This Study Will be a Phase IV, Open-label, Multicenter Study of Dasatinib in Chronic-Phase Chronic Myeloid Leukemia (CP-CML) Patients With Chronic, Low-grade Non-Hematologic Toxicity to Imatinib



Status:Completed
Conditions:Blood Cancer, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - Any
Updated:7/13/2016
Start Date:November 2012
End Date:October 2015

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A Phase IV, Open-label, Multicenter Study of Dasatinib in Chronic-Phase Chronic Myeloid Leukemia (CP-CML) Patients With Chronic, Low-grade Non-Hematologic Toxicity to Imatinib

This study proposes to evaluate the number of chronic, Grade 1 or 2, non-hematologic Adverse
Events (AEs) that reduce in grade or resolve at 3 months after switching therapy from
imatinib to dasatinib.


Inclusion Criteria:

- Patients with CML-CP patients achieving an optimal response to imatinib treatment
with Grade 1 or 2 non-hematologic adverse events persisting for at least 2 months or
recurring at least 3 times in the preceding 12 months, despite best supportive care

- Men and women with Chronic Myeloid Leukemia- Chronic Phase (CML-CP) Ph+ ≥ age 18

- Daily Eastern Co-Operative Group (ECOG) performance status = 0 - 2

- Patient willing and able to give informed consent

- Life expectancy > 6 months

- Adequate renal function

- Adequate hepatic function

Exclusion Criteria:

- Patients who are pregnant or breast feeding

- Men whose partner is unwilling to avoid pregnancy.

- Previous treatment with any other tyrosine-kinase inhibitor (TKI), except for
imatinib

- Current grade 3 or 4 imatinib related adverse event

- Prior documented T315I mutation

- Prior diagnosis of accelerated phase or blast crisis CML

- Previous loss of complete hematologic response (CHR) or major cytogenetic response
(MCyR) on imatinib

- Concurrent medical condition of uncontrolled infection, cardiovascular diseases of
cardiac failure, congenital long QT syndrome, ventricular arrhythmias, prolonged QT
interval, second or third degree heart block, uncontrolled angina, myocardial
infarction (MI) in the last 6 months, uncontrolled hypertension, pulmonary arterial
hypertension, pleural or pericardial effusions, or history of bleeding disorder
We found this trial at
6
sites
Anaheim, California 92801
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Anaheim, CA
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Baltimore, Maryland 21229
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Baltimore, MD
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Creteil Cedex, 94010
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Creteil Cedex,
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1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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Houston, TX
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Southington, Connecticut 06489
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Southington, CT
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Sylvania, OH
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