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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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
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 - 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.
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) - 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.
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 - 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).
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 - 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.
.
Timepoint [3] 0 0
Day 1 to 5 years
Secondary outcome [4] 0 0
Time to Major Molecular Response (MMR) Overall - 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.
Timepoint [4] 0 0
Day 1 to 5 years
Secondary outcome [5] 0 0
Percentage of Participants With Progression-free Survival (PFS) - 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.
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) - 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.
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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
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.
Trial website
https://clinicaltrials.gov/show/NCT00481247
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

Summary results
Other publications