Back to resultsStudy of Dasatinib in Imatinib Resistant or Intolerant Subjects With Chronic or Advanced Phase CML or Philadelphia Chromosome Positive ALL
Primary Purpose
Chronic Myeloid Leukemia, Acute Lymphoblastic Leukemia
Status
Withdrawn
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Dasatinib
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Myeloid Leukemia focused on measuring Chronic and Advanced Phase CML and, Philadelphia Chromosome Positive ALL with imatinib intolerance or resistance
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)
Sites / Locations
- Local Institution
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Outcomes
Primary Outcome Measures
Incidence and severity of drug-related adverse events.
Secondary Outcome Measures
Chronic Phase CML: Cytogenetic and Hematologic Response
Advanced Phase CML and Philadelphia positive ALL: Hematologic Response
Time to and duration of Cytogenetic and Hematologic Response
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00349518
Brief Title
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
2. Study Status
Record Verification Date
April 2011
Overall Recruitment Status
Withdrawn
Study Start Date
December 2006 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Bristol-Myers Squibb
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Myeloid Leukemia, Acute Lymphoblastic Leukemia
Keywords
Chronic and Advanced Phase CML and, Philadelphia Chromosome Positive ALL with imatinib intolerance or resistance
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Dasatinib
Primary Outcome Measure Information:
Title
Incidence and severity of drug-related adverse events.
Secondary Outcome Measure Information:
Title
Chronic Phase CML: Cytogenetic and Hematologic Response
Title
Advanced Phase CML and Philadelphia positive ALL: Hematologic Response
Title
Time to and duration of Cytogenetic and Hematologic Response
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution
City
Budapest
Country
Hungary
Facility Name
Local Institution
City
Bologna
Country
Italy
Facility Name
Local Institution
City
Orbassano (To)
Country
Italy
Facility Name
Local Institution
City
Roma
Country
Italy
Facility Name
Local Institution
City
Nijmegen
Country
Netherlands
Facility Name
Local Institution
City
Rotterdam
Country
Netherlands
Facility Name
Local Institution
City
Gdansk
Country
Poland
Facility Name
Local Institution
City
Katowice
Country
Poland
Facility Name
Local Institution
City
Krakow
Country
Poland
Facility Name
Local Instiution
City
Lodz
Country
Poland
Facility Name
Local Institution
City
Lublin
Country
Poland
Facility Name
Local Institution
City
Warsaw
Country
Poland
Facility Name
Local Institution
City
Moscow
Country
Russian Federation
Facility Name
Local Institution
City
St.Petersburg
Country
Russian Federation
Facility Name
Local Institution
City
Cambridge
State/Province
Cambridgeshire
Country
United Kingdom
Facility Name
Local Institution
City
Glasgow
State/Province
Central
Country
United Kingdom
Facility Name
Local Institution
City
London
State/Province
Greater London
Country
United Kingdom
Facility Name
Local Institution
City
Liverpool
State/Province
Merseyside
Country
United Kingdom
Facility Name
Local Institution
City
Newcastle
State/Province
Tyne And Wear
Country
United Kingdom
Facility Name
Local Institution
City
Birmingham
State/Province
West Midlands
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Study of Dasatinib in Imatinib Resistant or Intolerant Subjects With Chronic or Advanced Phase CML or Philadelphia Chromosome Positive ALL
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