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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
Secondary ID [1] 0 0
2006-005712-27
Secondary ID [2] 0 0
CA180-056
Universal Trial Number (UTN)
Trial acronym
DASISION
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myeloid Leukemia, Chronic 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
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Best Confirmed Complete Cytogenetic Response (cCCyR) Within 12 Months
Timepoint [1] 0 0
Pretreatment, every 3 months up to 12 months
Secondary outcome [1] 0 0
Percentage of Participants Remaining in Confirmed Complete Cytogenetic Response (cCCyR)
Timepoint [1] 0 0
Years 2, 3, 4 and 5
Secondary outcome [2] 0 0
Percentage of Participants With Major Molecular Response (MMR) at Any Time
Timepoint [2] 0 0
Planned total follow-up duration of 5 years
Secondary outcome [3] 0 0
Time to Confirmed Complete Cytogenic Response (cCCyR) Overall
Timepoint [3] 0 0
Day 1 to 5 years
Secondary outcome [4] 0 0
Time to Major Molecular Response (MMR) Overall
Timepoint [4] 0 0
Day 1 to 5 years
Secondary outcome [5] 0 0
Percentage of Participants With Progression-free Survival (PFS)
Timepoint [5] 0 0
Participants were followed-up for at least 5 years
Secondary outcome [6] 0 0
Percentage of Participants With Overall Survival (OS)
Timepoint [6] 0 0
Participants were followed-up for at least 5 years

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

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

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
1/09/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2015
Sample size
Target
Accrual to date
Final
547
Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA
Recruitment hospital [1] 0 0
Local Institution - Waratah
Recruitment hospital [2] 0 0
Local Institution - Brisbane
Recruitment hospital [3] 0 0
Local Institution - Greenslopes
Recruitment hospital [4] 0 0
Local Institution - Perth
Recruitment postcode(s) [1] 0 0
2298 - Waratah
Recruitment postcode(s) [2] 0 0
4029 - Brisbane
Recruitment postcode(s) [3] 0 0
4120 - Greenslopes
Recruitment postcode(s) [4] 0 0
WA 6000 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Oregon
Country [2] 0 0
Argentina
State/province [2] 0 0
Buenos Aires
Country [3] 0 0
Austria
State/province [3] 0 0
Innsbruck
Country [4] 0 0
Austria
State/province [4] 0 0
Wien
Country [5] 0 0
Belgium
State/province [5] 0 0
Brugge
Country [6] 0 0
Belgium
State/province [6] 0 0
Bruxelles
Country [7] 0 0
Brazil
State/province [7] 0 0
Parana
Country [8] 0 0
Brazil
State/province [8] 0 0
Sao Paulo
Country [9] 0 0
Brazil
State/province [9] 0 0
Rio De Janeiro
Country [10] 0 0
Chile
State/province [10] 0 0
Metropolitana
Country [11] 0 0
China
State/province [11] 0 0
Beijing
Country [12] 0 0
China
State/province [12] 0 0
Fujian
Country [13] 0 0
China
State/province [13] 0 0
Shanghai
Country [14] 0 0
China
State/province [14] 0 0
Tianjin
Country [15] 0 0
Colombia
State/province [15] 0 0
Bogota
Country [16] 0 0
Czech Republic
State/province [16] 0 0
Brno
Country [17] 0 0
Czech Republic
State/province [17] 0 0
Hradec Kralove
Country [18] 0 0
Czech Republic
State/province [18] 0 0
Olomouc
Country [19] 0 0
Czech Republic
State/province [19] 0 0
Prague 2
Country [20] 0 0
Denmark
State/province [20] 0 0
Aarhus
Country [21] 0 0
France
State/province [21] 0 0
Cedex 1
Country [22] 0 0
France
State/province [22] 0 0
Brest Cedex 02
Country [23] 0 0
France
State/province [23] 0 0
Lille Cedex
Country [24] 0 0
France
State/province [24] 0 0
Limoges
Country [25] 0 0
France
State/province [25] 0 0
Montpellier Cedex
Country [26] 0 0
France
State/province [26] 0 0
Paris Cedex 10
Country [27] 0 0
France
State/province [27] 0 0
Paris
Country [28] 0 0
France
State/province [28] 0 0
Pierre Benite Cedex
Country [29] 0 0
France
State/province [29] 0 0
Poitiers Cedex
Country [30] 0 0
France
State/province [30] 0 0
Rennes
Country [31] 0 0
France
State/province [31] 0 0
Strasbourg Cedex
Country [32] 0 0
France
State/province [32] 0 0
Toulouse Cedex 09
Country [33] 0 0
France
State/province [33] 0 0
Vandoeuvre Les Nancy
Country [34] 0 0
Germany
State/province [34] 0 0
Berlin
Country [35] 0 0
Germany
State/province [35] 0 0
Rostock
Country [36] 0 0
Germany
State/province [36] 0 0
Tuebingen
Country [37] 0 0
Germany
State/province [37] 0 0
Ulm
Country [38] 0 0
Greece
State/province [38] 0 0
Thessaloniki
Country [39] 0 0
Hungary
State/province [39] 0 0
Budapest
Country [40] 0 0
Hungary
State/province [40] 0 0
Debrecen
Country [41] 0 0
India
State/province [41] 0 0
Tamilnadu
Country [42] 0 0
India
State/province [42] 0 0
Ahmedabad
Country [43] 0 0
India
State/province [43] 0 0
Cochin
Country [44] 0 0
India
State/province [44] 0 0
Mumbai
Country [45] 0 0
India
State/province [45] 0 0
Trivandrum
Country [46] 0 0
Italy
State/province [46] 0 0
Bologna
Country [47] 0 0
Italy
State/province [47] 0 0
Catania
Country [48] 0 0
Italy
State/province [48] 0 0
Monza (mb)
Country [49] 0 0
Italy
State/province [49] 0 0
Orbassano (to)
Country [50] 0 0
Italy
State/province [50] 0 0
Pavia
Country [51] 0 0
Italy
State/province [51] 0 0
Roma
Country [52] 0 0
Japan
State/province [52] 0 0
Aichi
Country [53] 0 0
Japan
State/province [53] 0 0
Chiba
Country [54] 0 0
Japan
State/province [54] 0 0
Fukuoka
Country [55] 0 0
Japan
State/province [55] 0 0
Iwate
Country [56] 0 0
Japan
State/province [56] 0 0
Kagoshima
Country [57] 0 0
Japan
State/province [57] 0 0
Kanagawa
Country [58] 0 0
Japan
State/province [58] 0 0
Kyoto
Country [59] 0 0
Japan
State/province [59] 0 0
Miyagi
Country [60] 0 0
Japan
State/province [60] 0 0
Okayama
Country [61] 0 0
Japan
State/province [61] 0 0
Osaka
Country [62] 0 0
Japan
State/province [62] 0 0
Tokyo
Country [63] 0 0
Korea, Republic of
State/province [63] 0 0
Seoul
Country [64] 0 0
Mexico
State/province [64] 0 0
Distrito Federal
Country [65] 0 0
Mexico
State/province [65] 0 0
Nuevo Leon
Country [66] 0 0
Mexico
State/province [66] 0 0
Sinaloa
Country [67] 0 0
Netherlands
State/province [67] 0 0
Groningen
Country [68] 0 0
Netherlands
State/province [68] 0 0
Nijmegen
Country [69] 0 0
Peru
State/province [69] 0 0
Arequipa
Country [70] 0 0
Peru
State/province [70] 0 0
Lima
Country [71] 0 0
Poland
State/province [71] 0 0
Chorzow
Country [72] 0 0
Poland
State/province [72] 0 0
Krakow
Country [73] 0 0
Poland
State/province [73] 0 0
Lodz
Country [74] 0 0
Poland
State/province [74] 0 0
Poznan
Country [75] 0 0
Poland
State/province [75] 0 0
Warsaw
Country [76] 0 0
Russian Federation
State/province [76] 0 0
Moscow
Country [77] 0 0
Russian Federation
State/province [77] 0 0
Rostov-on-don
Country [78] 0 0
Russian Federation
State/province [78] 0 0
St.petersburg
Country [79] 0 0
Singapore
State/province [79] 0 0
Singapore
Country [80] 0 0
Spain
State/province [80] 0 0
A Coruna
Country [81] 0 0
Spain
State/province [81] 0 0
Barcelona
Country [82] 0 0
Spain
State/province [82] 0 0
Madrid
Country [83] 0 0
Spain
State/province [83] 0 0
Malaga
Country [84] 0 0
Spain
State/province [84] 0 0
Oviedo
Country [85] 0 0
Spain
State/province [85] 0 0
Salamanca
Country [86] 0 0
Spain
State/province [86] 0 0
Valencia
Country [87] 0 0
Turkey
State/province [87] 0 0
Ankara
Country [88] 0 0
Turkey
State/province [88] 0 0
Kayseri

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00481247