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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00481247
Registration number
NCT00481247
Ethics application status
Date submitted
30/05/2007
Date registered
1/06/2007
Date last updated
15/02/2017
Titles & IDs
Public title
A Phase III Study of Dasatinib vs Imatinib in Patients With Newly Diagnosed Chronic Phase Chronic Myeloid Leukemia
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Scientific title
An Open-Label, Randomized, Multicenter Phase III Trial of Dasatinib (SPRYCEL®) vs. Standard Dose Imatinib (400 mg) in the Treatment of Subjects With Newly Diagnosed Chronic Phase Philadelphia Chromosome Positive Chronic Myeloid Leukemia
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Secondary ID [1]
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2006-005712-27
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Secondary ID [2]
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CA180-056
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Universal Trial Number (UTN)
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Trial acronym
DASISION
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Myeloid Leukemia, Chronic
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0
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Condition category
Condition code
Cancer
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Leukaemia - Acute leukaemia
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Cancer
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0
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0
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Leukaemia - Chronic leukaemia
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Cancer
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0
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0
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Children's - Leukaemia & Lymphoma
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Human Genetics and Inherited Disorders
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0
0
0
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Other human genetics and inherited disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Dasatinib
Treatment: Drugs - Imatinib
Experimental: Dasatinib -
Active Comparator: Imatinib -
Treatment: Drugs: Dasatinib
Tablets, oral, dasatinib 50-140 mg once daily (QD)
Treatment: Drugs: Imatinib
Tablets, oral, imatinib 200-800 mg, QD
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants With Best Confirmed Complete Cytogenetic Response (cCCyR) Within 12 Months
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Assessment method [1]
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Cytogenetic response (CyR) is based on the prevalence of Philadelphia positive (Ph+) cells in metaphase from bone marrow (BM) sample. (Ideally, 25 metaphases but at least 20 metaphases from a BM sample were evaluated). Complete Cytogenetic Response (CCyR)=0% Ph+ cells in metaphase in BM. A cCCyR=those in which all measurements up to at least 28 days after the initial response show an equivalent or better CCyR.
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Timepoint [1]
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Pretreatment, every 3 months up to 12 months
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Secondary outcome [1]
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Percentage of Participants Remaining in Confirmed Complete Cytogenetic Response (cCCyR)
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Assessment method [1]
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Cytogenetic response (CyR) is based on the prevalence of Philadelphia positive (Ph+) cells in metaphase from bone marrow (BM) sample. (Ideally, 25 metaphases but at least 20 metaphases from a BM sample were evaluated). Complete Cytogenetic Response (CCyR)=0% Ph+ cells in metaphase in BM. A cCCyR=those in which all measurements up to at least 28 days after the initial response show an equivalent or better CCyR.
Percentage of participants in cCCyR at years 2, 3, 4 and 5 was computed for all randomized participants who achieved cCCyR as measured from the time of first confirmation until the date of progression or death. Participants with cCCyR who neither progress nor die are censored on the date of their last cytogenetic assessment. Participants without cCCyR are considered to have progressed on Day 1.
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Timepoint [1]
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Years 2, 3, 4 and 5
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Secondary outcome [2]
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Percentage of Participants With Major Molecular Response (MMR) at Any Time
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Assessment method [2]
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Molecular response was assessed using BCR-ABL transcript levels measured by realtime quantitative polymerase chain reaction. MMR is defined as a ratio BCR-ABL/ABL =0.1% on the international scale (ie, at least 3 log reduction from a standardized baseline value).
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Timepoint [2]
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Planned total follow-up duration of 5 years
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Secondary outcome [3]
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Time to Confirmed Complete Cytogenic Response (cCCyR) Overall
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Assessment method [3]
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The time to cCCyR for all randomized participants is defined as the time from the randomization date until criteria are first met for complete cytogenic response (provided it is confirmed later). The time to cCCyR analysis censors nonresponders who do not progress at their last cytogenetic assessments and nonresponders who progress at the maximum time of all randomized participants.
.
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Timepoint [3]
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Day 1 to 5 years
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Secondary outcome [4]
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Time to Major Molecular Response (MMR) Overall
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Assessment method [4]
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The time to MMR for all randomized participants is defined as the time from randomization date until measurement criteria are first met for MMR. The time to MMR analysis censors nonresponders who do not progress at their last molecular assessments and nonresponders who progress at the maximum time of all randomized participants.
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Timepoint [4]
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Day 1 to 5 years
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Secondary outcome [5]
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Percentage of Participants With Progression-free Survival (PFS)
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Assessment method [5]
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PFS was defined as the time from randomization until progression (any progression/death within 30 days of last dosing date, or between 30-60 days of last dosing prior to start of secondary therapy). Those who did not progress/die or who progressed/died after 60 days of last dose were censored at last on-study hematologic/cytogenetic assessment; those with progression/death 30-60 days of last dosing date and after start date of secondary therapy censored at last on-study hematologic/cytogenetic assessment prior to start of secondary therapy; those who had not received study treatment censored on date randomized.
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Timepoint [5]
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Participants were followed-up for at least 5 years
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Secondary outcome [6]
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Percentage of Participants With Overall Survival (OS)
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Assessment method [6]
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OS was defined as the time from randomization to the date of death. If the participant had not died, survival was censored on last date the participant was known to be alive.
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Timepoint [6]
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Participants were followed-up for at least 5 years
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Eligibility
Key inclusion criteria
Key
- Male or female, aged 18 years and older
- Chronic phase, Philadelphia Chromosome-positive chronic myeloid leukemia (CML)
- Eastern Cooperative Oncology Group Performance Status score of 0-2
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Minimum age
18
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Pleural Effusion
- Uncontrolled cardiovascular disease
- Significant bleeding disorder unrelated to CML
- Prior treatment with interferon/imatinib/dasatinib/anti-CML systemic treatments except
anagrelide/hydroxyurea
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/09/2007
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Date of last participant enrolment
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Actual
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Date of last data collection
Anticipated
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Actual
1/12/2015
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Sample size
Target
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Accrual to date
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Final
547
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA
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2298 - Waratah
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4029 - Brisbane
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4120 - Greenslopes
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Recruitment postcode(s) [4]
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WA 6000 - Perth
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Recruitment outside Australia
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Kayseri
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Bristol-Myers Squibb
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Ethics approval
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Summary
Brief summary
The purpose of this clinical research study is to compare the confirmed complete cytogenetic
response of dasatinib with that of imatinib within 12 months after randomization in patients
with newly diagnosed chronic-phase Philadelphia positive chronic myeloid leukemia. The safety
of this treatment will also be studied.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00481247
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Bristol-Myers Squibb
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Bristol-Myers Squibb
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00481247
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