anderson for review. The
study doctor will discuss this option with you.
At Months 3, 6, 9, and 12, you will have a physical exam and blood (about 2 teaspoons) will
be drawn to check the status of the disease.
After the first year, you will have a physical exam every 6-12 months. You may also be
called to ask if you have had any side effects. Each phone call should take about 5 minutes.
Length of Study:
You may continue to take dasatinib for up to 15 years. You will no longer be able to take
the study drug if the disease gets worse, if intolerable side effects occur, or if you are
unable to follow study directions.
Your participation in this study will be over after your last dose of study drug.
This is an investigational study. Dasatinib is FDA approved and commercially available for
the treatment of CML. It is considered investigational to give a lower dose of dasatinib to
treat CML. The study doctor can explain how the study drug is designed to work.
Up to 100 participants will take part in this study. All will be enrolled at MD Anderson.
1. Diagnosis of Ph-positive or BCR-ABL positive CML in early chronic phase CML (i.e.,
time from diagnosis 12 months). Except for hydroxyurea, patients must have received
no or minimal prior therapy, defined as <1 month (30 days) of prior FDA approved TKI.
2. Clonal evolution defined as the presence of additional chromosomal abnormalities
other than the Ph chromosome has been historically been included as a criterion for
accelerated phase. However, patients with clonal evolution as the only criterion of
accelerated phase have a significantly better prognosis, and when present at
diagnosis may not impact the prognosis at all. Thus, patients with clonal evolution
and no other criteria for accelerated phase will be eligible for this study.
3. ECOG performance of 0-2.
4. Adequate end organ function, defined as the following: total bilirubin <1.5x ULN,
SGPT <2.5x ULN, creatinine <1.5x ULN.
5. 4.4 Patients must sign an informed consent indicating they are aware of the
investigational nature of this study, in keeping with the policies of the hospital.
1. NYHA cardiac class 3-4 heart disease
2. Cardiac Symptoms: Patients meeting the following criteria are not eligible unless
cleared by Cardiology: 1. Uncontrolled angina within 3 months. 2.Diagnosed or
suspected congenital long QT syndrome. 3. Any history of clinically significant
ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation,
or Torsades de pointes). 4. Prolonged QTc interval on pre-entry electrocardiogram (>
460 msec). 5.History of significant bleeding disorder unrelated to cancer, including:
Diagnosed congenital bleeding disorders (e.g., von Willebrand's disease) Diagnosed
acquired bleeding disorder within one year (e.g., acquired anti-factor VIII
3. Patients with active, uncontrolled psychiatric disorders include: psychosis, major
depression, and bipolar disorders.
4. Women of pregnancy potential must practice an effective method of birth control
during the course of the study, in a manner such that risk of failure is minimized.
Prior to study enrollment, women of childbearing potential (WOCBP) must be advised of
the importance of avoiding pregnancy during trial participation and the potential
risk factors for an unintentional pregnancy. Postmenopausal women must be amenorrheic
for at least 12 months to be considered of non-childbearing potential. Women must
continue birth control for the duration of the trial and at least 3 months after the
last dose of study drug. Pregnant or breast-feeding women are excluded. All WOCBP
must have a negative pregnancy test prior to first receiving investigational product.
If the pregnancy test is positive, the patient must not receive investigational
product and must not be enrolled in the study.
5. Patients in late chronic phase (i.e., time from diagnosis to treatment >12 months),
accelerated or blast phase are excluded. 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 • Thrombocytopenia < 100 x 109/L
unrelated to therapy • Documented extramedullary blastic disease outside liver or