Study of Dasatinib vs Imatinib in Patients With Chronic Myeloid Leukemia (CML) Who Did Not Have Favorable Response to Imatinib



Status:Active, not recruiting
Conditions:Blood Cancer, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - Any
Updated:9/16/2017
Start Date:October 29, 2012
End Date:February 17, 2022

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An Open Label, Randomized (2:1) Phase IIb Study of Dasatinib Versus Imatinib in Patients With Chronic Phase Chronic Myeloid Leukemia Who Have Not Achieved an Optimal Response to 3 Months of Therapy With 400 mg Imatinib

The purpose of this study is to test the hypothesis that patients with CML who have not
achieved optimal response after 3 months of treatment with imatinib will have a better
response by switching to dasatinib compared to staying on their original imatinib regimen.


For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com.

Inclusion Criteria:

- Chronic Phase (CP)-CML Ph+ patients with complete hematologic response (CHR) but with
one log BCR-ABL reduction (BCR-ABL level >10% IS) 3 months of imatinib 400mg
treatment. (Imatinib transient dose adjustments due to Adverse Event (AEs) are allowed
with a maximum of 2 weeks interruption of treatment with imatinib (cumulative) within
the 3 month period before randomization). Imatinib monotherapy must have been started
within 6 months of CP-CML diagnosis (Ph + /BCR-ABL detection)

- Currently tolerating imatinib 400mg QD. Patients with prior imatinib treatment
interruption or dose reductions are required to be on treatment with 400 mg imatinib
for two weeks immediately prior to randomization to ensure tolerance to imatinib

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

- Adequate renal function defined as serum creatinine ≤3 times the institutional upper
limit of normal (ULN)

- Adequate hepatic function defined as: total bilirubin ≤2.0 times the institutional
ULN; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 times
the institutional ULN

Exclusion Criteria:

- Previous diagnosis of accelerated phase or blast crisis

- Subjects with clonal evolution in Ph+ cells observed in ≥2 metaphases at baseline bone
marrow cytogenetic test, unless the same abnormalities were present at diagnosis.
Patients with no evidence of clonal evolution, including those patients whose
cytogenetic testing fails or bone marrow aspiration is a dry tap at 3 months, are
eligible for the study

- Subjects with less than CHR after 3 months of imatinib treatment or lost CHR after
initial achievement

- Documented T315I/A, F317L, or V299L mutations (if already available - not required for
screening)

- A serious uncontrolled medical disorder or active infection that would impair the
ability of the subject to receive protocol therapy
We found this trial at
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Anaheim, California 92801
Phone: 714-999-1465
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101 Jessup Hall
Iowa City, Iowa 52242
(319) 335-3500
University of Iowa With just over 30,000 students, the University of Iowa is one of...
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4350 Malsbary Road
Cincinnati, Ohio 45242
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Ciudad Autonoma de Buenos Aires, Buenos Aires
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Evanston, Illinois 60208
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Fontana, California 92335
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2002 Holcombe Boulevard
Houston, Texas 77030
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Huntington, West Virginia 25701
Phone: 304-399-6521
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Indianapolis, Indiana 46237
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9200 W Wisconsin Ave
Milwaukee, Wisconsin 53226
(414) 805-3666
Froedtert and the Medical College of Wisconsin Froedtert Health combines with the Medical College of...
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250 25th Avenue North
Nashville, Tennessee 37203
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Pittsburgh, Pennsylvania 15232
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Rochester, Minnesota 55905
Phone: 507-538-0591
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615 N Michigan Street
South Bend, Indiana 46601
(574) 647-7370
Northern Indiana Cancer Research Consortium The Northern Indiana Cancer Research Consortium (NICRC) is comprised of...
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Southington, Connecticut 06489
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602 W University Ave
Urbana, Illinois 61801
(217) 383-3010
Carle Cancer Center Carle Cancer Center delivers comprehensive care through leading-edge technology and advanced research,...
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Vallejo, California 94589
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Whittier, California 90603
Phone: 562-693-4477
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