Clinical trial NCT00982488: Long-term Safety of Dasatinib in Patients With Chronic Myelogenous Leukemia or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia
Official title: Dasatinib in Chronic Myelogenous Leukemia or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemic Subjects Who Are Experiencing Clinical Benefit on Current START or CA180-039 Protocols: Long Term Safety and Efficacy Analysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Leukemia
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2009-09-23
Enrollment: 238
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study assesses the long-term safety and tolerability of dasatinib administered to patients with chronic myelogenous leukemia or Philadelphia chromosome positive acute lymphoblastic leukemia and experienced clinical benefit from treatment with dasatinib or imatinib in previous protocols.


Eligibility criteria: Key Inclusion Criteria

* Signed written informed consent
* Received treatment in protocols CA180-005, CA180-006, CA180-013, CA180-015 or CA180-017, or CA180-039
* Received clinical benefit with dasatinib or imatinib (study CA180017) in the opinion of the Investigator
* Men and women, ages 18 and older

Key Exclusion Criteria

* A serious uncontrolled medical disorder or active infection that would impair the ability of the patient to receive protocol therapy
* Dementia or altered mental status that would prohibit the understanding or rendering of informed consent
* Patients currently taking drugs, including but not limited to quinidine, procainamide, disopyramide, amiodarone, sotalol, ibutilide, dofetilide, erythromycins, clarithromycin, chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide, ziprasidone, cisapride, bepridil, droperidol, methadone, arsenic, chloroquine, domperidone, halofantrine, levomethadyl, pentamidine, sparfloxacin, and lidoflazine, which are generally accepted to have a risk of causing Torsades de Pointes
* Patients taking medications known to be potent CYP3A4 inhibitors (ketoconazole, ritonavir) or inducers (rifampin, efavirenz)

Primary outcomes:
measure: Number of Participants Who Died and Had Serious Adverse Events (SAEs), Related SAEs, Adverse Events (AEs) Leading to Discontinuation, Related AEs Leading to Discontinuation, Related AEs, and Related AEs of Special Interest
timeFrame: Day 1 of treatment through a maximum of 82 months + 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Pacific Cancer Medical Center Inc
state: California
city: Loma Linda
country: United States
facility: Loma Linda University Cancer Center
state: California
city: Los Angeles
country: United States
facility: Ucla Department Of Medicine
state: California
city: Stanford
country: United States
facility: Stanford University School Of Medicine
state: California
city: Vallejo
country: United States
facility: Kaiser Permanente Medical Center
state: California
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center & Research Institute
state: Florida
city: Chicago
country: United States
facility: University Of Chicago
state: Illinois
city: Indianapolis
country: United States
facility: Central Indiana Cancer Centers
state: Indiana
city: Westwood
country: United States
facility: University Of Kansas Medical Center
state: Kansas
city: Boston
country: United States
facility: Dana Faber Cancer Institute
state: Massachusetts
city: Ann Arbor
country: United States
facility: University Of Michigan Medical Center
state: Michigan
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
city: Hackensack
country: United States
facility: John Theurer Cancer Center
state: New Jersey
city: Portland
country: United States
facility: Oregon Health & Sci Univ
state: Oregon
city: Pittsburgh
country: United States
facility: Western Pennsylvania Hospital
state: Pennsylvania
city: Dallas
country: United States
facility: Ut Southwestern Medical Center At Dallas
state: Texas
city: Houston
country: United States
facility: The University Of Texas Md Anderson Cancer Center
state: Texas
city: Capital Federal
country: Argentina
facility: Local Institution
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Local Institution
city: Buenos Aires
country: Argentina
facility: Local Institution
city: Adelaide
country: Australia
facility: Local Institution
state: South Australia
city: Mont-godinne
country: Belgium
facility: Local Institution
city: Curitiba
country: Brazil
facility: Local Institution
state: Parana
city: Campinas
country: Brazil
facility: Local Institution
state: San Paulo
city: Rio de Janeiro
country: Brazil
facility: Local Institution
city: Sao Paulo
country: Brazil
facility: Local Institution
city: Sao Paulo
country: Brazil
facility: Local Institution
city: Toronto
country: Canada
facility: Local Institution
state: Ontario
city: Montreal
country: Canada
facility: Local Institution
state: Quebec
city: Helsinki
country: Finland
facility: Local Institution
city: Lille
country: France
facility: Local Institution
city: Lyon Cedex 03
country: France
facility: Local Institution
city: Nantes
country: France
facility: Local Institution
city: Paris
country: France
facility: Local Institution
city: Pessac
country: France
facility: Local Institution
city: Poitiers Cedex
country: France
facility: Local Institution
city: Strasbourg
country: France
facility: Local Institution
city: Hamburg
country: Germany
facility: Local Institution
city: Leipzig
country: Germany
facility: Local Institution
city: Mannheim
country: Germany
facility: Local Institution
city: Budapest
country: Hungary
facility: Local Institution
city: Dublin 8
country: Ireland
facility: Local Institution
state: Dublin
city: Ramat-gan
country: Israel
facility: Local Institution
city: Bologna
country: Italy
facility: Local Institution
city: Napoli
country: Italy
facility: Local Institution
city: Orbassano (to)
country: Italy
facility: Local Institution
city: Roma
country: Italy
facility: Local Institution
city: Jeollanam-do
country: Korea, Republic of
facility: Local Institution
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Trondheim
country: Norway
facility: Local Institution
city: Lima
country: Peru
facility: Local Institution
city: Lima
country: Peru
facility: Local Institution
city: Katowice
country: Poland
facility: Local Institution
city: Krakow
country: Poland
facility: Local Institution
city: Lodz
country: Poland
facility: Local Institution
city: Lublin
country: Poland
facility: Local Institution
city: Warsaw
country: Poland
facility: Local Institution
city: Moscow
country: Russian Federation
facility: Local Institution
city: St.petersburg
country: Russian Federation
facility: Local Institution
city: Groenkloof
country: South Africa
facility: Local Institution
state: Gauteng
city: Parktown
country: South Africa
facility: Local Institution
state: Gauteng
city: Barcelona
country: Spain
facility: Local Institution
city: Gothenburg
country: Sweden
facility: Local Institution
city: Lund
country: Sweden
facility: Local Institution
city: Stockholm
country: Sweden
facility: Local Institution
city: Umea
country: Sweden
facility: Local Institution
city: Uppsala
country: Sweden
facility: Local Institution
city: Basel
country: Switzerland
facility: Local Institution
city: Bangkok
country: Thailand
facility: Local Institution
city: London
country: United Kingdom
facility: Local Institution
state: Greater London
city: Glasgow
country: United Kingdom
facility: Local Institution
state: Scotland
city: Newcastle
country: United Kingdom
facility: Local Institution
state: Tyne And Wear
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: