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A Phase II Study of Dasatinib in Children and Adolescents With Newly Diagnosed Chronic Phase CML or With Ph+ Leukemias Resistant or Intolerant to Imatinib

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ClinicalTrials.gov Identifier: NCT00777036
Recruitment Status : Active, not recruiting
First Posted : October 22, 2008
Results First Posted : January 5, 2018
Last Update Posted : January 29, 2018
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Leukemia
Intervention: Drug: Dasatinib

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were enrolled at 80 sites (Argentina, Australia, Brazil, Canada, France, Germany, Great Britain, India, Italy, Korea, Mexico, Netherlands, Romania, Russia, Singapore, South Africa, Spain, and USA).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 145 participants were enrolled and 130 participants were treated in the study. Reasons for non-treatment include 2 withdrew consent, 1 died, 11 failed to meet study criteria, and 1 other non-specified.

Reporting Groups
  Description
Cohort 1 Children and adolescents with CP-CML who were resistant or intolerant to imatinib received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.
Cohort 2 Children and adolescents with Ph+ ALL, AP-CML or BP-CML who were resistant or intolerant to, or relapsed after imatinib therapy received dasatinib tablets at a dose schedule of 80 mg/m2 QD on a continuous oral regimen.
Cohort 3 Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD or powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.

Participant Flow for 2 periods

Period 1:   On Treatment
    Cohort 1   Cohort 2   Cohort 3
STARTED   29   17   84 
COMPLETED   14 [1]   1 [1]   61 [1] 
NOT COMPLETED   15   16   23 
Reason Not Specified                4                7                12 
Failure to Meet Study Criteria                0                1                0 
Non-compliance with Study Drug                1                0                0 
Maximum Clinical Benefit                2                0                1 
Withdrawal by Subject                3                2                3 
Death                0                2                0 
Study Drug Toxicity                0                0                1 
Progressive Disease                5                4                6 
[1] Completed = Still on treatment

Period 2:   Follow-Up
    Cohort 1   Cohort 2   Cohort 3
STARTED   14 [1]   13 [1]   23 [1] 
COMPLETED   9 [2]   5 [2]   19 [2] 
NOT COMPLETED   5   8   4 
Lost to Follow-up                1                0                0 
Reason Not Specified                2                0                0 
Withdrawal by Subject                1                0                4 
Death                1                8                0 
[1] Not all participants who discontinued treatment entered the follow-up period
[2] Completed = Still in Follow-up



  Baseline Characteristics

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
Cohort 1 Children and adolescents with CP-CML who were resistant or intolerant to imatinib received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.
Cohort 2 Children and adolescents with Ph+ ALL, AP-CML or BP-CML who were resistant or intolerant to, or relapsed after imatinib therapy received dasatinib tablets at a dose schedule of 80 mg/m2 QD on a continuous oral regimen.
Cohort 3 Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD or powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
Total Total of all reporting groups

Baseline Measures
   Cohort 1   Cohort 2   Cohort 3   Total 
Overall Participants Analyzed 
[Units: Participants]
 29   17   84   130 
Age 
[Units: Years]
Mean (Standard Deviation)
 12.60  (4.774)   12.10  (3.680)   11.95  (4.418)   12.12  (4.388) 
Age, Customized 
[Units: Participants]
       
< 2 years   1   0   2   3 
>= 2 to < 7 years   3   2   10   15 
>= 7 to < 12 years   6   6   28   40 
>= 12 to < 18 years   17   9   44   70 
>= 18 years   2   0   0   2 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      16  55.2%      9  52.9%      39  46.4%      64  49.2% 
Male      13  44.8%      8  47.1%      45  53.6%      66  50.8% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
       
Hispanic or Latino      2   6.9%      0   0.0%      5   6.0%      7   5.4% 
Not Hispanic or Latino      4  13.8%      0   0.0%      20  23.8%      24  18.5% 
Unknown or Not Reported      23  79.3%      17 100.0%      59  70.2%      99  76.2% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
       
White   20   13   56   89 
Black or African American   2   0   4   6 
Asian   6   3   23   32 
American Indian or Alaska Native   0   0   1   1 
Other   1   1   0   2 


  Outcome Measures

1.  Primary:   Major Cytogenetic Response (MCyR) Rate   [ Time Frame: From first dose of study therapy until 30 days after last dose (Assessed up to September 2016, approximately 90 months) ]

2.  Primary:   Complete Hematologic Response (CHR) Rate   [ Time Frame: From first dose of study therapy until 30 days after last dose (Assessed up to September 2016, approximately 90 months) ]

3.  Primary:   Complete Cytogenetic Response (CCyR) Rate   [ Time Frame: From first dose of study therapy until 30 days after last dose (Assessed up to September 2016, approximately 90 months) ]

4.  Secondary:   Major Cytogenetic Response (MCyR) Rate in Cohort 2   [ Time Frame: From first dose of study therapy until 30 days after last dose (Assessed up to September 2016, approximately 90 months) ]

5.  Secondary:   Complete Hematologic Response (CHR) Rate in Cohorts 1 and 3   [ Time Frame: From first dose of study therapy until 30 days after last dose (Assessed up to September 2016, approximately 90 months) ]

6.  Secondary:   Rate of Best Cytogenetic Response   [ Time Frame: From first dose of study therapy until 30 days after last dose (Assessed up to September 2016, approximately 90 months) ]

7.  Secondary:   Time to Major Cytogenetic Response (MCyR)   [ Time Frame: From first dose until MCyR criteria are met (assessed up to September 2016, approximately 90 months) ]

8.  Secondary:   Duration of Major Cytogenetic Response (MCyR)   [ Time Frame: From first day criteria are met for MCyR until the date PD is reported or death (assessed up to September 2016, approximately 90 months) ]

9.  Secondary:   Time to Complete Cytogenetic Response (CCyR)   [ Time Frame: From first dose until CCyR criteria are met, assessed up to September 2016 (approximately 90 months) ]

10.  Secondary:   Duration of Complete Cytogenetic Response (CCyR)   [ Time Frame: From first day criteria are met for CCyR until the date of progressive disease or death (assessed up to September 2016, approximately 90 months) ]

11.  Secondary:   Progression-Free Survival (PFS) Rate at 2 Years   [ Time Frame: 2 years ]

12.  Secondary:   Time to Complete Hematologic Response (CHR)   [ Time Frame: From first dose until CHR criteria are met, assessed up to September 2016 (approximately 90 months) ]

13.  Secondary:   Duration of Complete Hematologic Response (CHR)   [ Time Frame: From first day criteria are met for CHR until date of disease progression or death (assessed up to September 2016, approximately 90 months) ]

14.  Secondary:   Disease-Free Survival Rate at 2 Years   [ Time Frame: 2 years ]

15.  Secondary:   Overall Survival (OS) Rate at 2 Years   [ Time Frame: 2 years ]

16.  Secondary:   Major Molecular Response (MMR) Rate   [ Time Frame: From date of first treatment to date of MMR (assessed up to September 2016, approximately 90 months) ]

17.  Secondary:   Complete Molecular Response (CMR) Rate   [ Time Frame: From date of first treatment to date of CMR (assessed up to September 2016, approximately 90 months) ]

18.  Secondary:   Major Cytogenetic Response (MCyR) Rate up to 2 Years   [ Time Frame: 24 months ]

19.  Secondary:   Complete Cytogenetic Response (CCyR) Rate up to 2 Years   [ Time Frame: 24 months ]

20.  Secondary:   Major Molecular Response (MMR) Rate up to 2 Years   [ Time Frame: 24 months ]

21.  Secondary:   Complete Molecular Response (CMR) Rate up to 2 Years   [ Time Frame: 24 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
No text entered.


  More Information

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



Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00777036     History of Changes
Other Study ID Numbers: CA180-226
2008-002260-33 ( EudraCT Number )
First Submitted: October 21, 2008
First Posted: October 22, 2008
Results First Submitted: December 6, 2017
Results First Posted: January 5, 2018
Last Update Posted: January 29, 2018