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
|Condition or disease||Intervention/treatment||Phase|
|Myeloid Leukemia, Chronic||Drug: Dasatinib Drug: Imatinib||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||547 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
Tablets, oral, dasatinib 50-140 mg once daily (QD)
|Active Comparator: Imatinib||
Tablets, oral, imatinib 200-800 mg, QD
- 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.
- 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.
- 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).
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00481247
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|Study Director:||Bristol-Myers Squibb||Bristol-Myers Squibb|