TriangleNCT00481247 · CITED IN SOURCE DOCUMENTS
A Phase III Study of Dasatinib vs Imatinib in Patients With Newly Diagnosed Chronic Phase Chronic Myeloid Leukemia
An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.
- Phase
- PHASE3
- Status at capture
- COMPLETED
- Registry last update
- 2017-02-15
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.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Participant flow
Baseline characteristics
Number of Participants With Best Confirmed Complete Cytogenetic Response (cCCyR) Within 12 Months
Percentage of Participants Remaining in Confirmed Complete Cytogenetic Response (cCCyR)
Percentage of Participants With Major Molecular Response (MMR) at Any Time
Time to Confirmed Complete Cytogenic Response (cCCyR) Overall
Time to Major Molecular Response (MMR) Overall
Percentage of Participants With Progression-free Survival (PFS)
Percentage of Participants With Overall Survival (OS)
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
Number of Participants With Grade 3/4 Abnormalities in On-study Laboratory Test Results
Adverse events
Limitations, agreements, and source contact
Who could take part
- 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
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- intervention Names
- Drug: Dasatinib
- label
- Dasatinib
- type
- EXPERIMENTAL
- intervention Names
- Drug: Imatinib
- label
- Imatinib
- type
- ACTIVE_COMPARATOR
- interventions
- arm Group Labels
- Dasatinib
- description
- Tablets, oral, dasatinib 50-140 mg once daily (QD)
- name
- Dasatinib
- other Names
- Sprycel®
- BMS-354825
- type
- DRUG
- arm Group Labels
- Imatinib
- description
- Tablets, oral, imatinib 200-800 mg, QD
- name
- Imatinib
- type
- DRUG
Study design
- allocation
- RANDOMIZED
- intervention Model
- PARALLEL
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 547
- type
- ACTUAL
Registered outcome plans (not posted results)
- other Outcomes
- 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.
- measure
- 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)
- 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.
- measure
- 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)
- primary Outcomes
- 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.
- measure
- Number of Participants With Best Confirmed Complete Cytogenetic Response (cCCyR) Within 12 Months
- time Frame
- Pretreatment, every 3 months up to 12 months
- secondary Outcomes
- 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.
- measure
- Percentage of Participants Remaining in Confirmed Complete Cytogenetic Response (cCCyR)
- time Frame
- Years 2, 3, 4 and 5
- 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).
- measure
- Percentage of Participants With Major Molecular Response (MMR) at Any Time
- time Frame
- Planned total follow-up duration of 5 years
- 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. .
- measure
- Time to Confirmed Complete Cytogenic Response (cCCyR) Overall
- time Frame
- Day 1 to 5 years
- 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.
- measure
- Time to Major Molecular Response (MMR) Overall
- time Frame
- Day 1 to 5 years
- 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.
- measure
- Percentage of Participants With Progression-free Survival (PFS)
- time Frame
- Participants were followed-up for at least 5 years
- 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.
- measure
- Percentage of Participants With Overall Survival (OS)
- time Frame
- Participants were followed-up for at least 5 years
Full 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.
Source references
- references
- citation
- Glauche I, Kuhn M, Baldow C, Schulze P, Rothe T, Liebscher H, Roy A, Wang X, Roeder I. Quantitative prediction of long-term molecular response in TKI-treated CML - Lessons from an imatinib versus dasatinib comparison. Sci Rep. 2018 Aug 17;8(1):12330. doi: 10.1038/s41598-018-29923-4.
- pmid
- 30120281
- type
- DERIVED
- 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.
- pmid
- 26118315
- type
- DERIVED
- 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.
- pmid
- 24357015
- type
- DERIVED
- 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.
- pmid
- 24311723
- type
- DERIVED
- 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.
- pmid
- 22160483
- type
- DERIVED
- 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.
- pmid
- 20525995
- type
- DERIVED
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Preserved source evidence · Not medical advice