Clinical trial NCT00298987: A Study of Dasatinib in Patients With Chronic Myelogenous Leukemia Who Are Resistant or Intolerant of Imatinib Mesylate
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Leukemia, Myeloid, Chronic
Leukemia, Lymphocytic, Acute, L2
Keywords: Chronic Myeloid Leukemia Accelerated and Blast Phase
Leukemia, Acute, Philadelphia-Positive
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2006-03-06
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Provide therapy to patients for which there is no therapeutic alternative
Secondary outcomes:
measure: Safety data collection
Other outcomes:
Locations:
city: Corona
country: United States
facility: Local Institution
state: California
city: Aurora
country: United States
facility: Local Institution
state: Colorado
city: Colorado Springs
country: United States
facility: Local Institution
state: Colorado
city: Waterford
country: United States
facility: Local Institution
state: Connecticut
city: Daytona Beach
country: United States
facility: Local Institution
state: Florida
city: Jupiter
country: United States
facility: Local Institution
state: Florida
city: Atlanta
country: United States
facility: Local Institution
state: Georgia
city: Lawrenceville
country: United States
facility: Local Institution
state: Georgia
city: Beach Grove
country: United States
facility: Local Institution
state: Indiana
city: Indianapolis
country: United States
facility: Local Institution
state: Indiana
city: Iowa City
country: United States
facility: Local Institution
state: Iowa
city: Kansas City
country: United States
facility: Local Institution
state: Kansas
city: Salina
country: United States
facility: Local Institution
state: Kansas
city: Lexington
country: United States
facility: Local Institution
state: Kentucky
city: Louisville
country: United States
facility: Local Institution
state: Kentucky
city: Boston
country: United States
facility: Local Institution
state: Massachusetts
city: Ann Arbor
country: United States
facility: Local Institution
state: Michigan
city: Detroit
country: United States
facility: Local Institution
state: Michigan
city: Santa Fe
country: United States
facility: Local Institution
state: New Mexico
city: New York
country: United States
facility: Local Institution
state: New York
city: Cincinnati
country: United States
facility: Local Institution
state: Ohio
city: Cleveland
country: United States
facility: Local Institution
state: Ohio
city: Lawton
country: United States
facility: Local Institution
state: Oklahoma
city: Tulsa
country: United States
facility: Local Institution
state: Oklahoma
city: Portland
country: United States
facility: Local Institution
state: Oregon
city: Providence
country: United States
facility: Local Institution
state: Rhode Island
city: Charleston
country: United States
facility: Local Institution
state: South Carolina
city: Chattanooga
country: United States
facility: Local Institution
state: Tennessee
city: Spokane
country: United States
facility: Local Institution
state: Washington
city: Sheboygan
country: United States
facility: Local Institution
state: Wisconsin
city: Edmonton
country: Canada
facility: Local Institution
state: Alberta
city: Vancouver
country: Canada
facility: Local Institution
state: British Columbia
city: Hamilton
country: Canada
facility: Local Institution
state: Ontario
city: Toronto
country: Canada
facility: Local Institution
state: Ontario
city: Montreal
country: Canada
facility: Local Institution
state: Quebec
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: