Trial · NCT00482703
A Study of Dasatinib in Chronic Phase Philadelphia Chromosome Positive Chronic Myeloid Leukemia
NCT00482703, Phase 1, Phase 2, Completed, Bristol-Myers Squibb; results first posted 2010-11-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Dasatinib in Chronic Phase Philadelphia Chromosome Positive Chronic Myeloid Leukemia. Trials, record NCT00482703. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00482703
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Dasatinib in Chronic Phase Philadelphia Chromosome Positive Chronic Myeloid Leukemia
- NCT number
- NCT00482703
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 23 participants, actual
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- Myeloid Leukemia, Chronic
- Interventions
- Dasatinib, dasatinib
- First posted
- 2007-06-05
- Last updated
- 2010-12-17
- Results first posted
- 2010-11-30
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Cytogenetic Response in Imatinib-Intolerant and Imatinib-Resistant Participants at Week 24 | Week 24 | Cytogenetic responses (CyR) are based on the percentage of Philadelphia-positive (Ph+) metaphases among at least 20 metaphase cells in each bone marrow (BM) sample. The criteria for cytogenetic responses are as follows. Best CyR is defined as the best response obtained at any time during the study. Major Cytogenetic Response (MCyR) = Complete Cytogenetic Response (CCyR; 0 Ph+ Cells in Metaphase in BM), and Partial Cytogenetic Response (PCyR; 1 - 35 Ph+ Cells in Metaphase in BM). |
| Secondary | Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuations, and Deaths During Treatment | Throughout study period to last observation. Dosing period=6 months; if beneficial, medication may continue in the extension period (ending in January 2009). Last observation=30 days past last dosing day or the discontinuation day. | AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. 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, results in the development of drug dependency or drug abuse, is an important medical event. |
| Secondary | Complete Hematologic Response (CHR) in Imatinib-Intolerant and Imatinib-Resistant Participants at Week 24 | Week 24 | CHR=all of the following criteria: white blood cell count ≤ institutional upper limit of normal; platelets \< 450,000/mm³; no blasts or promyelocytes in peripheral blood; \< 5% myelocytes plus metamyelocytes in peripheral blood; peripheral blood basophils \< 20%; no extramedullary involvement. A confirmed CHR (cCHR) is obtained when all above criteria are maintained for at least 28 days after they are first met. All hematologic responses can begin only 14 days after the dosing start date. |
| Secondary | Time to Major Cytogenetic Response (MCyR) | time from first dose of Dasatinib (BMS-354825) until the first day criteria for CCyR or PCyR, whichever occurs first, are first met | Time to MCyR is defined as the time from first dose of Dasatinib (BMS-354825) until the first day criteria for CCyR or PCyR, whichever occurs first, are first met. MCyR = a complete and a partial cytogenetic response (CyR), based on the percentage of Ph+ metaphases among at least 20 metaphase cells in each bone marrow sample. Percentage of Ph+ Cells in Metaphase in bone marrow: Complete Cytogenetic Response (CCyR) = 0; Partial Cytogenetic Response (PCyR) 1 - 35 |
| Secondary | Pharmacokinetics of Dasatinib (BMS-354825) as Characterized by Population Pharmacokinetics | Six or more peripheral blood samples were collected at any visit after Day 7, pre-dose and 5 - 8 hours after dose administration. | Blood sample collection for pharmacokinetic (PK) analysis that will contribute to PK modeling. |
| Secondary | Duration of MCyR | from the first day all criteria are met for CCyR or PCyR until the date of progressed disease (PD) or death | The duration of MCyR will be measured from the first day all criteria are met for CCyR or PCyR until the date of progressed disease (PD) or death. Subjects who neither progress nor die will be censored on the date of their last cytogenetic assessment.MCyR = a complete and a partial cytogenetic response (CyR), based on the percentage of Ph+ metaphases among at least 20 metaphase cells in each bone marrow sample. Percentage of Philadelphia-positive (Ph+) Cells in Metaphase in bone marrow: Complete Cytogenetic Response (CCyR) = 0; Partial Cytogenetic Response (PCyR) 1 - 35 |
| Secondary | Time to CHR | time from first dose of Dasatinib (BMS-354825) until the first day CHR criteria are met | Time to CHR = time from first dose of Dasatinib until the first day CHR criteria are met (provided subjects achieved a cCHR). CHR=all of the following criteria: white blood cell count ≤ upper limit of normal; platelets \<450,000/mm³; no blasts or promyelocytes in peripheral blood; \<5% myelocytes plus metamyelocytes in peripheral blood; peripheral blood basophils \<20%; no extramedullary involvement. A confirmed CHR (cCHR) is obtained when all above criteria are maintained for at least 28 days after they are first met. All hematologic responses can begin only 14 days after the dosing start date. |
| Secondary | Duration of CHR | measured from the first day all criteria were first met for CHR (provided subjects achieved a cCHR), until the date PD is first reported or until death | The duration of CHR were measured from the first day all criteria were first met for CHR (provided subjects achieved a cCHR), until the date PD is first reported or until death. Subjects who neither progress nor die were censored on the date of their last hematologic assessment. |
| Secondary | Progression-Free Survival (PFS) | time from first dose of Dasatinib (BMS-354825) until the first day criteria for CCyR or PCyR, whichever occurs first, are first met | Progressed disease=achieving a CHR \& subsequently no longer meeting criteria consistently over a consecutive 2-week period after starting maximum dose; no CHR after receiving maximum dose \& increase in white blood cell count (doubling of count from lowest value to \>20,000/mm3 or an increase by \>50,000/mm3 on 2 assessments done ≥2 weeks apart); meeting the criteria of accelerated or blastic phase chronic myeloid leukemia at any time; having an MCyR \& subsequently no longer meeting the criteria for MCyR after starting maximum dose; or having a \>=30% absolute increase in number of Ph+ metaphases. |
| Secondary | Expression of BCR-ABL Gene Mutations of RNA (mRNA) | Baseline and at the end of long term extension period (The enrollment period was followed by an extension period until the launch of dasatinib in Japan, January 2009.) | Number of participants with positive (\>= 2.0 log copies/mg) and negative (\<2.0 log copies/mg) expression of mRNA at Baseline and at end of study. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Cytogenetic Response in Imatinib-Intolerant and Imatinib-Resistant Participants at Week 24 | Week 24 | All treated participants | percentage of participants | NUMBER |
| SECONDARY | Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuations, and Deaths During Treatment | Throughout study period to last observation. Dosing period=6 months; if beneficial, medication may continue in the extension period (ending in January 2009). Last observation=30 days past last dosing day or the discontinuation day. | All treated participants | participants | NUMBER |
| SECONDARY | Complete Hematologic Response (CHR) in Imatinib-Intolerant and Imatinib-Resistant Participants at Week 24 | Week 24 | All treated participants | percentage of participants | NUMBER |
| SECONDARY | Time to Major Cytogenetic Response (MCyR) | time from first dose of Dasatinib (BMS-354825) until the first day criteria for CCyR or PCyR, whichever occurs first, are first met | Treated participants - responders | months | MEDIAN |
| SECONDARY | Pharmacokinetics of Dasatinib (BMS-354825) as Characterized by Population Pharmacokinetics | Six or more peripheral blood samples were collected at any visit after Day 7, pre-dose and 5 - 8 hours after dose administration. | Blood samples were collected for PK to be included in separate population PK analyses. No study specific PK analyses were planned for this report. | participants | NUMBER |
| SECONDARY | Duration of MCyR | from the first day all criteria are met for CCyR or PCyR until the date of progressed disease (PD) or death | Median duration was not reached at the time of this report; see Outcome Measure 14 for corresponding life table. | months | MEDIAN |
| SECONDARY | Time to CHR | time from first dose of Dasatinib (BMS-354825) until the first day CHR criteria are met | Treated participants - responders | months | MEDIAN |
| SECONDARY | Duration of CHR | measured from the first day all criteria were first met for CHR (provided subjects achieved a cCHR), until the date PD is first reported or until death | Median duration of CHR was not reach at the time of this report. See corresponding life table presented in Outcome Measure 15. | months | MEDIAN |
| SECONDARY | Progression-Free Survival (PFS) | time from first dose of Dasatinib (BMS-354825) until the first day criteria for CCyR or PCyR, whichever occurs first, are first met | Median months of progression-free survival was not reached at the time of this report. See corresponding life table in Outcome Measure 16. | months | MEDIAN |
| SECONDARY | Expression of BCR-ABL Gene Mutations of RNA (mRNA) | Baseline and at the end of long term extension period (The enrollment period was followed by an extension period until the launch of dasatinib in Japan, January 2009.) | Treated participants | participants | NUMBER |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group98
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Cytogenetic Response in Imatinib-Intolerant and Imatinib-Resistant Participants at Week 24 | Dasatinib 100 mg QD Starting Dose Cohort | MCyR | 45 | 95% Confidence Interval 16.7 to 76.6 | percentage of participants |
| Cytogenetic Response in Imatinib-Intolerant and Imatinib-Resistant Participants at Week 24 | Dasatinib 100 mg QD Starting Dose - Imatinib-resistant | MCyR | 29 | 95% Confidence Interval 3.7 to 71.0 | percentage of participants |
| Cytogenetic Response in Imatinib-Intolerant and Imatinib-Resistant Participants at Week 24 | Dasatinib 100 mg QD Starting Dose - Imatinib-intolerant | MCyR | 75 | 95% Confidence Interval 19.4 to 99.4 | percentage of participants |
| Cytogenetic Response in Imatinib-Intolerant and Imatinib-Resistant Participants at Week 24 | Dasatinib 50 mg BID Starting Dose Cohort | MCyR | 92 | 95% Confidence Interval 61.5 to 99.8 | percentage of participants |
| Cytogenetic Response in Imatinib-Intolerant and Imatinib-Resistant Participants at Week 24 | Dasatinib 50 mg BID Starting Dose - Imatinib-resistant | MCyR | 86 | 95% Confidence Interval 42.1 to 99.6 | percentage of participants |
| Cytogenetic Response in Imatinib-Intolerant and Imatinib-Resistant Participants at Week 24 | Dasatinib 50 mg BID Starting Dose - Imatinib-intolerant | MCyR | 100 | 95% Confidence Interval 47.8 to 100.0 | percentage of participants |
| Cytogenetic Response in Imatinib-Intolerant and Imatinib-Resistant Participants at Week 24 | Dasatinib 100 mg QD Starting Dose Cohort | CCyR | 27 | 95% Confidence Interval 6.0 to 61.0 | percentage of participants |
| Cytogenetic Response in Imatinib-Intolerant and Imatinib-Resistant Participants at Week 24 | Dasatinib 100 mg QD Starting Dose - Imatinib-resistant | CCyR | 14 | 95% Confidence Interval 0.4 to 57.9 | percentage of participants |
| Cytogenetic Response in Imatinib-Intolerant and Imatinib-Resistant Participants at Week 24 | Dasatinib 100 mg QD Starting Dose - Imatinib-intolerant | CCyR | 50 | 95% Confidence Interval 6.8 to 93.2 | percentage of participants |
| Cytogenetic Response in Imatinib-Intolerant and Imatinib-Resistant Participants at Week 24 | Dasatinib 50 mg BID Starting Dose Cohort | CCyR | 58 | 95% Confidence Interval 27.7 to 84.8 | percentage of participants |
1 to 10 of 98Source ClinicalTrials.gov
See all 98 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dasatinib 100 mg Once-daily (QD) Starting Dose | 11 | |
| Overall Study | STARTED | Dasatinib 50 mg Twice-daily (BID) Starting Dose | 12 | |
| Overall Study | COMPLETED | Dasatinib 100 mg Once-daily (QD) Starting Dose | 10 | |
| Overall Study | COMPLETED | Dasatinib 50 mg Twice-daily (BID) Starting Dose | 12 | |
| Overall Study | NOT COMPLETED | Dasatinib 100 mg Once-daily (QD) Starting Dose | 1 | |
| Overall Study | NOT COMPLETED | Dasatinib 50 mg Twice-daily (BID) Starting Dose | 0 |
Source ClinicalTrials.gov
Adverse events420
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 100 mg Once-daily (QD) Starting Dose | 6 | 11 | |
| other | Anaemia | Blood and lymphatic system disorders | Dasatinib 50 mg Twice-daily (BID) Starting Dose | 6 | 12 | |
| other | Anaemia | Blood and lymphatic system disorders | Total | 12 | 23 | |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Dasatinib 100 mg Once-daily (QD) Starting Dose | 1 | 11 | |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Dasatinib 50 mg Twice-daily (BID) Starting Dose | 0 | 12 | |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Total | 1 | 23 | |
| other | Pericardial effusion | Cardiac disorders | Dasatinib 100 mg Once-daily (QD) Starting Dose | 1 | 11 | |
| other | Pericardial effusion | Cardiac disorders | Dasatinib 50 mg Twice-daily (BID) Starting Dose | 2 | 12 | |
| other | Pericardial effusion | Cardiac disorders | Total | 3 | 23 | |
| other | Cardiac failure | Cardiac disorders | Dasatinib 100 mg Once-daily (QD) Starting Dose | 0 | 11 |
1 to 10 of 420Source ClinicalTrials.gov
See all 420 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dasatinib 100 mg Once-daily (QD) Starting Dose | ||
| Total, all-cause mortality | Dasatinib 50 mg Twice-daily (BID) Starting Dose | ||
| Total, all-cause mortality | Total | ||
| Total, other adverse events | Dasatinib 100 mg Once-daily (QD) Starting Dose | 11 | 11 |
| Total, other adverse events | Dasatinib 50 mg Twice-daily (BID) Starting Dose | 12 | 12 |
| Total, other adverse events | Total | 23 | 23 |
| Total, serious adverse events | Dasatinib 100 mg Once-daily (QD) Starting Dose | 4 | 11 |
| Total, serious adverse events | Dasatinib 50 mg Twice-daily (BID) Starting Dose | 6 | 12 |
| Total, serious adverse events | Total | 10 | 23 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT00482703
GET https://conductscience.org/api/trials/v1/NCT00482703/results?page=2