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Study of Dasatinib in Patients With Chronic Myelogenous Leukemia
Link to the ClinicalTrials.gov recordInformation obtained from ClinicalTrials.gov on February 23, 2012
Title of trial/grant titleStudy of Dasatinib in Patients With Chronic Myelogenous Leukemia
Current status of trialRecruiting
Sponsors and collaboratorsM.D. Anderson Cancer Center
Bristol-Myers Squibb
Information provided byM.D. Anderson Cancer Center
ClinicalTrials.gov identifierNCT00254423
PurposeThe goal of this clinical research study is to learn if BMS-354825 (dasatinib) can help to
control CML in chronic phase. The safety of this drug will also be studied.
Condition(s)Chronic Myelogenous Leukemia
Intervention(s)Drug: Dasatinib (BMS-354825)
PhasePhase II
Study type and designAllocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Official titleTherapy of Early Chronic Phase Chronic Myelogenous Leukemia (CML) With Dasatinib (BMS-354825)
Further study detailsDasatinib 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.

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 8-10 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.
Primary outcomeTime to first Molecular Response prior to 12 months (MMR) MMR measured every 3 months No
Study startNovember 2005
Minimum age16 Years
Maximum ageN/A
GenderBoth
Eligibility criteriaInclusion Criteria:

1. Diagnosis of Ph-positive or Bcr-Abl positive CML in early chronic phase CML (i.e.,
time from diagnosis received no or minimal prior therapy, defined as <1 month of prior IFN-alpha (with or
without ara-C) and/or imatinib

2. Continued from above #1: 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. Age >/= 16 years (Age >18 years to participate in optional symptom burden assessment)

4. ECOG performance of 0-2

5. Adequate end organ function, defined as the following: total bilirubin <1.5 x ULN,
SGPT <2.5x ULN, creatinine <1.5x ULN

6. 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.

7. Reliable telephone access to receive calls from an interactive voice response system
(IVR) (only applicable to patients who will participate in optional symptom burden
assessment)

Exclusion Criteria:

1. New York Heart Association (NYHA) cardiac class 3-4 heart disease

2. 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:

3. Cont: Diagnosed congenital bleeding disorders (von Willebrand's disease) Diagnosed
acquired bleeding disorder w/in 1 year (acquired anti-factor VIII antibodies);Pts
currently taking drugs that are generally accepted to have a risk of causing Torsades
de Pointes including: quinidine, procainamide, disopyramide amiodarone, sotalol,
ibutilide, dofetilide erythromycins, clarithromycin chlorpromazine, haloperidol,
mesoridazine, thioridazine, pimozide cisapride, bepridil, droperidol, methadone,
arsenic, chloroquine, domperidone, halofantrine, levomethadyl, pentamidine,
sparfloxacin, lidoflazine.

4. Patients with active, uncontrolled psychiatric disorders including: psychosis, major
depression, and bipolar disorders

5. 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.

6. Continued: In addition, men enrolled on this study should understand the risks to any
sexual partner of childbearing potential and should practice an effective method of
birth control. Women and men 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.

7. Patients in late chronic phase (i.e., time from diagnosis to treatment >12 months),
accelerated or blast phase are excluded.

8. The definitions of CML phases are as follows: a) Early chronic phase: time from
diagnosis to therapy 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: â¿¢Peripheral or marrow blasts 15% or more, â¿¢Peripheral or marrow
basophils 20% or more, â¿¢Thrombocytopenia < 100 x 10^9/L unrelated to therapy, â¿¢
Documented extramedullary blastic disease outside liver or spleen
Overall contactJorge Cortes, MD
tel: 713-794-5783
Study chairs or principal investigatorsJorge Cortes, MD, Principal Investigator, M.D. Anderson Cancer Center
LocationsTexas, United States

UT MD Anderson Cancer Center
Houston
Texas
77030
Status: Recruiting
Investigator: Jorge Cortes, MD, Principal Investigator
LinksM.D. Anderson's Website
Study ID numbers2005-0422
Last updatedNovember 7, 2011
Record first receivedNovember 14, 2005
ClinicalTrials.gov identifierNCT00254423
Download dateInformation obtained from ClinicalTrials.gov on February 23, 2012
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