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A Phase III Study of Dasatinib vs. Imatinib in Patients With Newly Diagnosed Chronic Phase CML (DASISION)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00481247
First received: May 30, 2007
Last updated: April 30, 2012
Last verified: October 2011
History of Changes
Results First Received: November 23, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Myeloid Leukemia, Chronic
Interventions: Drug: Dasatinib
Drug: Imatinib

  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
A total of 547 subjects were enrolled, 28 were not randomized (20 no longer met study criteria, 3 withdrew consent, 1 lost to follow-up, 4 for other reasons).

Reporting Groups
  Description
Dasatinib Tablets, oral, dasatinib 50-140 mg once daily (QD)
Imatinib Tablets, oral, imatinib 200-800 mg, QD

Participant Flow:   Overall Study
    Dasatinib     Imatinib  
STARTED     259     260  
Randomized and Treated     258     258  
COMPLETED     40     48  
NOT COMPLETED     219     212  
Still On Treatment                 218                 210  
Randomized But Not Treated                 1                 2  



  Baseline Characteristics
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Reporting Groups
  Description
Dasatinib Tablets, oral, dasatinib 50-140 mg once daily (QD)
Imatinib Tablets, oral, imatinib 200-800 mg, QD
Total Total of all reporting groups

Baseline Measures
    Dasatinib     Imatinib     Total  
Number of Participants  
[units: participants]
 		  259     260     519  
Age  
[units: years]
Mean ± Standard Deviation 		  46.4  ± 14.6     47.1  ± 13.9     46.7  ± 14.2  
Age, Customized  
[units: participants]
 		     
<20 years     5     9     14  
Between 21 and 45 years     123     102     225  
Between 46 and 65 years     111     125     236  
Between 66 and 75 years     13     20     33  
>75 years     7     4     11  
Gender  
[units: participants]
 		     
Female     115     97     212  
Male     144     163     307  
Race/Ethnicity, Customized  
[units: participants]
 		     
White     132     143     275  
Black/African American     2     1     3  
Asian     108     95     203  
Other     17     21     38  
Eastern Cooperative Oncology Group (ECOG) Performance Status [1]
[units: participants]
 		     
ECOG Score = 0     213     205     418  
ECOG Score = 1     46     53     99  
ECOG Score = 2     0     2     2  
[1] ECOG PS, a 6-item scale to assess disease progression, daily functioning, and appropriate treatment and prognosis. Scale: 0-5, with 0=Fully active, able to carry on all pre-disease performance without restriction and 5=Death.



  Outcome Measures
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1.  Primary:   Number of Participants With Best Confirmed Complete Cytogenetic Response (cCCyR) Within 12 Months   [ Time Frame: Pre-treatment, every 3 months up to 12 months ]
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2.  Secondary:   Number of Participants With Major Molecular Response (MMR) at Any Time   [ Time Frame: Pre-treatment, every 3 months for 2 years, then every 6 months for 3 years ]
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3.  Secondary:   Time to Confirmed CCyR Overall   [ Time Frame: Every 3 months for 2 years, then once per year for 3 years and/ or once per year for subjects in confirmed complete cytogenetic response at any timepoint ]
  Show Outcome Measure 3

4.  Secondary:   Time to MMR Overall   [ Time Frame: Every 3 months for 2 years, then every 6 months for 3 years ]
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5.  Secondary:   Percentage of Participants With Progression-Free Survival (PFS) at 12 Months   [ Time Frame: Participants were followed for at least 5 years ]
  Hide Outcome Measure 5

Measure Type Secondary
Measure Title Percentage of Participants With Progression-Free Survival (PFS) at 12 Months
Measure Description PFS=time from randomization until progression (any progression/death within 30 days of last dosing date, or between 30-60 days of last dosing prior to start of secondary therapy). Those who did not progress/die or who progressed/died after 60 days of last dose were censored at last on-study hematologic/cytogenetic assessment; those with progression/death 30-60 days of last dosing date & after start date of secondary therapy censored at last on-study hematologic/cytogenetic assessment prior to start of secondary therapy; those who had not received study treatment censored on date randomized.
Time Frame Participants were followed for at least 5 years  
Safety Issue No  

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.
Randomized Participants

Reporting Groups
  Description
Dasatinib Tablets, oral, dasatinib 50-140 mg once daily (QD)
Imatinib Tablets, oral, imatinib 200-800 mg, QD

Measured Values
    Dasatinib     Imatinib  
Number of Participants Analyzed  
[units: participants]
 		  259     260  
Percentage of Participants With Progression-Free Survival (PFS) at 12 Months  
[units: percentage of participants]
Number ( 95% Confidence Interval ) 		  96.4  
  ( 94.1 to 98.7 )   		  96.7  
  ( 94.4 to 99.0 )  

No statistical analysis provided for Percentage of Participants With Progression-Free Survival (PFS) at 12 Months



6.  Secondary:   Percentage of Participants With Overall Survival (OS) at 12 Months   [ Time Frame: Participants were followed for at least 5 years ]
  Show Outcome Measure 6

7.  Other Pre-specified:   Number of Participants With Adverse Events (AEs), Drug-related AEs, Drug-related Grade 3/4 AEs, Drug-related Fluid Retention AEs (FRAEs), Drug-related Serious AEs (SAEs), Drug-related AEs Leading to Discontinuation, and All Deaths   [ Time Frame: Participants were followed for at least 5 years ]
  Show Outcome Measure 7

8.  Other Pre-specified:   Number of Participants With Grade 3/4 On Study Laboratory Abnormalities   [ Time Frame: Participants were followed for at least 5 years ]
  Show Outcome Measure 8

9.  Secondary:   Time-in cCCyR at Any Time   [ Time Frame: Every 3 months for 2 years, then once per year for 3 years and/ or once per year for subjects in confirmed complete cytogenetic response at any timepoint or investigator's decision ]
Results not yet posted.   Anticipated Posting Date:   11/2014   Safety Issue:   No


  Serious Adverse Events
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  Other Adverse Events
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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.


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.  


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


No publications provided by Bristol-Myers Squibb

Publications automatically indexed to this study:


Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00481247     History of Changes
Other Study ID Numbers: CA180-056, 2006-005712-27
Study First Received: May 30, 2007
Results First Received: November 23, 2010
Last Updated: April 30, 2012
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
India: Central Drugs Standard Control Organization
Greece: National Organization of Medicines
Singapore: Clinical Trials & Epidemiology Research Unit (CTERU)
Japan: Pharmaceuticals and Medical Devices Agency
Turkey: Ministry of Health
China: Food and Drug Administration
South Korea: Korea Food and Drug Administration (KFDA)
Czech Republic: State Institute for Drug Control
Hungary: National Institute of Pharmacy
Poland: National Institute of Medicines
Russia: Ministry of Health of the Russian Federation
Austria: Federal Office for Safety in Health Care
Germany: Federal Institute for Drugs and Medical Devices
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Spain: Spanish Agency of Medicines
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Brazil: National Health Surveillance Agency
Chile: CONEP
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Peru: Instituto Nacional de Salud
Mexico: Federal Commission for Sanitary Risks Protection
Denmark: Danish Dataprotection Agency
Italy: Ministry of Health
Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)