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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00123487




Registration number
NCT00123487
Ethics application status
Date submitted
21/07/2005
Date registered
25/07/2005
Date last updated
2/11/2014

Titles & IDs
Public title
Advanced Chronic Myelogenous Leukemia (CML) - Follow On: Study of BMS-354825 in Subjects With CML
Scientific title
A Randomized Two-Arm, Multicenter, Open-Label Phase III Study of BMS-354825 Administered Orally at a Dose of 70 mg Twice Daily or 140 mg Once Daily in Subjects With Chronic Myeloid Leukemia in Accelerated Phase or in Myeloid or Lymphoid Blast Phase or With Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia Who Are Resistant or Intolerant to Imatinib Mesylate (Gleevec)
Secondary ID [1] 0 0
CA180-035
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myeloid Leukemia, Chronic, Accelerated Phase 0 0
Leukemia, Lymphoblastic, Acute, Philadelphia-Positive 0 0
Condition category
Condition code
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - dasatinib
Treatment: Drugs - dasatinib

Experimental: dasatinib Twice a Day (BID) - 70 mg dasatinib twice a day (BID)

Experimental: dasatinib Once a Day (QD) - 140 mg dasatinib once a day (QD)


Treatment: Drugs: dasatinib
Tablets, Oral, 70 mg BID, indefinitely, survival study

Treatment: Drugs: dasatinib
Tablets, Oral, 140 mg QD, indefinitely, survival study
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percent of Participants With Major Hematologic Response (MaHR) With 6 Months of Follow-up From Date of Last Enrollment - Randomized Population
Timepoint [1] 0 0
Randomization up to 6 months
Secondary outcome [1] 0 0
Percent of Participants With Major Hematological Response (MaHR) With 2 Years of Follow-up From Date of Last Enrollment - Randomized Population
Timepoint [1] 0 0
Randomization up to 2 years
Secondary outcome [2] 0 0
Percent of Participants With Major Hematologic Response (MaHR) by Disease Group - Randomized Population
Timepoint [2] 0 0
Randomization up to 2 years
Secondary outcome [3] 0 0
Median Time to Major Hematologic Response (MaHR) - Randomized Population
Timepoint [3] 0 0
Day 1 up to 6 months (time of primary endpoint), 2 years
Secondary outcome [4] 0 0
Median Duration of a Major Hematologic Response (MaHR) in Those Participants Who Achieved a MaHR During the Study
Timepoint [4] 0 0
Day 1 up to 5 years
Secondary outcome [5] 0 0
Percent of Participants With Overall Hematologic Response - Randomized Population
Timepoint [5] 0 0
Randomization up to 6 Months, 2 Years
Secondary outcome [6] 0 0
Number of Participants With Best Confirmed Hematologic Response, Major Hematologic Response (MaHR) and Overall Hematologic Response - Randomized Population
Timepoint [6] 0 0
Randomization up to 6 months, 2 years
Secondary outcome [7] 0 0
Percent of Participants With Major Cytogenetic Response (MCyR) - Randomized Population
Timepoint [7] 0 0
Randomization up to 6 Months, 2 Years
Secondary outcome [8] 0 0
Number of Participants With Best Cytogenic Response (CyR) - Randomized Population
Timepoint [8] 0 0
Randomization up to 6 Months, 2 Years
Secondary outcome [9] 0 0
Median Progression Free Survival (PFS) - Randomized Population
Timepoint [9] 0 0
Randomization up to 5 Years
Secondary outcome [10] 0 0
Median Overall Survival (OS) - Randomized Population
Timepoint [10] 0 0
Randomization up to 5 Years
Secondary outcome [11] 0 0
Progression Free Survival (PFS) and Overall Survival (OS) at 24, 36, 48, and 60 Months - Randomized Population
Timepoint [11] 0 0
24 months, 36 months, 48 months, 60 months
Secondary outcome [12] 0 0
Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation and Drug-related Fluid Retention AEs, up to Year 7 in Treated Participants
Timepoint [12] 0 0
Day 1 to Year 7
Secondary outcome [13] 0 0
Number of Participants With Normal Baseline Versus Worst Grade 3/4 Hematology Laboratory Abnormalities up to Year 2 in Treated Participants
Timepoint [13] 0 0
Baseline to Year 2
Secondary outcome [14] 0 0
Number of Participants With Grade 4 Myelosuppression Determined From Hematology Evaluations
Timepoint [14] 0 0
Day 1 up to Year 7
Secondary outcome [15] 0 0
Number of Participants With Normal Baseline Versus Worst Grade 3/4 Biochemistry Laboratory Abnormalities up to Year 2 in Treated Participants
Timepoint [15] 0 0
Baseline to Year 2
Secondary outcome [16] 0 0
Number of Participants With Changes From Baseline in QT Interval Corrected With Fridericia Formula (QTcF) up to Year 2 in Treated Participants
Timepoint [16] 0 0
Baseline to Year 2
Secondary outcome [17] 0 0
Number of Participants With Maximal QTcF Intervals up to Year 2 in Treated Participants
Timepoint [17] 0 0
Baseline up to Year 2

Eligibility
Key inclusion criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.



* Patients with Philadelphia-Positive (Ph+) (or BCR/ABL+) accelerated phase chronic myeloid leukemia, Ph+ (or BCR/ABL+) blast phase chronic myeloid leukemia, or Ph+ (or BCR/ABL+) acute lymphoblastic leukemia whose disease has primary or acquired hematologic resistance to imatinib mesylate or who are intolerant of imatinib mesylate
* Men and women, 18 years of age or older
* Adequate hepatic function
* Adequate renal function
* Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for a period of at least 1 month before and at least 3 months after the study in such a manner that the risk of pregnancy is minimized
* Eastern Cooperative Oncology Group (ECOG) performance status score 0 - 2
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Women who are pregnant or breastfeeding
* A serious uncontrolled medical disorder or active infection that would impair the ability of the subject to receive protocol therapy
* Uncontrolled or significant cardiovascular disease
* Medications that increase bleeding risk
* Medications that change heart rhythms
* Dementia or altered mental status that would prohibit the understanding or rendering of informed consent
* History of significant bleeding disorder unrelated to CML
* Concurrent incurable malignancy other than CML
* Evidence of organ dysfunction or digestive dysfunction that would prevent administration of study therapy
* Prior therapy with BMS-35425
* Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2013
Sample size
Target
Accrual to date
Final
638
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Local Institution - St Leonards
Recruitment hospital [2] 0 0
Local Institution - South Brisbane
Recruitment hospital [3] 0 0
Local Institution - Adelaide
Recruitment hospital [4] 0 0
Local Institution - Parkville
Recruitment hospital [5] 0 0
Local Institution - Perth
Recruitment postcode(s) [1] 0 0
2065 - St Leonards
Recruitment postcode(s) [2] 0 0
4101 - South Brisbane
Recruitment postcode(s) [3] 0 0
SA 5000 - Adelaide
Recruitment postcode(s) [4] 0 0
3050 - Parkville
Recruitment postcode(s) [5] 0 0
WA 6000 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
State/province [2] 0 0
California
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United States of America
State/province [3] 0 0
District of Columbia
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United States of America
State/province [4] 0 0
Florida
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United States of America
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Georgia
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United States of America
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Illinois
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United States of America
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Indiana
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United States of America
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Kentucky
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United States of America
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Maryland
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United States of America
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Massachusetts
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Michigan
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Missouri
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Nebraska
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New Jersey
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New York
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State/province [16] 0 0
North Carolina
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Ohio
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Oregon
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Pennsylvania
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Tennessee
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Texas
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Washington
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Argentina
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Buenos Aires
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Wien
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B-leuven
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Belgium
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Brugge
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Belgium
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Bruxelles
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Belgium
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Charleroi
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Yvoir
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Brazil
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Parana
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Brazil
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Sao Paulo
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Brazil
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Rio De Janeiro
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Canada
State/province [33] 0 0
Alberta
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British Columbia
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Quebec
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Czech Republic
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Brno
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Czech Republic
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Prague 2
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Aarhus C
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Herlev
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Odense C
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Finland
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Helsinki
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Caen Cedex
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France
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Creteil Cedex
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France
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Grenoble Cedex 9
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France
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Lille Cedex
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Lyon Cedex
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France
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Marseille Cedex 9
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France
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Nantes
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France
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Paris Cedex 10
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France
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Pessac
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France
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Poitiers Cedex
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France
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Strasbourg Cedex
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Germany
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Dresden
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Germany
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Frankfurt
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Hamburg
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Germany
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Leipzig
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Germany
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Mainz
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Germany
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Mannheim
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Greece
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Athens
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Dublin
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Israel
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Ramat-gan
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Bari
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Bologna
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Monza
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Napoli
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Italy
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Roma
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Korea, Republic of
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Jeollanam-do
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Seoul
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Rotterdam
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Lodz
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Free State
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Gauteng
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South Africa
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Western Cape
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Valencia
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Sweden
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Lund
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Sweden
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Stockholm
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Sweden
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Umea
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Sweden
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Uppsala
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Switzerland
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Basel
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Taiwan
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Taipei
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Taiwan
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Taoyuan
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Thailand
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Bangkok
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United Kingdom
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Greater London
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United Kingdom
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Scotland
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United Kingdom
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Tyne And Wear
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Edinburgh
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United Kingdom
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Liverpool

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a phase III study of BMS-354825 in subjects with chronic myelogenous leukemia in accelerated phase, or in myeloid or lymphoid blast phase or with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia who are resistant or intolerant to imatinib mesylate (Gleevec).
Trial website
https://clinicaltrials.gov/study/NCT00123487
Trial related presentations / publications
Chu SC, Tang JL, Li CC. Dasatinib in chronic myelogenous leukemia. N Engl J Med. 2006 Sep 7;355(10):1062-3; author reply 1063-4. No abstract available.
Lilly MB, Ottmann OG, Shah NP, Larson RA, Reiffers JJ, Ehninger G, Muller MC, Charbonnier A, Bullorsky E, Dombret H, Brigid Bradley-Garelik M, Zhu C, Martinelli G. Dasatinib 140 mg once daily versus 70 mg twice daily in patients with Ph-positive acute lymphoblastic leukemia who failed imatinib: Results from a phase 3 study. Am J Hematol. 2010 Mar;85(3):164-70. doi: 10.1002/ajh.21615.
Kantarjian H, Cortes J, Kim DW, Dorlhiac-Llacer P, Pasquini R, DiPersio J, Muller MC, Radich JP, Khoury HJ, Khoroshko N, Bradley-Garelik MB, Zhu C, Tallman MS. Phase 3 study of dasatinib 140 mg once daily versus 70 mg twice daily in patients with chronic myeloid leukemia in accelerated phase resistant or intolerant to imatinib: 15-month median follow-up. Blood. 2009 Jun 18;113(25):6322-9. doi: 10.1182/blood-2008-11-186817. Epub 2009 Apr 15.
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00123487