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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00481247
First received: May 30, 2007
Last updated: August 8, 2016
Last verified: August 2016
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
Of the 547 patients enrolled, 519 were randomized and 516 received treatment. Of the 28 who were enrolled but not randomized, 20 no longer met study criteria, 3 withdrew consent, 1 was lost to follow-up, and 4 withdrew 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 [1]   260 [1] 
Received Treatment   258   258 
COMPLETED   11 [2]   0 [2] 
NOT COMPLETED   248   260 
Death                0                1 
Disease progression                18                22 
Intolerance                42                17 
Treatment failure                10                14 
AE unrelated to study drug                12                4 
Withdrawal by Subject                8                13 
Pregnancy                2                1 
Lost to Follow-up                1                2 
Poor compliance/noncompliance                1                7 
Administrative reason by sponsor                147                162 
Varied                6                15 
Did not receive treatment                1                2 
[1] Randomized
[2] Remained on treatment



  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
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 
Overall Participants Analyzed 
[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 is a 6-item scale used to assess disease progression, daily functioning, and appropriate treatment and prognosis. Performance status is scored on a scale ranging from 0-5, with (best score) 0=fully active and able to carry on all predisease performance without restriction and (worst score) 5=death.
Number of Patients With Liver Involvement 
[Units: Participants]
 37   18   55 
Number of Participants With Spleen Involvement 
[Units: Participants]
 83   71   154 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Best Confirmed Complete Cytogenetic Response (cCCyR) Within 12 Months   [ Time Frame: Pretreatment, every 3 months up to 12 months ]

2.  Secondary:   Percentage of Participants Remaining in Confirmed Complete Cytogenetic Response (cCCyR)   [ Time Frame: Years 2, 3, 4 and 5 ]

3.  Secondary:   Percentage of Participants With Major Molecular Response (MMR) at Any Time   [ Time Frame: Planned total follow-up duration of 5 years ]

4.  Secondary:   Time to Confirmed Complete Cytogenic Response (cCCyR) Overall   [ Time Frame: Day 1 to 5 years ]

5.  Secondary:   Time to Major Molecular Response (MMR) Overall   [ Time Frame: Day 1 to 5 years ]

6.  Secondary:   Percentage of Participants With Progression-free Survival (PFS)   [ Time Frame: Participants were followed-up for at least 5 years ]

7.  Secondary:   Percentage of Participants With Overall Survival (OS)   [ Time Frame: Participants were followed-up for at least 5 years ]

8.  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 Adverse Events (SAEs), Drug-related AEs Leading to Discontinuation, and All Deaths   [ Time Frame: From date of last person, first visit to date of last person, last visit (approximately 5 years) ]

9.  Other Pre-specified:   Number of Participants With Grade 3/4 Abnormalities in On-study Laboratory Test Results   [ Time Frame: From date of last person, first visit to date of last person, last visit (approximately 5 years) ]


  Serious Adverse Events


  Other Adverse Events


  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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):


Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00481247     History of Changes
Other Study ID Numbers: CA180-056
2006-005712-27 ( EudraCT Number )
Study First Received: May 30, 2007
Results First Received: November 23, 2010
Last Updated: August 8, 2016
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)