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

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ClinicalTrials.gov Identifier: NCT00481247
Recruitment Status : Completed
First Posted : June 1, 2007
Results First Posted : March 15, 2011
Last Update Posted : February 15, 2017
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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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.

Condition or disease Intervention/treatment Phase
Myeloid Leukemia, Chronic Drug: Dasatinib Drug: Imatinib Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 547 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : September 2007
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2015

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Dasatinib Drug: Dasatinib
Tablets, oral, dasatinib 50-140 mg once daily (QD)
Other Names:
  • Sprycel®
  • BMS-354825
Active Comparator: Imatinib Drug: Imatinib
Tablets, oral, imatinib 200-800 mg, QD


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With Best Confirmed Complete Cytogenetic Response (cCCyR) Within 12 Months [ Time Frame: Pretreatment, every 3 months up to 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 :
  1. Percentage of Participants Remaining in Confirmed Complete Cytogenetic Response (cCCyR) [ Time Frame: Years 2, 3, 4 and 5 ]

    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.


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

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

    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.

    .


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

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

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


Other Outcome Measures:
  1. 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 [ Time Frame: From date of last person, first visit to date of last person, last visit (approximately 8 years) ]
    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.

  2. 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 8 years) ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00481247


Locations
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Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:

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

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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00481247    
Other Study ID Numbers: CA180-056
2006-005712-27 ( EudraCT Number )
First Posted: June 1, 2007    Key Record Dates
Results First Posted: March 15, 2011
Last Update Posted: February 15, 2017
Last Verified: December 2016
Keywords provided by Bristol-Myers Squibb:
Chronic Phase Philadelphia Chromosome Positive Chronic Myeloid Leukemia
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Philadelphia Chromosome
Neoplasms by Histologic Type
Neoplasms
Hematologic Diseases
Myeloproliferative Disorders
Bone Marrow Diseases
Chronic Disease
Disease Attributes
 Pathologic Processes
Translocation, Genetic
Chromosome Aberrations
Imatinib Mesylate
Dasatinib
Tyrosine Kinase Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents