Chronic Myelogenous Leukemia or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemic Study

This study has been completed.

Sponsor:

Information provided by:

Bristol-Myers Squibb

ClinicalTrials.gov Identifier:

NCT00978731

First received: September 16, 2009

Last updated: April 25, 2011

Last verified: April 2011

History of Changes

Results First Received: November 23, 2010

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Leukemia
Intervention:	Drug: Dasatinib

Participant Flow

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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

Baseline Characteristics

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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
Number of Participants [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.

Outcome Measures

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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. ]

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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. ]

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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. ]

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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. ]

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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). ]

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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. ]

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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. ]

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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. ]

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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. ]

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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. ]

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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. ]

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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. ]

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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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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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.

Results Point of Contact:

Name/Title: BMS Study Director
Organization: Bristol-Myers Squibb
e-mail: Clinical.Trials@bms.com

No publications provided

Responsible Party:	Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00978731 History of Changes
Other Study ID Numbers:	CA180-039
Study First Received:	September 16, 2009
Results First Received:	November 23, 2010
Last Updated:	April 25, 2011
Health Authority:	United States: Food and Drug Administration

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