Trial Review

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00123474




Registration number
NCT00123474
Ethics application status
Date submitted
21/07/2005
Date registered
25/07/2005
Date last updated
25/08/2016

Titles & IDs
Public title
Chronic Myelogenous Leukemia (CML) - Follow on: Study of BMS-354825 in Subjects With CML
Scientific title
A Randomized Two-by-Two, Multicenter, Open-Label Phase III Study of BMS-354825 Administered Orally at a Dose of 50 mg or 70 mg Twice Daily or 100 mg or 140 mg Once Daily in Subjects With Chronic Phase Philadelphia Chromosome or BCR-ABL Positive Chronic Myelogenous Leukemia Who Are Resistant or Intolerant to Imatinib Mesylate (Gleevec)
Secondary ID [1] 0 0
CA180-034
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myeloid Leukemia, Chronic, Chronic-Phase 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

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

Experimental: 1 -

Experimental: 2 -

Experimental: 3 -

Experimental: 4 -


Treatment: Drugs: dasatinib
Tablets, Oral, 50 mg BID, indefinitely, survival study

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

Treatment: Drugs: dasatinib
Tablets, Oral, 100 mg QD, 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 Cytogenetic Response (MCyR) at 6 Months Follow-Up
Timepoint [1] 0 0
6 months
Secondary outcome [1] 0 0
Percent of Participants With MCyR At or Prior to 24 Months Follow-Up
Timepoint [1] 0 0
24 months
Secondary outcome [2] 0 0
Percent of Participants With Complete Hematologic Response (CHR) at 6 and 24 Months Follow-Up
Timepoint [2] 0 0
6 months, 24 months
Secondary outcome [3] 0 0
Time to MCyR in Participants With MCyR at 6 Months Follow-Up
Timepoint [3] 0 0
6 months
Secondary outcome [4] 0 0
Time to CHR in Participants With CHR at 6 Months Follow-Up
Timepoint [4] 0 0
6 months
Secondary outcome [5] 0 0
Time to MCyR in Participants With MCyR at 24 Months Follow-Up
Timepoint [5] 0 0
24 months
Secondary outcome [6] 0 0
Time to CHR in Participants With CHR At 24 Months Follow-Up
Timepoint [6] 0 0
24 months
Secondary outcome [7] 0 0
Number of Participants With MCyR Whose Disease Progressed by 24 Months
Timepoint [7] 0 0
24 months
Secondary outcome [8] 0 0
Number of Participants With CHR Whose Disease Progressed by 24 Months
Timepoint [8] 0 0
24 months
Secondary outcome [9] 0 0
Number of Participants With MCyR and Baseline BCR-ABL Gene Mutation - All Treated Participants
Timepoint [9] 0 0
Baseline up to 24 months
Secondary outcome [10] 0 0
Percent of Imatinib-Resistant Participants With Progression Free Survival (PFS) at 24, 36, 48, 60, 72, and 84 Months Follow-Up
Timepoint [10] 0 0
24, 36, 48, 60, 72, and 84 months
Secondary outcome [11] 0 0
Percent of Imatinib-Resistant Participants With Overall Survival (OS) at 24, 36, 48, 60, 72, and 84 Months Follow-Up
Timepoint [11] 0 0
24, 36, 48, 60, 72, and 84 months
Secondary outcome [12] 0 0
Percent of Participants Intolerant to Imatinib With MCyR at 6 Months and at 24 Months Follow-Up, by QD and BID Schedules and by Total Daily Dose
Timepoint [12] 0 0
6 months, 24 months
Secondary outcome [13] 0 0
Percent of Participants Intolerant to Imatinib With CHR at 6 Months and at 24 Months Follow-Up
Timepoint [13] 0 0
6 months, 24 months
Secondary outcome [14] 0 0
Percent of Imatinib Intolerant Participants With Progression Free Survival After 24, 36, 48, 60, 72, and 84 Months of Follow-Up
Timepoint [14] 0 0
24, 36, 48, 60, 72, and 84 months
Secondary outcome [15] 0 0
Percent of Imatinib Intolerant Participants With Overall Survival After 24, 36, 48, 60, 72, and 84 Months of Follow-up
Timepoint [15] 0 0
24, 36, 48, 60, 72, and 84 months
Secondary outcome [16] 0 0
Percent of All Randomized Participants With Cytogenic and Hematologic Response by Dosing Schedule (QD or BID) and by Total Daily Dose (100 mg or 140 mg) at 6 Months Follow-Up
Timepoint [16] 0 0
6 months
Secondary outcome [17] 0 0
Percent of All Randomized Participants With Cytogenic and Hematologic Response by Dosing Schedule (QD or BID) and by Total Daily Dose (100 mg or 140 mg) at 24 Months Follow-Up
Timepoint [17] 0 0
24 months
Secondary outcome [18] 0 0
Percent of Participants With Progression Free Survival (PFS) at 24, 36, 48, 60, 72, and 84 Months Follow-Up by Dose Schedule and Total Daily Dose - All Randomized Participants
Timepoint [18] 0 0
24, 36, 48, 60, 72, and 84 months
Secondary outcome [19] 0 0
Percent of Participants Overall Survival at 24, 36, 48, 60, 72, and 84 Months Follow-Up - All Randomized Participants
Timepoint [19] 0 0
24, 36, 48, 60, 72, and 84 months
Secondary outcome [20] 0 0
Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) That Led to Treatment Discontinuation at 24 Months of Follow-up
Timepoint [20] 0 0
Baseline to 30 days post last dose, up to 24 months
Secondary outcome [21] 0 0
Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) That Led toTreatment Discontinuation After 7 Year Follow-up
Timepoint [21] 0 0
Baseline to 30 days post last dose, up to 7 years (study closure July 2014)

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



* Subjects with Philadelphia chromosome positive (Ph+) (or BCR/ABL+) chronic phase chronic myeloid leukemia whose disease has primary or acquired hematologic resistance to imatinib mesylate or who are intolerant of imatinib mesylate.
* Men and women, 18 years 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.
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Women who are pregnant or breastfeeding
* Subjects who are eligible and willing to undergo transplantation during the screening period
* 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
* 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
1/07/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2014
Sample size
Target
Accrual to date
Final
724
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Local Institution - Camperdown
Recruitment hospital [2] 0 0
Local Institution - St Leonards
Recruitment hospital [3] 0 0
Local Institution - South Brisbane
Recruitment hospital [4] 0 0
Local Institution - Adelaide
Recruitment hospital [5] 0 0
Local Institution - East Melbourne
Recruitment hospital [6] 0 0
Local Institution - Perth
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2065 - St Leonards
Recruitment postcode(s) [3] 0 0
4101 - South Brisbane
Recruitment postcode(s) [4] 0 0
SA 5000 - Adelaide
Recruitment postcode(s) [5] 0 0
3002 - East Melbourne
Recruitment postcode(s) [6] 0 0
WA 6000 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
District of Columbia
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Indiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Kansas
Country [9] 0 0
United States of America
State/province [9] 0 0
Kentucky
Country [10] 0 0
United States of America
State/province [10] 0 0
Maryland
Country [11] 0 0
United States of America
State/province [11] 0 0
Massachusetts
Country [12] 0 0
United States of America
State/province [12] 0 0
Michigan
Country [13] 0 0
United States of America
State/province [13] 0 0
Missouri
Country [14] 0 0
United States of America
State/province [14] 0 0
Nebraska
Country [15] 0 0
United States of America
State/province [15] 0 0
Nevada
Country [16] 0 0
United States of America
State/province [16] 0 0
New Jersey
Country [17] 0 0
United States of America
State/province [17] 0 0
New York
Country [18] 0 0
United States of America
State/province [18] 0 0
North Carolina
Country [19] 0 0
United States of America
State/province [19] 0 0
Ohio
Country [20] 0 0
United States of America
State/province [20] 0 0
Oregon
Country [21] 0 0
United States of America
State/province [21] 0 0
Pennsylvania
Country [22] 0 0
United States of America
State/province [22] 0 0
Tennessee
Country [23] 0 0
United States of America
State/province [23] 0 0
Texas
Country [24] 0 0
United States of America
State/province [24] 0 0
Washington
Country [25] 0 0
Argentina
State/province [25] 0 0
Buenos Aires
Country [26] 0 0
Argentina
State/province [26] 0 0
Capital Federal
Country [27] 0 0
Argentina
State/province [27] 0 0
Cordoba
Country [28] 0 0
Austria
State/province [28] 0 0
Wien
Country [29] 0 0
Belgium
State/province [29] 0 0
B-leuven
Country [30] 0 0
Belgium
State/province [30] 0 0
Brugge
Country [31] 0 0
Belgium
State/province [31] 0 0
Bruxelles
Country [32] 0 0
Belgium
State/province [32] 0 0
Charleroi
Country [33] 0 0
Belgium
State/province [33] 0 0
Edegem
Country [34] 0 0
Belgium
State/province [34] 0 0
Yvoir
Country [35] 0 0
Brazil
State/province [35] 0 0
Parana
Country [36] 0 0
Brazil
State/province [36] 0 0
CEP - Campinas
Country [37] 0 0
Brazil
State/province [37] 0 0
Rio de Janeiro
Country [38] 0 0
Brazil
State/province [38] 0 0
San Paulo, Sp
Country [39] 0 0
Brazil
State/province [39] 0 0
Sao Paulo
Country [40] 0 0
Canada
State/province [40] 0 0
Alberta
Country [41] 0 0
Canada
State/province [41] 0 0
Ontario
Country [42] 0 0
Canada
State/province [42] 0 0
Quebec
Country [43] 0 0
Czech Republic
State/province [43] 0 0
Brno
Country [44] 0 0
Czech Republic
State/province [44] 0 0
Prague 2
Country [45] 0 0
Denmark
State/province [45] 0 0
Aarhus C
Country [46] 0 0
Denmark
State/province [46] 0 0
Herlev
Country [47] 0 0
Denmark
State/province [47] 0 0
Odense C
Country [48] 0 0
Finland
State/province [48] 0 0
Helsinki
Country [49] 0 0
France
State/province [49] 0 0
Pierre Benite
Country [50] 0 0
France
State/province [50] 0 0
Caen
Country [51] 0 0
France
State/province [51] 0 0
Creteil Cedex
Country [52] 0 0
France
State/province [52] 0 0
Grenoble Cedex 09
Country [53] 0 0
France
State/province [53] 0 0
Lille Cedex
Country [54] 0 0
France
State/province [54] 0 0
Marseille Cedex 9
Country [55] 0 0
France
State/province [55] 0 0
Nantes
Country [56] 0 0
France
State/province [56] 0 0
Paris Cedex 10
Country [57] 0 0
France
State/province [57] 0 0
Poitiers Cedex
Country [58] 0 0
France
State/province [58] 0 0
Strasbourg
Country [59] 0 0
France
State/province [59] 0 0
Toulouse Cedex 9
Country [60] 0 0
Germany
State/province [60] 0 0
Dresden
Country [61] 0 0
Germany
State/province [61] 0 0
Frankfurt/main
Country [62] 0 0
Germany
State/province [62] 0 0
Hamburg
Country [63] 0 0
Germany
State/province [63] 0 0
Leipzig
Country [64] 0 0
Germany
State/province [64] 0 0
Mainz
Country [65] 0 0
Germany
State/province [65] 0 0
Mannheim
Country [66] 0 0
Hungary
State/province [66] 0 0
Budapest
Country [67] 0 0
Ireland
State/province [67] 0 0
Galway
Country [68] 0 0
Ireland
State/province [68] 0 0
Dublin
Country [69] 0 0
Israel
State/province [69] 0 0
Ramat-gan
Country [70] 0 0
Italy
State/province [70] 0 0
Bari
Country [71] 0 0
Italy
State/province [71] 0 0
Monza (mi)
Country [72] 0 0
Italy
State/province [72] 0 0
Napoli
Country [73] 0 0
Italy
State/province [73] 0 0
Orbassano
Country [74] 0 0
Italy
State/province [74] 0 0
Roma
Country [75] 0 0
Korea, Republic of
State/province [75] 0 0
Jeollanam-do
Country [76] 0 0
Korea, Republic of
State/province [76] 0 0
Kyunggi-do
Country [77] 0 0
Korea, Republic of
State/province [77] 0 0
Seoul
Country [78] 0 0
Mexico
State/province [78] 0 0
Distrito Federal
Country [79] 0 0
Netherlands
State/province [79] 0 0
Nijmegen
Country [80] 0 0
Netherlands
State/province [80] 0 0
Rotterdam
Country [81] 0 0
Norway
State/province [81] 0 0
Trondheim
Country [82] 0 0
Peru
State/province [82] 0 0
Lima
Country [83] 0 0
Philippines
State/province [83] 0 0
Quezon City
Country [84] 0 0
Poland
State/province [84] 0 0
Gdansk
Country [85] 0 0
Poland
State/province [85] 0 0
Katowice
Country [86] 0 0
Poland
State/province [86] 0 0
Krakow
Country [87] 0 0
Poland
State/province [87] 0 0
Lodz
Country [88] 0 0
Poland
State/province [88] 0 0
Lublin
Country [89] 0 0
Poland
State/province [89] 0 0
Warsaw
Country [90] 0 0
Russian Federation
State/province [90] 0 0
Moscow
Country [91] 0 0
Russian Federation
State/province [91] 0 0
St.petersburg
Country [92] 0 0
Singapore
State/province [92] 0 0
Singapore
Country [93] 0 0
South Africa
State/province [93] 0 0
Free State
Country [94] 0 0
South Africa
State/province [94] 0 0
Gauteng
Country [95] 0 0
South Africa
State/province [95] 0 0
Western Cape
Country [96] 0 0
Spain
State/province [96] 0 0
Madrid
Country [97] 0 0
Spain
State/province [97] 0 0
Pamplona
Country [98] 0 0
Sweden
State/province [98] 0 0
Lund
Country [99] 0 0
Sweden
State/province [99] 0 0
Uppsala
Country [100] 0 0
Switzerland
State/province [100] 0 0
Basel
Country [101] 0 0
Taiwan
State/province [101] 0 0
Taipei
Country [102] 0 0
Taiwan
State/province [102] 0 0
Taoyuan County
Country [103] 0 0
United Kingdom
State/province [103] 0 0
Cambridgeshire
Country [104] 0 0
United Kingdom
State/province [104] 0 0
Greater London
Country [105] 0 0
United Kingdom
State/province [105] 0 0
Merseyside
Country [106] 0 0
United Kingdom
State/province [106] 0 0
Tyne And Wear
Country [107] 0 0
United Kingdom
State/province [107] 0 0
West Midlands
Country [108] 0 0
United Kingdom
State/province [108] 0 0
Glasgow

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/NCT00123474