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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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

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.
No text entered.

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. ]
  Show Outcome Measure 1

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. ]
  Show Outcome Measure 2

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. ]
  Show Outcome Measure 3

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. ]
  Show Outcome Measure 4

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). ]
  Show Outcome Measure 5

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. ]
  Show Outcome Measure 6

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. ]
  Show Outcome Measure 7

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. ]
  Show Outcome Measure 8

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. ]
  Show Outcome Measure 9

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. ]
  Show Outcome Measure 10

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. ]
  Show Outcome Measure 11

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. ]
  Show Outcome Measure 12


  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:
unchecked 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.
unchecked 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.


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



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