Trial Review

Technical difficulties have been reported by some users of the search function and is being investigated by technical staff. Thank you for your patience and apologies for any inconvenience caused.

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/ct2/show/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
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
Kentucky
Country [9] 0 0
United States of America
State/province [9] 0 0
Maryland
Country [10] 0 0
United States of America
State/province [10] 0 0
Massachusetts
Country [11] 0 0
United States of America
State/province [11] 0 0
Michigan
Country [12] 0 0
United States of America
State/province [12] 0 0
Missouri
Country [13] 0 0
United States of America
State/province [13] 0 0
Nebraska
Country [14] 0 0
United States of America
State/province [14] 0 0
New Jersey
Country [15] 0 0
United States of America
State/province [15] 0 0
New York
Country [16] 0 0
United States of America
State/province [16] 0 0
North Carolina
Country [17] 0 0
United States of America
State/province [17] 0 0
Ohio
Country [18] 0 0
United States of America
State/province [18] 0 0
Oregon
Country [19] 0 0
United States of America
State/province [19] 0 0
Pennsylvania
Country [20] 0 0
United States of America
State/province [20] 0 0
Tennessee
Country [21] 0 0
United States of America
State/province [21] 0 0
Texas
Country [22] 0 0
United States of America
State/province [22] 0 0
Washington
Country [23] 0 0
Argentina
State/province [23] 0 0
Buenos Aires
Country [24] 0 0
Austria
State/province [24] 0 0
Wien
Country [25] 0 0
Belgium
State/province [25] 0 0
B-leuven
Country [26] 0 0
Belgium
State/province [26] 0 0
Brugge
Country [27] 0 0
Belgium
State/province [27] 0 0
Bruxelles
Country [28] 0 0
Belgium
State/province [28] 0 0
Charleroi
Country [29] 0 0
Belgium
State/province [29] 0 0
Yvoir
Country [30] 0 0
Brazil
State/province [30] 0 0
Parana
Country [31] 0 0
Brazil
State/province [31] 0 0
Sao Paulo
Country [32] 0 0
Brazil
State/province [32] 0 0
Rio De Janeiro
Country [33] 0 0
Canada
State/province [33] 0 0
Alberta
Country [34] 0 0
Canada
State/province [34] 0 0
British Columbia
Country [35] 0 0
Canada
State/province [35] 0 0
Quebec
Country [36] 0 0
Czech Republic
State/province [36] 0 0
Brno
Country [37] 0 0
Czech Republic
State/province [37] 0 0
Prague 2
Country [38] 0 0
Denmark
State/province [38] 0 0
Aarhus C
Country [39] 0 0
Denmark
State/province [39] 0 0
Herlev
Country [40] 0 0
Denmark
State/province [40] 0 0
Odense C
Country [41] 0 0
Finland
State/province [41] 0 0
Helsinki
Country [42] 0 0
France
State/province [42] 0 0
Caen Cedex
Country [43] 0 0
France
State/province [43] 0 0
Creteil Cedex
Country [44] 0 0
France
State/province [44] 0 0
Grenoble Cedex 9
Country [45] 0 0
France
State/province [45] 0 0
Lille Cedex
Country [46] 0 0
France
State/province [46] 0 0
Lyon Cedex
Country [47] 0 0
France
State/province [47] 0 0
Marseille Cedex 9
Country [48] 0 0
France
State/province [48] 0 0
Nantes
Country [49] 0 0
France
State/province [49] 0 0
Paris Cedex 10
Country [50] 0 0
France
State/province [50] 0 0
Pessac
Country [51] 0 0
France
State/province [51] 0 0
Poitiers Cedex
Country [52] 0 0
France
State/province [52] 0 0
Strasbourg Cedex
Country [53] 0 0
Germany
State/province [53] 0 0
Dresden
Country [54] 0 0
Germany
State/province [54] 0 0
Frankfurt
Country [55] 0 0
Germany
State/province [55] 0 0
Hamburg
Country [56] 0 0
Germany
State/province [56] 0 0
Leipzig
Country [57] 0 0
Germany
State/province [57] 0 0
Mainz
Country [58] 0 0
Germany
State/province [58] 0 0
Mannheim
Country [59] 0 0
Greece
State/province [59] 0 0
Athens
Country [60] 0 0
Hungary
State/province [60] 0 0
Budapest
Country [61] 0 0
Ireland
State/province [61] 0 0
Dublin
Country [62] 0 0
Israel
State/province [62] 0 0
Ramat-gan
Country [63] 0 0
Italy
State/province [63] 0 0
Bari
Country [64] 0 0
Italy
State/province [64] 0 0
Bologna
Country [65] 0 0
Italy
State/province [65] 0 0
Monza
Country [66] 0 0
Italy
State/province [66] 0 0
Napoli
Country [67] 0 0
Italy
State/province [67] 0 0
Orbassano (to)
Country [68] 0 0
Italy
State/province [68] 0 0
Roma
Country [69] 0 0
Korea, Republic of
State/province [69] 0 0
Jeollanam-do
Country [70] 0 0
Korea, Republic of
State/province [70] 0 0
Seoul
Country [71] 0 0
Netherlands
State/province [71] 0 0
Rotterdam
Country [72] 0 0
Norway
State/province [72] 0 0
Trondheim
Country [73] 0 0
Peru
State/province [73] 0 0
Lima
Country [74] 0 0
Philippines
State/province [74] 0 0
Quezon City
Country [75] 0 0
Poland
State/province [75] 0 0
Gdansk
Country [76] 0 0
Poland
State/province [76] 0 0
Katowice
Country [77] 0 0
Poland
State/province [77] 0 0
Krakow
Country [78] 0 0
Poland
State/province [78] 0 0
Lodz
Country [79] 0 0
Poland
State/province [79] 0 0
Lublin
Country [80] 0 0
Poland
State/province [80] 0 0
Warsaw
Country [81] 0 0
Russian Federation
State/province [81] 0 0
Moscow
Country [82] 0 0
Russian Federation
State/province [82] 0 0
St.petersburg
Country [83] 0 0
Singapore
State/province [83] 0 0
Singapore
Country [84] 0 0
South Africa
State/province [84] 0 0
Free State
Country [85] 0 0
South Africa
State/province [85] 0 0
Gauteng
Country [86] 0 0
South Africa
State/province [86] 0 0
Western Cape
Country [87] 0 0
Spain
State/province [87] 0 0
Barcelona
Country [88] 0 0
Spain
State/province [88] 0 0
Madrid
Country [89] 0 0
Spain
State/province [89] 0 0
Valencia
Country [90] 0 0
Sweden
State/province [90] 0 0
Lund
Country [91] 0 0
Sweden
State/province [91] 0 0
Stockholm
Country [92] 0 0
Sweden
State/province [92] 0 0
Umea
Country [93] 0 0
Sweden
State/province [93] 0 0
Uppsala
Country [94] 0 0
Switzerland
State/province [94] 0 0
Basel
Country [95] 0 0
Taiwan
State/province [95] 0 0
Taipei
Country [96] 0 0
Taiwan
State/province [96] 0 0
Taoyuan
Country [97] 0 0
Thailand
State/province [97] 0 0
Bangkok
Country [98] 0 0
United Kingdom
State/province [98] 0 0
Greater London
Country [99] 0 0
United Kingdom
State/province [99] 0 0
Scotland
Country [100] 0 0
United Kingdom
State/province [100] 0 0
Tyne And Wear
Country [101] 0 0
United Kingdom
State/province [101] 0 0
Edinburgh
Country [102] 0 0
United Kingdom
State/province [102] 0 0
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/ct2/show/NCT00123487
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