Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Imatinib-Intolerant	Imatinib intolerance was defined as: a) Grade 3 or greater non-hematologic toxicity that is imatinib-related b) Grade 4 hematologic toxicity that is imatinib-related lasting more than 7 days.
Imatinib-Resistant	Imatinib resistance, acquired or primary. Acquired resistance: subjects who achieved major cytogenetic response (MCyR) or complete hematologic response (CHR) on imatinib at any dose prior to progression, defined by 1 of the following: a) loss of MCyR, b) loss of CHR, c) increasing white blood cell (WBC) count. Primary resistance: subjects who never achieved MCyR or CHR at any dose, and met 1 of the following: a) continuously increasing WBC count on at least 2 consecutive evaluations at least 2 weeks apart with the final assessment showing a doubling of WBC from the nadir to ≥20,000/mm3 or an absolute increase in WBC by more than 50,000/mm3 above lowest count after starting imatinib, b) no CHR after 3 months, c) no cytogenetic response (CyR) after 6 months d) no MCyR after 12 months. Resistance was also defined as chronic myeloid leukemia (CML) with resistance to imatinib ≤600mg/d with genetic mutation in BCR-ABL gene (L248V, G250E, Q252H/R, Y253H/F, E255K/V, T315I/D, F317L, H369P/R).

Participant Flow:   Overall Study

	Imatinib-Intolerant	Imatinib-Resistant
STARTED	99	288
COMPLETED	99	288
NOT COMPLETED	0	0

Reporting Groups

	Description
Imatinib-Intolerant	Imatinib intolerance was defined as: a) Grade 3 or greater non-hematologic toxicity that is imatinib-related b) Grade 4 hematologic toxicity that is imatinib-related lasting more than 7 days.
Imatinib-Resistant	Imatinib resistance, acquired or primary. Acquired resistance: subjects who achieved major cytogenetic response (MCyR) or complete hematologic response (CHR) on imatinib at any dose prior to progression, defined by 1 of the following: a) loss of MCyR, b) loss of CHR, c) increasing white blood cell (WBC) count. Primary resistance: subjects who never achieved MCyR or CHR at any dose, and met 1 of the following: a) continuously increasing WBC count on at least 2 consecutive evaluations at least 2 weeks apart with the final assessment showing a doubling of WBC from the nadir to ≥20,000/mm3 or an absolute increase in WBC by more than 50,000/mm3 above lowest count after starting imatinib, b) no CHR after 3 months, c) no cytogenetic response (CyR) after 6 months d) no MCyR after 12 months. Resistance was also defined as chronic myeloid leukemia (CML) with resistance to imatinib ≤600mg/d with genetic mutation in BCR-ABL gene (L248V, G250E, Q252H/R, Y253H/F, E255K/V, T315I/D, F317L, H369P/R).

Baseline Measures

	Imatinib-Intolerant	Imatinib-Resistant	Total
Number of Participants   [units: participants]	99	288	387
Age, Customized   [units: participants]
Between 21 and 45 years	25	78	103
Between 46 and 65 years	55	131	186
Between 66 and 75 years	17	65	82
> 75 years	2	14	16
Age   [units: years] Mean ± Standard Deviation	54.6  ± 12.5	55.7  ± 13.5	55.4  ± 13.3
Gender   [units: participants]
Female	57	139	196
Male	42	149	191
Race/Ethnicity, Customized   [units: participants]
White	93	252	345
Black/African American	2	13	15
Asian	3	10	13
Other	1	12	13
Not Reported	0	1	1
Performance Status - Eastern Cooperative Oncology Group Scale (ECOG) [1] [units: participants]
Score = 0 (Fully active)	71	205	276
Score=1 (physically strenuous activity restricted)	28	77	105
Score=2 capable of all selfcare, unable to work	0	3	3
Score=3 limited selfcare, bed/chair confined >50%	0	0	0
Score=4 Completely disabled, bed/chair confined	0	0	0
Score=5 Dead	0	0	0
Not Reported	0	3	3
Functional Assessment of Cancer Therapy-General (FACT-G) [2] [units: units on a scale] Mean ± Standard Deviation
Total FACT-G	81.1  ± 14.4	82.4  ± 13.1	82.1  ± 13.4
Physical Well Being (PWB)	22.0  ± 5.1	21.6  ± 5.2	21.7  ± 5.2
Social/Family Well-Being (SWB)	23.0  ± 4.4	23.0  ± 4.5	23.0  ± 4.4
Emotional Well-Being (EWB)	17.3  ± 4.0	18.4  ± 3.7	18.1  ± 3.8
Functional Well-Being (FWB)	18.7  ± 5.5	19.6  ± 5.6	19.4  ± 5.6

1.  Primary:

Number of Imatinib-Resistant Participants With Major Cytogenetic Response (MCyR)   [ Time Frame: 2 years ]

2.  Secondary:

Number of Imatinib Intolerant Participants With Major Cytogenetic Response (MCyR)   [ Time Frame: 2 years ]

3.  Secondary:

Percentage of Participants Who Achieved MCyR and Did Not Progress at 12 Months and 24 Months   [ Time Frame: 12 Months, 24 Months ]

4.  Secondary:

Time From First Dosing Date to Date of MCyR   [ Time Frame: Baseline (within 4 weeks of Day 1), every 12 weeks ]

5.  Secondary:

Number of Participants With Complete Hematologic Response (CHR)   [ Time Frame: Baseline (within 72 hours of start of therapy), weekly until Week 12, every 3 months until off-study ]

6.  Secondary:

Percentage of Participants Who Acheived CHR and Did Not Progress at 12 Months and 24 Months   [ Time Frame: 12 Months, 24 Months ]

7.  Secondary:

Time in Months From First Dosing Until Date of CHR   [ Time Frame: Baseline (within 72 hours of start of therapy), weekly until Week 12, every 3 months until off-study ]

8.  Secondary:

Major Molecular Response (MMR)   [ Time Frame: 2 years ]

9.  Secondary:

Functional Assessment of Cancer Therapy-General (FACT-G) Questionnaire Minimal Clinically Significant Change From Baseline   [ Time Frame: Baseline, Day 29, every 4 weeks for the first 24 weeks, then every 12 weeks for the remainder of treatment, after end of treatment. Treatment continued until disease progression or development of toxicity or until other protocol-defined criteria. ]

10.  Secondary:

Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to AEs   [ Time Frame: Continuously, from baseline through 2 years ]

11.  Secondary:

Blood Sample Collection for Pharmacokinetic (PK) Analysis of Dasatinib   [ Time Frame: Day 8 of study; pretreatment through sample between 30 minutes and 3 hours following treatment, a sample between 5 hours and 8 hours following treatment and a sample at 12 hours, prior to the next dose. ]