Chronic Myelogenous Leukemia or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemic Study

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
Chronic Myelogenous Leukemia (CML): QD Dosing at Study Entry	Participants with Chronic Myelogenous Leukemia (CML)were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). A total daily dose (TDD) of 50 mg, 75 mg, 105 mg, 140 mg or 180 mg dasatinib was taken once daily (QD). Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
CML: BID Dosing at Study Entry	Participants with CML were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). Treatment was received BID, with a TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg dasatinib. Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
Accelerated Phase CML: BID Dosing at Study Entry	Participants with accelerated phase CML were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). A TDD of 50 mg, 75 mg, 105 mg, 120 mg, 140 mg or 180 mg dasatinib was taken QD or split into 2 doses and taken BID (TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg). Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
Myeloid Blast Phase CML: BID Dosing at Study Entry	Participants with myeloid blast phase CML were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). A TDD of 50 mg, 75 mg, 105 mg, 120 mg, 140 mg or 180 mg dasatinib was taken QD or split into 2 doses and taken BID (TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg). Participants were dosed on 1 of 3 schedules: 5 days on, 2 days off; 6 days on, 1 day off; or continuous daily dosing and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.

Participant Flow:   Overall Study

	Chronic Myelogenous Leukemia (CML): QD Dosing at Study Entry	CML: BID Dosing at Study Entry	Accelerated Phase CML: BID Dosing at Study Entry	Myeloid Blast Phase CML: BID Dosing at Study Entry
STARTED	22	15	5	4
COMPLETED	0	0	0	0
NOT COMPLETED	22	15	5	4
Death	4	1	1	0
Lost to Follow-up	0	0	0	1
Adverse Event	5	2	0	0
Participant's request	1	0	0	0
Administrative reason	3	3	1	0
Deterioration without progression	0	1	0	0
Disease progression/relapse	5	4	2	2
Study closure	3	4	1	1
No response	1	0	0	0

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups

	Description
Chronic Myelogenous Leukemia (CML): QD Dosing at Study Entry	Participants with Chronic Myelogenous Leukemia (CML)were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). A total daily dose (TDD) of 50 mg, 75 mg, 105 mg, 140 mg or 180 mg dasatinib was taken once daily (QD). Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
CML: BID Dosing at Study Entry	Participants with CML were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). Treatment was received BID, with a TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg dasatinib. Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
Accelerated Phase CML: BID Dosing at Study Entry	Participants with accelerated phase CML were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). A TDD of 50 mg, 75 mg, 105 mg, 120 mg, 140 mg or 180 mg dasatinib was taken QD or split into 2 doses and taken BID (TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg). Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
Myeloid Blast Phase CML: BID Dosing at Study Entry	Participants with myeloid blast phase CML were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). A TDD of 50 mg, 75 mg, 105 mg, 120 mg, 140 mg or 180 mg dasatinib was taken QD or split into 2 doses and taken BID (TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg). Participants were dosed on 1 of 3 schedules: 5 days on, 2 days off; 6 days on, 1 day off; or continuous daily dosing and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
Total	Total of all reporting groups

Baseline Measures

	Chronic Myelogenous Leukemia (CML): QD Dosing at Study Entry	CML: BID Dosing at Study Entry	Accelerated Phase CML: BID Dosing at Study Entry	Myeloid Blast Phase CML: BID Dosing at Study Entry	Total
Overall Participants Analyzed  [Units: Participants]	22	15	5	4	46
Age  [Units: Years] Median (Full Range)	58   (41 to 81)	68   (30 to 80)	63   (51 to 74)	51   (34 to 62)	64   (30 to 81)
Age, Customized  [Units: Participants]
< 65 years	12	5	3	4	24
>= 65 years	10	10	2	0	22
Gender  [Units: Participants]
Female	11	7	4	1	23
Male	11	8	1	3	23
Race/Ethnicity, Customized  [Units: Participants]
Caucasian	18	11	3	3	35
Black/African American	2	3	1	0	6
Asian	0	1	0	0	1
Other races	2	0	1	1	4
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) [1]  [Units: Participants]
0 = fully active	18	13	3	4	38
1 = restricted physically strenuous activity	4	1	2	0	7
2 = ambulatory but unable to work	0	0	0	0	0
3 = capable of only limited self care	0	0	0	0	0
4 = completely disabled	0	0	0	0	0
5 = dead	0	0	0	0	0
Not reported	0	1	0	0	1
[1] The ECOG PS is used to assess disease severity, with 0 being the least severe score and 5 being the most severe score. A score of 0 is fully active; 1 is restricted physically strenuous activity; 2 is ambulatory but unable to work; 3 is capable of only limited self care; 4 is completely disabled; 5 is dead.

1.  Primary:

Number of Participants Who Died, Experienced Other Serious Adverse Events (SAEs), Adverse Events (AEs) and AEs Leading to Study Drug Discontinuation.   [ Time Frame: From start of study until up to 30 days after end of study participation. Median duration of exposure (on-study time) was 23.4 months. ]

2.  Primary:

Number of Participants Who Experienced Drug-related AEs and Drug-related SAEs.   [ Time Frame: From start of study until up to 30 days after end of study participation. Median duration of exposure (on-study time) was 23.4 months. ]

3.  Primary:

Number of Participants With Grade 3-4 Hematology Abnormalities   [ Time Frame: From start of study until up to 30 days after end of study participation. Median duration of exposure (on-study time) was 23.4 months. ]

4.  Primary:

Number of Participants With Grade 3-4 Serum Chemistry Abnormalities   [ Time Frame: From start of study until up to 30 days after end of study participation. Median duration of exposure (on-study time) was 23.4 months. ]

5.  Primary:

Number of Participants With Dose Interruptions and Dose Reductions   [ Time Frame: From start of study to final assessment (up to 32.2 months). ]

6.  Secondary:

Number of Participants With Complete Hematologic Response (CHR)   [ Time Frame: Pre-treatment to study discontinuation. Median duration of exposure (on-study time) was 23.4 months. ]

7.  Secondary:

Median Number of Months of CHR (Kaplan Meier Method)   [ Time Frame: Pre-treatment to study discontinuation. Median duration of exposure (on-study time) was 23.4 months. ]

8.  Secondary:

Number of Participants With Major Cytogenetic Response (MCyR)   [ Time Frame: Pre-treatment to study discontinuation. Median duration of exposure (on-study time) was 23.4 months. ]

9.  Secondary:

Median Number of Months of Major Cytogenetic Response (MCyR)   [ Time Frame: Pre-treatment to study discontinuation. Median duration of exposure (on-study time) was 23.4 months. ]

10.  Secondary:

Number of Participants With Best Cytogenetic Response   [ Time Frame: Pre-treatment to study discontinuation. Median duration of exposure (on-study time) was 23.4 months. ]

11.  Secondary:

Median Number of Months of Progression-free Survival (PFS) (Kaplan Meier Method)   [ Time Frame: Baseline to study discontinuation. Median duration of exposure (on-study time) was 23.4 months. ]

12.  Secondary:

Median Number of Months of Overall Survival (OS) (Kaplan Meier Method)   [ Time Frame: Baseline to study discontinuation. Median duration of exposure (on-study time) was 23.4 months. ]

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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