Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

May 30, 2007
August 8, 2016
September 2007
December 2009   (final data collection date for primary outcome measure)
Number of Participants With Best Confirmed Complete Cytogenetic Response (cCCyR) Within 12 Months [ Time Frame: Pretreatment, every 3 months up to 12 months ] [ Designated as safety issue: No ]
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.
Complete Cytogenetic Response (CCyR) [ Time Frame: within 12 months ]
Complete list of historical versions of study NCT00481247 on ClinicalTrials.gov Archive Site
  • Percentage of Participants Remaining in Confirmed Complete Cytogenetic Response (cCCyR) [ Time Frame: Years 2, 3, 4 and 5 ] [ Designated as safety issue: No ]

    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 [ Time Frame: Planned total follow-up duration of 5 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day 1 to 5 years ] [ Designated as safety issue: No ]

    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 [ Time Frame: Day 1 to 5 years ] [ Designated as safety issue: No ]
    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) [ Time Frame: Participants were followed-up for at least 5 years ] [ Designated as safety issue: No ]
    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) [ Time Frame: Participants were followed-up for at least 5 years ] [ Designated as safety issue: No ]
    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.
  • Major Molecular Response(MMR), Major Cytogenetic Response (MCyR) and Complete Hematologic Response (CHR) [ Time Frame: within 12 months ]
  • Best overall MMR, CCyR, MCyr, and CHR rate [ Time Frame: throughout the study ]
  • Durations of and times to MMR, CCyR, MCyR and CHR [ Time Frame: throughout the study ]
  • Progression-free survival & overall survival [ Time Frame: throughout the study ]
  • Toxicity profile [ Time Frame: throughout the study ]
  • 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) ] [ Designated as safety issue: Yes ]
    Grade 3=Severe, Grade 4=Life-threatening or disabling. 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.
  • 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) ] [ Designated as safety issue: Yes ]
    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
Not Provided
 
A Phase III Study of Dasatinib vs Imatinib in Patients With Newly Diagnosed Chronic Phase Chronic Myeloid Leukemia
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
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Myeloid Leukemia, Chronic
  • Drug: Dasatinib
    Tablets, oral, dasatinib 50-140 mg once daily (QD)
    Other Names:
    • Sprycel®
    • BMS-354825
  • Drug: Imatinib
    Tablets, oral, imatinib 200-800 mg, QD
  • Experimental: Dasatinib
    Intervention: Drug: Dasatinib
  • Active Comparator: Imatinib
    Intervention: Drug: Imatinib

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
547
December 2015
December 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Australia,   Austria,   Belgium,   Brazil,   Chile,   China,   Colombia,   Czech Republic,   Denmark,   France,   Germany,   Greece,   Hungary,   India,   Italy,   Japan,   Korea, Republic of,   Mexico,   Netherlands,   Peru,   Poland,   Russian Federation,   Singapore,   Spain,   Turkey
Romania
 
NCT00481247
CA180-056, 2006-005712-27
Yes
Not Provided
Not Provided
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP