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

Primary Purpose

Myeloid Leukemia, Chronic

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Dasatinib
Imatinib
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myeloid Leukemia, Chronic focused on measuring Chronic Phase Philadelphia Chromosome Positive Chronic Myeloid Leukemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

  • Male or female, aged 18 years and older
  • Chronic phase, Philadelphia Chromosome-positive chronic myeloid leukemia (CML)
  • Eastern Cooperative Oncology Group Performance Status score of 0-2

Key Exclusion Criteria:

  • Pleural Effusion
  • Uncontrolled cardiovascular disease
  • Significant bleeding disorder unrelated to CML
  • Prior treatment with interferon/imatinib/dasatinib/anti-CML systemic treatments except anagrelide/hydroxyurea

Sites / Locations

  • Molecular Md
  • Local Institution
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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Dasatinib

Imatinib

Arm Description

Outcomes

Primary Outcome Measures

Number of Participants With Best Confirmed Complete Cytogenetic Response (cCCyR) Within 12 Months
Cytogenetic response (CyR) is based on the prevalence of Philadelphia positive (Ph+) cells in metaphase from bone marrow (BM) sample. (Ideally, 25 metaphases but at least 20 metaphases from a BM sample were evaluated). Complete Cytogenetic Response (CCyR)=0% Ph+ cells in metaphase in BM. A cCCyR=those in which all measurements up to at least 28 days after the initial response show an equivalent or better CCyR.

Secondary Outcome Measures

Percentage of Participants Remaining in Confirmed Complete Cytogenetic Response (cCCyR)
Cytogenetic response (CyR) is based on the prevalence of Philadelphia positive (Ph+) cells in metaphase from bone marrow (BM) sample. (Ideally, 25 metaphases but at least 20 metaphases from a BM sample were evaluated). Complete Cytogenetic Response (CCyR)=0% Ph+ cells in metaphase in BM. A cCCyR=those in which all measurements up to at least 28 days after the initial response show an equivalent or better CCyR. Percentage of participants in cCCyR at years 2, 3, 4 and 5 was computed for all randomized participants who achieved cCCyR as measured from the time of first confirmation until the date of progression or death. Participants with cCCyR who neither progress nor die are censored on the date of their last cytogenetic assessment. Participants without cCCyR are considered to have progressed on Day 1.
Percentage of Participants With Major Molecular Response (MMR) at Any Time
Molecular response was assessed using BCR-ABL transcript levels measured by realtime quantitative polymerase chain reaction. MMR is defined as a ratio BCR-ABL/ABL ≤0.1% on the international scale (ie, at least 3 log reduction from a standardized baseline value).
Time to Confirmed Complete Cytogenic Response (cCCyR) Overall
The time to cCCyR for all randomized participants is defined as the time from the randomization date until criteria are first met for complete cytogenic response (provided it is confirmed later). The time to cCCyR analysis censors nonresponders who do not progress at their last cytogenetic assessments and nonresponders who progress at the maximum time of all randomized participants. .
Time to Major Molecular Response (MMR) Overall
The time to MMR for all randomized participants is defined as the time from randomization date until measurement criteria are first met for MMR. The time to MMR analysis censors nonresponders who do not progress at their last molecular assessments and nonresponders who progress at the maximum time of all randomized participants.
Percentage of Participants With Progression-free Survival (PFS)
PFS was defined as the 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 and 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.
Percentage of Participants With Overall Survival (OS)
OS was defined as the time from randomization to the date of death. If the participant had not died, survival was censored on last date the participant was known to be alive.

Full Information

First Posted
May 30, 2007
Last Updated
December 22, 2016
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT00481247
Brief Title
A Phase III Study of Dasatinib vs Imatinib in Patients With Newly Diagnosed Chronic Phase Chronic Myeloid Leukemia
Acronym
DASISION
Official Title
An Open-Label, Randomized, Multicenter Phase III Trial of Dasatinib (SPRYCEL®) vs. Standard Dose Imatinib (400 mg) in the Treatment of Subjects With Newly Diagnosed Chronic Phase Philadelphia Chromosome Positive Chronic Myeloid Leukemia
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this clinical research study is to compare the confirmed complete cytogenetic response of dasatinib with that of imatinib within 12 months after randomization in patients with newly diagnosed chronic-phase Philadelphia positive chronic myeloid leukemia. The safety of this treatment will also be studied.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myeloid Leukemia, Chronic
Keywords
Chronic Phase Philadelphia Chromosome Positive Chronic Myeloid Leukemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
547 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dasatinib
Arm Type
Experimental
Arm Title
Imatinib
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Dasatinib
Other Intervention Name(s)
Sprycel®, BMS-354825
Intervention Description
Tablets, oral, dasatinib 50-140 mg once daily (QD)
Intervention Type
Drug
Intervention Name(s)
Imatinib
Intervention Description
Tablets, oral, imatinib 200-800 mg, QD
Primary Outcome Measure Information:
Title
Number of Participants With Best Confirmed Complete Cytogenetic Response (cCCyR) Within 12 Months
Description
Cytogenetic response (CyR) is based on the prevalence of Philadelphia positive (Ph+) cells in metaphase from bone marrow (BM) sample. (Ideally, 25 metaphases but at least 20 metaphases from a BM sample were evaluated). Complete Cytogenetic Response (CCyR)=0% Ph+ cells in metaphase in BM. A cCCyR=those in which all measurements up to at least 28 days after the initial response show an equivalent or better CCyR.
Time Frame
Pretreatment, every 3 months up to 12 months
Secondary Outcome Measure Information:
Title
Percentage of Participants Remaining in Confirmed Complete Cytogenetic Response (cCCyR)
Description
Cytogenetic response (CyR) is based on the prevalence of Philadelphia positive (Ph+) cells in metaphase from bone marrow (BM) sample. (Ideally, 25 metaphases but at least 20 metaphases from a BM sample were evaluated). Complete Cytogenetic Response (CCyR)=0% Ph+ cells in metaphase in BM. A cCCyR=those in which all measurements up to at least 28 days after the initial response show an equivalent or better CCyR. Percentage of participants in cCCyR at years 2, 3, 4 and 5 was computed for all randomized participants who achieved cCCyR as measured from the time of first confirmation until the date of progression or death. Participants with cCCyR who neither progress nor die are censored on the date of their last cytogenetic assessment. Participants without cCCyR are considered to have progressed on Day 1.
Time Frame
Years 2, 3, 4 and 5
Title
Percentage of Participants With Major Molecular Response (MMR) at Any Time
Description
Molecular response was assessed using BCR-ABL transcript levels measured by realtime quantitative polymerase chain reaction. MMR is defined as a ratio BCR-ABL/ABL ≤0.1% on the international scale (ie, at least 3 log reduction from a standardized baseline value).
Time Frame
Planned total follow-up duration of 5 years
Title
Time to Confirmed Complete Cytogenic Response (cCCyR) Overall
Description
The time to cCCyR for all randomized participants is defined as the time from the randomization date until criteria are first met for complete cytogenic response (provided it is confirmed later). The time to cCCyR analysis censors nonresponders who do not progress at their last cytogenetic assessments and nonresponders who progress at the maximum time of all randomized participants. .
Time Frame
Day 1 to 5 years
Title
Time to Major Molecular Response (MMR) Overall
Description
The time to MMR for all randomized participants is defined as the time from randomization date until measurement criteria are first met for MMR. The time to MMR analysis censors nonresponders who do not progress at their last molecular assessments and nonresponders who progress at the maximum time of all randomized participants.
Time Frame
Day 1 to 5 years
Title
Percentage of Participants With Progression-free Survival (PFS)
Description
PFS was defined as the 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 and 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-up for at least 5 years
Title
Percentage of Participants With Overall Survival (OS)
Description
OS was defined as the time from randomization to the date of death. If the participant had not died, survival was censored on last date the participant was known to be alive.
Time Frame
Participants were followed-up for at least 5 years
Other Pre-specified Outcome Measures:
Title
Number of Participants With Adverse Events (AEs), Drug-related AEs, Drug-related Serious Adverse Events (SAEs), Drug-related AEs Leading to Discontinuation, and All Deaths
Description
AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.
Time Frame
From date of last person, first visit to date of last person, last visit (approximately 8 years)
Title
Number of Participants With Grade 3/4 Abnormalities in On-study Laboratory Test Results
Description
ULN=upper limit of normal. Grade 3=Severe AE; Grade 4=Life-threatening or disabling AE. Absolute neutrophil count: Grade 3 <1000-500/mm^3; Grade 4 <500/mm^3. Hemoglobin: Grade 3 <8.0-6.5 g/dL; Grade 4 <6.5 g/dL. Platelets: Grade 3 <50,000-25,000/mm^3; Grade 4 <25,000/mm^3. ALT/AST: Grade 3 >5.0-20*ULN; Grade 4 >20*ULN. Total bilirubin: Grade 3 >3-10*ULN; Grade 4 >10*ULN. Sample normal ranges (may vary by institution): ALT, Female: 7-30 U/L, Male: 10-55 U/L; AST, Female: 9-25 U/L, Male10-40 U/L; Total bilirubin: 0.0-1.0 mg/dL. Creatinine: Grade 3 >3.0-6.0*ULN; Grade 4 >6.0*ULN. Phosphate: Grade 3 <2.0-1.0 mg/dL; Grade 4 <1.0 mg/dL. Calcium: Grade 3 <7.0-6.0 mg/dL; Grade 4 <6.0 mg/dL. Potassium: Grade 3 <3.0-2.5 mmol/L; Grade 4 <2.5 mmol/L.
Time Frame
From date of last person, first visit to date of last person, last visit (approximately 8 years)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Male or female, aged 18 years and older Chronic phase, Philadelphia Chromosome-positive chronic myeloid leukemia (CML) Eastern Cooperative Oncology Group Performance Status score of 0-2 Key Exclusion Criteria: Pleural Effusion Uncontrolled cardiovascular disease Significant bleeding disorder unrelated to CML Prior treatment with interferon/imatinib/dasatinib/anti-CML systemic treatments except anagrelide/hydroxyurea
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Molecular Md
City
Portland
State/Province
Oregon
ZIP/Postal Code
97219
Country
United States
Facility Name
Local Institution
City
Capital Federal
State/Province
Buenos Aires
ZIP/Postal Code
1280
Country
Argentina
Facility Name
Local Institution
City
Capital Federal
State/Province
Buenos Aires
ZIP/Postal Code
C1114AAN
Country
Argentina
Facility Name
Local Institution
City
Buenos Aires
ZIP/Postal Code
1021
Country
Argentina
Facility Name
Local Institution
City
Waratah
State/Province
New South Wales
ZIP/Postal Code
2298
Country
Australia
Facility Name
Local Institution
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Local Institution
City
Greenslopes
State/Province
Queensland
ZIP/Postal Code
4120
Country
Australia
Facility Name
Local Institution
City
Perth
State/Province
Western Australia
ZIP/Postal Code
WA 6000
Country
Australia
Facility Name
Local Institution
City
Innsbruck
ZIP/Postal Code
6020
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Austria
Facility Name
Local Institution
City
Wien
ZIP/Postal Code
1090
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Austria
Facility Name
Local Institution
City
Brugge
ZIP/Postal Code
8000
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Belgium
Facility Name
Local Institution
City
Bruxelles
ZIP/Postal Code
1200
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Belgium
Facility Name
Local Institution
City
Curitiba
State/Province
Parana
ZIP/Postal Code
80060
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Brazil
Facility Name
Local Institution
City
Campinas
State/Province
Sao Paulo
ZIP/Postal Code
13083
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Brazil
Facility Name
Local Institution
City
Jau
State/Province
Sao Paulo
ZIP/Postal Code
17210
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Brazil
Facility Name
Local Institution
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Rio De Janeiro
ZIP/Postal Code
20230130
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Brazil
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Local Institution
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Sao Paulo
ZIP/Postal Code
01401
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Brazil
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Local Institution
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Sao Paulo
ZIP/Postal Code
05403
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Brazil
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Santiago
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Metropolitana
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Chile
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Local Institution
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Beijing
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Beijing
ZIP/Postal Code
100044
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China
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Local Institution
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Fuzhou
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Fujian
ZIP/Postal Code
350001
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China
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Local Institution
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Shanghai
State/Province
Shanghai
ZIP/Postal Code
200025
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China
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Local Institution
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Tianjin
State/Province
Tianjin
ZIP/Postal Code
300020
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China
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Colombia
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Bogota
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Colombia
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Local Institution
City
Bogota
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Colombia
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Brno
ZIP/Postal Code
625 00
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Czech Republic
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Local Institution
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Hradec Kralove
ZIP/Postal Code
500 05
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Czech Republic
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Local Institution
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Olomouc
ZIP/Postal Code
775 20
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Czech Republic
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Local Institution
City
Prague 2
ZIP/Postal Code
128 20
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Czech Republic
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Local Institution
City
Aarhus
ZIP/Postal Code
8000
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Denmark
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Local Institution
City
Nantes
State/Province
Cedex 1
ZIP/Postal Code
44093
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France
Facility Name
Local Institution
City
Brest Cedex 02
ZIP/Postal Code
29609
Country
France
Facility Name
Local Institution
City
Lille Cedex
ZIP/Postal Code
59037
Country
France
Facility Name
Local Institution
City
Limoges
ZIP/Postal Code
87042
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France
Facility Name
Local Institution
City
Montpellier Cedex
ZIP/Postal Code
34295
Country
France
Facility Name
Local Institution
City
Paris Cedex 10
ZIP/Postal Code
75475
Country
France
Facility Name
Local Institution
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Local Institution
City
Pierre Benite Cedex
ZIP/Postal Code
69495
Country
France
Facility Name
Local Institution
City
Poitiers Cedex
ZIP/Postal Code
86021
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France
Facility Name
Local Institution
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
Local Institution
City
Strasbourg Cedex
ZIP/Postal Code
67091
Country
France
Facility Name
Local Institution
City
Toulouse Cedex 09
ZIP/Postal Code
31059
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France
Facility Name
Local Institution
City
Vandoeuvre Les Nancy
ZIP/Postal Code
54511
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France
Facility Name
Local Institution
City
Berlin
ZIP/Postal Code
13353
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Germany
Facility Name
Local Institution
City
Rostock
ZIP/Postal Code
18055
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Germany
Facility Name
Local Institution
City
Tuebingen
ZIP/Postal Code
72076
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Germany
Facility Name
Local Institution
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
Local Institution
City
Thessaloniki
ZIP/Postal Code
57010
Country
Greece
Facility Name
Local Institution
City
Budapest
ZIP/Postal Code
1097
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Hungary
Facility Name
Local Institution
City
Debrecen
ZIP/Postal Code
4012
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Hungary
Facility Name
Local Institution
City
Vellore
State/Province
Tamilnadu
ZIP/Postal Code
632004
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India
Facility Name
Local Institution
City
Ahmedabad
ZIP/Postal Code
380009
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India
Facility Name
Local Institution
City
Cochin
ZIP/Postal Code
682304
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India
Facility Name
Local Institution
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Mumbai
ZIP/Postal Code
400010
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India
Facility Name
Local Institution
City
Mumbai
ZIP/Postal Code
400012
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India
Facility Name
Local Institution
City
Mumbai
ZIP/Postal Code
400014
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India
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Local Institution
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Trivandrum
ZIP/Postal Code
695011
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India
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Local Institution
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Bologna
ZIP/Postal Code
40138
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Italy
Facility Name
Local Institution
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Catania
ZIP/Postal Code
95124
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Italy
Facility Name
Local Institution
City
Monza (mb)
ZIP/Postal Code
20900
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Italy
Facility Name
Local Institution
City
Orbassano (to)
ZIP/Postal Code
10043
Country
Italy
Facility Name
Local Institution
City
Pavia
ZIP/Postal Code
27100
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Italy
Facility Name
Local Institution
City
Roma
ZIP/Postal Code
00144
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Italy
Facility Name
Local Institution
City
Roma
ZIP/Postal Code
00161
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Italy
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Local Institution
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
466-8650
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Japan
Facility Name
Local Institution
City
Kamogawa-shi
State/Province
Chiba
ZIP/Postal Code
2968602
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Japan
Facility Name
Local Institution
City
Fukuoka-shi
State/Province
Fukuoka
ZIP/Postal Code
814-0180
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Japan
Facility Name
Local Institution
City
Morioka-shi
State/Province
Iwate
ZIP/Postal Code
020-8505
Country
Japan
Facility Name
Local Institution
City
Kagoshima-shi
State/Province
Kagoshima
ZIP/Postal Code
890-0064
Country
Japan
Facility Name
Local Institution
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
232-0024
Country
Japan
Facility Name
Local Institution
City
Kyoto-shi
State/Province
Kyoto
ZIP/Postal Code
6028566
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Japan
Facility Name
Local Institution
City
Sendai
State/Province
Miyagi
Country
Japan
Facility Name
Local Institution
City
Okayama-shi
State/Province
Okayama
ZIP/Postal Code
7008558
Country
Japan
Facility Name
Local Institution
City
Osaka-shi
State/Province
Osaka
ZIP/Postal Code
545-8586
Country
Japan
Facility Name
Local Institution
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8677
Country
Japan
Facility Name
Local Institution
City
Shinagawa-ku
State/Province
Tokyo
ZIP/Postal Code
1418625
Country
Japan
Facility Name
Local Institution
City
Seoul
ZIP/Postal Code
137-040
Country
Korea, Republic of
Facility Name
Local Institution
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Facility Name
Local Institution
City
Mexico D.f.
State/Province
Distrito Federal
ZIP/Postal Code
14000
Country
Mexico
Facility Name
Local Institution
City
Mexico, D. F.
State/Province
Distrito Federal
ZIP/Postal Code
06726
Country
Mexico
Facility Name
Local Institution
City
Mexico
State/Province
Distrito Federal
ZIP/Postal Code
02990
Country
Mexico
Facility Name
Local Institution
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Local Institution
City
Culiacan
State/Province
Sinaloa
ZIP/Postal Code
80230
Country
Mexico
Facility Name
Local Institution
City
Groningen
ZIP/Postal Code
9700 RB
Country
Netherlands
Facility Name
Local Institution
City
Nijmegen
ZIP/Postal Code
6500 HB
Country
Netherlands
Facility Name
Local Institution
City
Arequipa
Country
Peru
Facility Name
Local Institution
City
Lima
ZIP/Postal Code
11
Country
Peru
Facility Name
Local Institution
City
Lima
ZIP/Postal Code
34
Country
Peru
Facility Name
Local Institution
City
Chorzow
ZIP/Postal Code
41-500
Country
Poland
Facility Name
Local Institution
City
Krakow
ZIP/Postal Code
31501
Country
Poland
Facility Name
Local Institution
City
Lodz
ZIP/Postal Code
93-510
Country
Poland
Facility Name
Local Institution
City
Poznan
ZIP/Postal Code
60869
Country
Poland
Facility Name
Local Institution
City
Warsaw
ZIP/Postal Code
02776
Country
Poland
Facility Name
Local Institution
City
Moscow
ZIP/Postal Code
125167
Country
Russian Federation
Facility Name
Local Institution
City
Rostov-on-don
ZIP/Postal Code
344022
Country
Russian Federation
Facility Name
Local Institution
City
St.petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
Local Institution
City
Singapore
ZIP/Postal Code
169865
Country
Singapore
Facility Name
Local Institution
City
A Coruna
ZIP/Postal Code
15706
Country
Spain
Facility Name
Local Institution
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Local Institution
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Local Institution
City
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Local Institution
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Local Institution
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Local Institution
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Local Institution
City
Oviedo
ZIP/Postal Code
33006
Country
Spain
Facility Name
Local Institution
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Facility Name
Local Institution
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Facility Name
Local Institution
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Local Institution
City
Kayseri
ZIP/Postal Code
38039
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
30120281
Citation
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PubMed Identifier
26118315
Citation
Hughes TP, Saglio G, Quintas-Cardama A, Mauro MJ, Kim DW, Lipton JH, Bradley-Garelik MB, Ukropec J, Hochhaus A. BCR-ABL1 mutation development during first-line treatment with dasatinib or imatinib for chronic myeloid leukemia in chronic phase. Leukemia. 2015 Sep;29(9):1832-8. doi: 10.1038/leu.2015.168. Epub 2015 Jun 29.
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PubMed Identifier
24357015
Citation
Fujisawa S, Nakamae H, Ogura M, Ishizawa K, Taniwaki M, Utsunomiya A, Matsue K, Takamatsu Y, Usuki K, Tanimoto M, Ishida Y, Akiyama H, Onishi S. Efficacy and safety of dasatinib versus imatinib in Japanese patients with newly diagnosed chronic-phase chronic myeloid leukemia (CML-CP): Subset analysis of the DASISION trial with 2-year follow-up. Int J Hematol. 2014 Feb;99(2):141-53. doi: 10.1007/s12185-013-1470-1. Epub 2013 Dec 20.
Results Reference
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PubMed Identifier
24311723
Citation
Jabbour E, Kantarjian HM, Saglio G, Steegmann JL, Shah NP, Boque C, Chuah C, Pavlovsky C, Mayer J, Cortes J, Baccarani M, Kim DW, Bradley-Garelik MB, Mohamed H, Wildgust M, Hochhaus A. Early response with dasatinib or imatinib in chronic myeloid leukemia: 3-year follow-up from a randomized phase 3 trial (DASISION). Blood. 2014 Jan 23;123(4):494-500. doi: 10.1182/blood-2013-06-511592. Epub 2013 Dec 5.
Results Reference
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PubMed Identifier
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Citation
Kantarjian HM, Shah NP, Cortes JE, Baccarani M, Agarwal MB, Undurraga MS, Wang J, Ipina 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. doi: 10.1182/blood-2011-08-376087. Epub 2011 Dec 9.
Results Reference
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PubMed Identifier
20525995
Citation
Kantarjian H, Shah NP, Hochhaus A, Cortes J, Shah S, Ayala M, Moiraghi B, Shen Z, Mayer J, Pasquini R, Nakamae H, Huguet F, Boque 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. doi: 10.1056/NEJMoa1002315. Epub 2010 Jun 5.
Results Reference
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Links:
URL
http://www.bms.com/studyconnect/Pages/home.aspx
Description
BMS clinical trial educational resource

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

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