Phase I Study of Dasatinib (BMS-354825) and Imatinib in Subjects With Chronic Myeloid Leukemia in Chronic Phase

Withdrawn before enrolling · Phase 1

Conditions studied: Myeloid Leukemia, Chronic, Chronic-Phase

In brief

The purpose of this study is to find out whether adding a new drug, dasatinib, to imatinib is safe, and whether the combination of the two drugs will help decrease the number of cells that contain the Philadelphia chromosome.

Key facts

Study ID

NCT00324077

Run by

Bristol-Myers Squibb

People needed

0

Starts

2006-08-01

Last updated by the study team

2016-02-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• males and females, 18 or older
• chronic phase Ph+ or BCR-ABL positive CML
• current complete hematologic response to imatinib
• lack of major molecular response
• on imatinib for at least one year
• on the same imatinib dose for at least 6 months
• adequate hepatic and renal function

You may not qualify if…

• History of accelerated or blast phase CML
• Serious uncontrolled medical disorder or active infection
• Significant cardiovascular disease or bleeding disorder
• Concurrent use of medications at risk of causing Torsades de Pointe

Where it is running

• Local Institution — Los Angeles, California, United States
• Local Institution — San Francisco, California, United States
• Local Institution — New York, New York, United States

Full record on ClinicalTrials.gov

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