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
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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 ]

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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 ]

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6. Secondary:

Percentage of Participants With Overall Survival (OS) at 12 Months [ Time Frame: Participants were followed for at least 5 years ]

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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 ]

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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 ]

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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:

	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.

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:

Kantarjian HM, Shah NP, Cortes JE, Baccarani M, Agarwal MB, Undurraga MS, Wang J, Ipiña JJ, Kim DW, Ogura M, Pavlovsky C, Junghanss C, Milone JH, Nicolini FE, Robak T, Van Droogenbroeck J, Vellenga E, Bradley-Garelik MB, Zhu C, Hochhaus A. Dasatinib or imatinib in newly diagnosed chronic-phase chronic myeloid leukemia: 2-year follow-up from a randomized phase 3 trial (DASISION). Blood. 2012 Feb 2;119(5):1123-9. Epub 2011 Dec 9.

Kantarjian H, Shah NP, Hochhaus A, Cortes J, Shah S, Ayala M, Moiraghi B, Shen Z, Mayer J, Pasquini R, Nakamae H, Huguet F, Boqué C, Chuah C, Bleickardt E, Bradley-Garelik MB, Zhu C, Szatrowski T, Shapiro D, Baccarani M. Dasatinib versus imatinib in newly diagnosed chronic-phase chronic myeloid leukemia. N Engl J Med. 2010 Jun 17;362(24):2260-70. Epub 2010 Jun 5.

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)

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