Leukemia, Myeloid, Chronic Clinical Trial
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
| Verified date | June 2008 |
| Source | Bristol-Myers Squibb |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 400 |
| Est. completion date | June 2007 |
| Est. primary completion date | June 2007 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Canada | Local Institution | Edmonton | Alberta |
| Canada | Local Institution | Hamilton | Ontario |
| Canada | Local Institution | Montreal | Quebec |
| Canada | Local Institution | Toronto | Ontario |
| Canada | Local Institution | Vancouver | British Columbia |
| United States | Local Institution | Ann Arbor | Michigan |
| United States | Local Institution | Atlanta | Georgia |
| United States | Local Institution | Aurora | Colorado |
| United States | Local Institution | Beach Grove | Indiana |
| United States | Local Institution | Boston | Massachusetts |
| United States | Local Institution | Charleston | South Carolina |
| United States | Local Institution | Chattanooga | Tennessee |
| United States | Local Institution | Cincinnati | Ohio |
| United States | Local Institution | Cleveland | Ohio |
| United States | Local Institution | Colorado Springs | Colorado |
| United States | Local Institution | Corona | California |
| United States | Local Institution | Daytona Beach | Florida |
| United States | Local Institution | Detroit | Michigan |
| United States | Local Institution | Indianapolis | Indiana |
| United States | Local Institution | Iowa City | Iowa |
| United States | Local Institution | Jupiter | Florida |
| United States | Local Institution | Kansas City | Kansas |
| United States | Local Institution | Lawrenceville | Georgia |
| United States | Local Institution | Lawton | Oklahoma |
| United States | Local Institution | Lexington | Kentucky |
| United States | Local Institution | Louisville | Kentucky |
| United States | Local Institution | New York | New York |
| United States | Local Institution | Portland | Oregon |
| United States | Local Institution | Providence | Rhode Island |
| United States | Local Institution | Salina | Kansas |
| United States | Local Institution | Santa Fe | New Mexico |
| United States | Local Institution | Sheboygan | Wisconsin |
| United States | Local Institution | Spokane | Washington |
| United States | Local Institution | Tulsa | Oklahoma |
| United States | Local Institution | Waterford | Connecticut |
| Lead Sponsor | Collaborator |
|---|---|
| Bristol-Myers Squibb |
United States, Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Provide therapy to patients for which there is no therapeutic alternative | |||
| Secondary | Safety data collection |
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