Trial · NCT00481247
A Phase III Study of Dasatinib vs Imatinib in Patients With Newly Diagnosed Chronic Phase Chronic Myeloid Leukemia
NCT00481247, Phase 3, Completed, Bristol-Myers Squibb; results first posted 2011-03-15
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Phase III Study of Dasatinib vs Imatinib in Patients With Newly Diagnosed Chronic Phase Chronic Myeloid Leukemia. Trials, record NCT00481247. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00481247
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase III Study of Dasatinib vs Imatinib in Patients With Newly Diagnosed Chronic Phase Chronic Myeloid Leukemia
- NCT number
- NCT00481247
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 547 participants, actual
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- Myeloid Leukemia, Chronic
- Interventions
- Dasatinib, Imatinib
- First posted
- 2007-06-01
- Last updated
- 2017-02-15
- Other registries' IDs
- eudract:2006-005712-27
- Results first posted
- 2011-03-15
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Best Confirmed Complete Cytogenetic Response (cCCyR) Within 12 Months | 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 | Percentage of Participants Remaining in Confirmed Complete Cytogenetic Response (cCCyR) | 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. |
| Secondary | Percentage of Participants With Major Molecular Response (MMR) at Any Time | 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). |
| Secondary | Time to Confirmed Complete Cytogenic Response (cCCyR) Overall | 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. . |
| Secondary | Time to Major Molecular Response (MMR) Overall | 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. |
| Secondary | Percentage of Participants With Progression-free Survival (PFS) | 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. |
| Secondary | Percentage of Participants With Overall Survival (OS) | 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 | 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 | 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. |
| Other | Number of Participants With Grade 3/4 Abnormalities in On-study Laboratory Test Results | 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. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Best Confirmed Complete Cytogenetic Response (cCCyR) Within 12 Months | Pretreatment, every 3 months up to 12 months | All randomized participants | Participants | NUMBER |
| SECONDARY | Percentage of Participants Remaining in Confirmed Complete Cytogenetic Response (cCCyR) | Years 2, 3, 4 and 5 | All randomized participants who achieved cCCyR | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Major Molecular Response (MMR) at Any Time | Planned total follow-up duration of 5 years | All randomized participants | Percentage of participants | NUMBER |
| SECONDARY | Time to Confirmed Complete Cytogenic Response (cCCyR) Overall | Day 1 to 5 years | All randomized participants who achieved cCCyR | Months | MEDIAN |
| SECONDARY | Time to Major Molecular Response (MMR) Overall | Day 1 to 5 years | All participants who received treatment and achieved MMR | Months | MEDIAN |
| SECONDARY | Percentage of Participants With Progression-free Survival (PFS) | Participants were followed-up for at least 5 years | All randomized participants | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Overall Survival (OS) | Participants were followed-up for at least 5 years | All randomized participants | Percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | 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 | From date of last person, first visit to date of last person, last visit (approximately 8 years) | All treated participants | Participants | NUMBER |
| OTHER_PRE_SPECIFIED | Number of Participants With Grade 3/4 Abnormalities in On-study Laboratory Test Results | From date of last person, first visit to date of last person, last visit (approximately 8 years) | Participants with laboratory assessments | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group72
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Best Confirmed Complete Cytogenetic Response (cCCyR) Within 12 Months | Dasatinib | 204 | Participants | ||
| Number of Participants With Best Confirmed Complete Cytogenetic Response (cCCyR) Within 12 Months | Imatinib | 177 | Participants | ||
| Percentage of Participants Remaining in Confirmed Complete Cytogenetic Response (cCCyR) | Dasatinib | At Year 2 | 98.0 | 95% Confidence Interval 94.7 to 99.2 | percentage of participants |
| Percentage of Participants Remaining in Confirmed Complete Cytogenetic Response (cCCyR) | Imatinib | At Year 2 | 96.9 | 95% Confidence Interval 93.2 to 98.6 | percentage of participants |
| Percentage of Participants Remaining in Confirmed Complete Cytogenetic Response (cCCyR) | Dasatinib | At Year 3 | 96.9 | 95% Confidence Interval 93.3 to 98.6 | percentage of participants |
| Percentage of Participants Remaining in Confirmed Complete Cytogenetic Response (cCCyR) | Imatinib | At Year 3 | 95.7 | 95% Confidence Interval 91.6 to 97.8 | percentage of participants |
| Percentage of Participants Remaining in Confirmed Complete Cytogenetic Response (cCCyR) | Dasatinib | At Year 4 | 95.6 | 95% Confidence Interval 91.4 to 97.8 | percentage of participants |
| Percentage of Participants Remaining in Confirmed Complete Cytogenetic Response (cCCyR) | Imatinib | At Year 4 | 95.7 | 95% Confidence Interval 91.6 to 97.8 | percentage of participants |
| Percentage of Participants Remaining in Confirmed Complete Cytogenetic Response (cCCyR) | Dasatinib | At Year 5 | 93.1 | 95% Confidence Interval 86.5 to 96.5 | percentage of participants |
| Percentage of Participants Remaining in Confirmed Complete Cytogenetic Response (cCCyR) | Imatinib | At Year 5 | 91.0 | 95% Confidence Interval 83.6 to 95.2 | percentage of participants |
1 to 10 of 72Source ClinicalTrials.gov
See all 72 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dasatinib | 259 | |
| Overall Study | STARTED | Imatinib | 260 | |
| Overall Study | Received Treatment | Dasatinib | 258 | |
| Overall Study | Received Treatment | Imatinib | 258 | |
| Overall Study | COMPLETED | Dasatinib | 0 | |
| Overall Study | COMPLETED | Imatinib | 0 | |
| Overall Study | NOT COMPLETED | Dasatinib | 259 | |
| Overall Study | NOT COMPLETED | Imatinib | 260 |
Source ClinicalTrials.gov
Adverse events440
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | ANAEMIA | Blood and lymphatic system disorders | Dasatinib | 38 | 258 | |
| other | ANAEMIA | Blood and lymphatic system disorders | Imatinib | 31 | 258 | |
| other | LEUKOPENIA | Blood and lymphatic system disorders | Dasatinib | 21 | 258 | |
| other | LEUKOPENIA | Blood and lymphatic system disorders | Imatinib | 28 | 258 | |
| other | NEUTROPENIA | Blood and lymphatic system disorders | Dasatinib | 60 | 258 | |
| other | NEUTROPENIA | Blood and lymphatic system disorders | Imatinib | 49 | 258 | |
| other | THROMBOCYTOPENIA | Blood and lymphatic system disorders | Dasatinib | 59 | 258 | |
| other | THROMBOCYTOPENIA | Blood and lymphatic system disorders | Imatinib | 48 | 258 | |
| other | EYELID OEDEMA | Eye disorders | Dasatinib | 7 | 258 | |
| other | EYELID OEDEMA | Eye disorders | Imatinib | 40 | 258 |
1 to 10 of 440Source ClinicalTrials.gov
See all 440 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dasatinib | ||
| Total, all-cause mortality | Imatinib | ||
| Total, other adverse events | Dasatinib | 216 | 258 |
| Total, other adverse events | Imatinib | 231 | 258 |
| Total, serious adverse events | Dasatinib | 90 | 258 |
| Total, serious adverse events | Imatinib | 70 | 258 |
Source ClinicalTrials.gov
Papers6
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Dasatinib vs Imatinib: Number of Participants With Best Confirmed Complete Cytogenetic Response (cCCyR) Within 12 Months | Trial comparisons |
| Dasatinib vs Imatinib: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00481247
GET https://conductscience.org/api/trials/v1/NCT00481247/results?page=2