Study of Dasatinib in Imatinib Resistant or Intolerant Subjects With Chronic or Advanced Phase CML or Philadelphia Chromosome Positive ALL

Acute Lymphoblastic Leukemia Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00349518
• Other study ID #: CA180-083
• Secondary ID: EUDRACTnr: 2006-
• Status: Withdrawn
• Phase: Phase 2/Phase 3
• First received: July 6, 2006
• Last updated: February 16, 2016
• Start date: December 2006

Study information

• Verified date: April 2011
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: January 2007
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abnormal Karyotype
• Acute Lymphoblastic Leukemia
• Chronic Myeloid Leukemia
• Leukemia
• Leukemia, Lymphoid
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Philadelphia Chromosome
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Drug:
• Dasatinib

Locations

Country	Name	City	State
Hungary	Local Institution	Budapest
Italy	Local Institution	Bologna
Italy	Local Institution	Orbassano (To)
Italy	Local Institution	Roma
Netherlands	Local Institution	Nijmegen
Netherlands	Local Institution	Rotterdam
Poland	Local Institution	Gdansk
Poland	Local Institution	Katowice
Poland	Local Institution	Krakow
Poland	Local Instiution	Lodz
Poland	Local Institution	Lublin
Poland	Local Institution	Warsaw
Russian Federation	Local Institution	Moscow
Russian Federation	Local Institution	St.Petersburg
United Kingdom	Local Institution	Birmingham	West Midlands
United Kingdom	Local Institution	Cambridge	Cambridgeshire
United Kingdom	Local Institution	Glasgow	Central
United Kingdom	Local Institution	Liverpool	Merseyside
United Kingdom	Local Institution	London	Greater London
United Kingdom	Local Institution	Newcastle	Tyne And Wear

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

Hungary,  Italy,  Netherlands,  Poland,  Russian Federation,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and severity of drug-related adverse events.
Secondary	Chronic Phase CML: Cytogenetic and Hematologic Response
Secondary	Advanced Phase CML and Philadelphia positive ALL: Hematologic Response
Secondary	Time to and duration of Cytogenetic and Hematologic Response

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm