A Study of Dasatinib in Patients With Chronic Myelogenous Leukemia Who Are Resistant or Intolerant of Imatinib Mesylate

Sponsor

Bristol-Myers Squibb (Industry)

Overall Status

Completed

CT.gov ID

NCT00298987

Collaborator

(none)

400

Enrollment

Locations

Arm

15.9

Duration (Months)

11.4

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this clinical research study is to provide dasatinib treatment to patients with advanced chronic myelogenous leukemia (CML) or Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) who no longer can tolerate treatment with imatinib. The safety of the treatment will also be studied.

Condition or Disease	Intervention/Treatment	Phase
Leukemia, Myeloid, Chronic Leukemia, Lymphocytic, Acute, L2	Drug: Dasatinib	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

400 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Study of Dasatinib (BMS-354825) in Subjects With Chronic Myelogenous Leukemia With Accelerated or Myeloid or Lymphoid Blast Phase or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia Who Are Resistant to or Intolerant of Imatinib Mesylate

Study Start Date :

Feb 1, 2006

Actual Primary Completion Date :

Jun 1, 2007

Actual Study Completion Date :

Jun 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A1	Drug: Dasatinib Tablets, Oral, 70 mg, Twice daily, 2 months. Other Names: Sprycel

Arm

Intervention/Treatment

Experimental: A1

Drug: Dasatinib

Tablets, Oral, 70 mg, Twice daily, 2 months.

Other Names:

Sprycel

Outcome Measures

Primary Outcome Measures

Provide therapy to patients for which there is no therapeutic alternative []

Secondary Outcome Measures

Safety data collection []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Diagnosis of accelerated phase or blast phase CML or Ph+ ALL
Intolerant or resistant to imatinib mesylate
18 years of age or older
ECOG performance 0-2 (greater than 50% of time out of bed)
Adequate liver and kidney function

Exclusion Criteria:

Pregnant or breastfeeding females
History of significant cardiac disease
History of significant bleeding disorder (not CML)
Prisoners

Contacts and Locations

Locations

	Site	City	State	Country
1	Local Institution	Corona	California	United States
2	Local Institution	Aurora	Colorado	United States
3	Local Institution	Colorado Springs	Colorado	United States
4	Local Institution	Waterford	Connecticut	United States
5	Local Institution	Daytona Beach	Florida	United States
6	Local Institution	Jupiter	Florida	United States
7	Local Institution	Atlanta	Georgia	United States
8	Local Institution	Lawrenceville	Georgia	United States
9	Local Institution	Beach Grove	Indiana	United States
10	Local Institution	Indianapolis	Indiana	United States
11	Local Institution	Iowa City	Iowa	United States
12	Local Institution	Kansas City	Kansas	United States
13	Local Institution	Salina	Kansas	United States
14	Local Institution	Lexington	Kentucky	United States
15	Local Institution	Louisville	Kentucky	United States
16	Local Institution	Boston	Massachusetts	United States
17	Local Institution	Ann Arbor	Michigan	United States
18	Local Institution	Detroit	Michigan	United States
19	Local Institution	Santa Fe	New Mexico	United States
20	Local Institution	New York	New York	United States
21	Local Institution	Cincinnati	Ohio	United States
22	Local Institution	Cleveland	Ohio	United States
23	Local Institution	Lawton	Oklahoma	United States
24	Local Institution	Tulsa	Oklahoma	United States
25	Local Institution	Portland	Oregon	United States
26	Local Institution	Providence	Rhode Island	United States
27	Local Institution	Charleston	South Carolina	United States
28	Local Institution	Chattanooga	Tennessee	United States
29	Local Institution	Spokane	Washington	United States
30	Local Institution	Sheboygan	Wisconsin	United States
31	Local Institution	Edmonton	Alberta	Canada
32	Local Institution	Vancouver	British Columbia	Canada
33	Local Institution	Hamilton	Ontario	Canada
34	Local Institution	Toronto	Ontario	Canada
35	Local Institution	Montreal	Quebec	Canada