Clinical trial NCT00349518: Study of Dasatinib in Imatinib Resistant or Intolerant Subjects With Chronic or Advanced Phase CML or Philadelphia Chromosome Positive ALL
Official title: A Phase II Study of Dasatinib (BMS-354825) in Subjects With Chronic or Advanced Phase Chronic Myelogenous Leukemia or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia Who Are Resistant or Intolerant to Imatinib
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
PHASE3
Conditions: Chronic Myeloid Leukemia
Acute Lymphoblastic Leukemia
Keywords: Chronic and Advanced Phase CML and
Philadelphia Chromosome Positive ALL with imatinib intolerance or resistance
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2006-07-07
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to further assess the safety of dasatinib in imatinib intolerant or resistant patients with chronic phase chronic myeloid leukemia, advanced phase chronic myeloid leukemia or Philadelphia chromosome positive acute lymphoblastic leukemia. The efficacy of the drug in this kind of patients will also further be documented.


Eligibility criteria: Inclusion Criteria:

* Males and females, 18 or older
* CP or AD CML or Ph+ ALL
* Intolerant of resistant to imatinib
* ECOG PS 0-2 (CP CML)
* ECOG PS 0-3 (AD CML and Ph+ ALL)
* Adequate hepatic and renal function

Exclusion Criteria:

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

Primary outcomes:
measure: Incidence and severity of drug-related adverse events.
Secondary outcomes:
measure: Chronic Phase CML: Cytogenetic and Hematologic Response
measure: Advanced Phase CML and Philadelphia positive ALL: Hematologic Response
measure: Time to and duration of Cytogenetic and Hematologic Response
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Local Institution
city: Bologna
country: Italy
facility: Local Institution
city: Orbassano (To)
country: Italy
facility: Local Institution
city: Roma
country: Italy
facility: Local Institution
city: Nijmegen
country: Netherlands
facility: Local Institution
city: Rotterdam
country: Netherlands
facility: Local Institution
city: Gdansk
country: Poland
facility: Local Institution
city: Katowice
country: Poland
facility: Local Institution
city: Krakow
country: Poland
facility: Local Institution
city: Lodz
country: Poland
facility: Local Instiution
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: Cambridge
country: United Kingdom
facility: Local Institution
state: Cambridgeshire
city: Glasgow
country: United Kingdom
facility: Local Institution
state: Central
city: London
country: United Kingdom
facility: Local Institution
state: Greater London
city: Liverpool
country: United Kingdom
facility: Local Institution
state: Merseyside
city: Newcastle
country: United Kingdom
facility: Local Institution
state: Tyne And Wear
city: Birmingham
country: United Kingdom
facility: Local Institution
state: West Midlands
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: