Trial · NCT00320190
Study of Dasatinib in Patients With Chronic Phase Chronic Myeloid Leukemia and a Suboptimal Response to Imatinib
NCT00320190, Phase 2, Terminated, Bristol-Myers Squibb; results first posted 2011-07-07
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Dasatinib in Patients With Chronic Phase Chronic Myeloid Leukemia and a Suboptimal Response to Imatinib. Trials, record NCT00320190. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00320190
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Dasatinib in Patients With Chronic Phase Chronic Myeloid Leukemia and a Suboptimal Response to Imatinib
- NCT number
- NCT00320190
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 52 participants, actual
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- Leukemia, Myeloid, Chronic
- Interventions
- Imatinib, Dasatinib
- First posted
- 2006-05-03
- Last updated
- 2013-10-30
- Other registries' IDs
- eudract:2005-005153-22
- Results first posted
- 2011-07-07
- Limitations and caveats
Enrollment terminated prematurely on September 5, 2008, due to slow accrual. Only 32 of 156 planned participants were randomized from August 2, 2006. Per BMS standards, findings were reported in a synopsis format, with only safety results included.
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Chronic Phase Chronic Myeloid Leukemia Who Have a Major Molecular Response (MMolR) | At 12 months from baseline | MMolR is defined as reduction in transcript levels of the breakpoint cluster region (BCR)-V-abl Abelson murine leukemia viral oncogene homolog 1 (ABL) gene of at least 3 log. The BCR-ABL gene has a role in the production of a mutated protein that converts bone marrow stem cells from normal to leukemic. |
| Secondary | Percentage of Participants With Death as Outcome, Adverse Events (AEs), Treatment-related AEs, Serious Adverse Events (SAEs), Treatment-related SAEs, and AEs Leading to Discontinuation | Months 1 to 12, continuously, and Months 12 to 24, continuously | AE=any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with treatment. SAE=any untoward medical occurrence that at any dose results in death, persistent or significant disability/incapacity, drug dependency, or drug abuse; prolongs inpatient hospitalization; or is life-threatening, a congenital anomaly/birth defect, or an important medical event. Treatment related=possibly, probably, or certainly related to and of unknown relationship to study treatment. |
| Secondary | Percentage of Participants With On-study AEs of Special Interest | Months 1 to 12, continuously, and Months 12 to 24, continuously | GI=gastrointestinal. AE=any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with treatment. Grade 1=mild; Grade 2=moderate; Grade 3=severe and undesirable; Grade 4=life-threatening or disabling; Grade 5=death. Percentages based on the number of participants with a specific grade at baseline. Participants without on-study test values for a particular laboratory analyte are not included in the reporting of that analyte. |
| Secondary | Median Time to MMolR | At 3, 6, 9, and 12 months from baseline | Time to MMolR is defined as the time from first treatment dose until measurement criteria are first met for MMolR. MMolR is defined as a reduction in transcript levels of the BCR-ABL gene of at least 3 log from baseline. |
| Secondary | Percentage of Participants With Complete Cytogenetic Response | At 6 and 12 months from baseline | Cytogenetic response is based on the prevalence of Ph+ metaphases among cells in metaphase in a bone marrow sample. |
| Secondary | Median Time to Treatment Failure | Randomization to disease progression, death, or discontinuation (to 12 months) | Time to treatment failure is defined as the time in days from randomization to progressive disease documented by the investigator, to death from any cause without prior progression, or to early treatment discontinuation for any reason, whichever occurs first. Participants without disease progression or who do not die and complete the 12-month study treatment are censored on the date of their last molecular, cytogenetic, or hematologic assessment. |
| Secondary | Median Time to Progression-free Survival | Randomization to disease progression or death (to 12 months) | Progression-free survival is defined as the time in days from randomization to progressive disease documented by the investigator or to death from any cause without prior progression. Participants without progressive disease or who do not die and complete the 12-month treatment are censored on the date of their last molecular, cytogenetic, or hematologic assessment. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Chronic Phase Chronic Myeloid Leukemia Who Have a Major Molecular Response (MMolR) | At 12 months from baseline | Efficacy analyses as originally described in the protocol were not conducted because of the low number of participants enrolled. | ||
| SECONDARY | Percentage of Participants With Death as Outcome, Adverse Events (AEs), Treatment-related AEs, Serious Adverse Events (SAEs), Treatment-related SAEs, and AEs Leading to Discontinuation | Months 1 to 12, continuously, and Months 12 to 24, continuously | All participants who received at least 1 dose of dasatinib or imatinib. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With On-study AEs of Special Interest | Months 1 to 12, continuously, and Months 12 to 24, continuously | All participants who received at least 1 dose of dasatinib or imatinib. | Percentage of Participants | NUMBER |
| SECONDARY | Median Time to MMolR | At 3, 6, 9, and 12 months from baseline | Efficacy analyses as originally described in the protocol were not conducted because of the low number of participants enrolled. | ||
| SECONDARY | Percentage of Participants With Complete Cytogenetic Response | At 6 and 12 months from baseline | Efficacy analyses as originally described in the protocol were not conducted because of the low number of participants enrolled. | ||
| SECONDARY | Median Time to Treatment Failure | Randomization to disease progression, death, or discontinuation (to 12 months) | Efficacy analyses as originally described in the protocol were not conducted because of the low number of participants enrolled. | ||
| SECONDARY | Median Time to Progression-free Survival | Randomization to disease progression or death (to 12 months) | Efficacy analyses as originally described in the protocol were not conducted because of the low number of participants enrolled. |
Source ClinicalTrials.gov
Results by group44
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Death as Outcome, Adverse Events (AEs), Treatment-related AEs, Serious Adverse Events (SAEs), Treatment-related SAEs, and AEs Leading to Discontinuation | Dasatinib, 100 mg | Deaths | 0 | Percentage of participants | |
| Percentage of Participants With Death as Outcome, Adverse Events (AEs), Treatment-related AEs, Serious Adverse Events (SAEs), Treatment-related SAEs, and AEs Leading to Discontinuation | Imatinib, 800 mg | Deaths | 0 | Percentage of participants | |
| Percentage of Participants With Death as Outcome, Adverse Events (AEs), Treatment-related AEs, Serious Adverse Events (SAEs), Treatment-related SAEs, and AEs Leading to Discontinuation | Dasatinib, 100 mg | AEs | 94.7 | Percentage of participants | |
| Percentage of Participants With Death as Outcome, Adverse Events (AEs), Treatment-related AEs, Serious Adverse Events (SAEs), Treatment-related SAEs, and AEs Leading to Discontinuation | Imatinib, 800 mg | AEs | 92.3 | Percentage of participants | |
| Percentage of Participants With Death as Outcome, Adverse Events (AEs), Treatment-related AEs, Serious Adverse Events (SAEs), Treatment-related SAEs, and AEs Leading to Discontinuation | Dasatinib, 100 mg | Treatment-related AEs | 78.9 | Percentage of participants | |
| Percentage of Participants With Death as Outcome, Adverse Events (AEs), Treatment-related AEs, Serious Adverse Events (SAEs), Treatment-related SAEs, and AEs Leading to Discontinuation | Imatinib, 800 mg | Treatment-related AEs | 92.3 | Percentage of participants | |
| Percentage of Participants With Death as Outcome, Adverse Events (AEs), Treatment-related AEs, Serious Adverse Events (SAEs), Treatment-related SAEs, and AEs Leading to Discontinuation | Dasatinib, 100 mg | SAEs | 15.8 | Percentage of participants | |
| Percentage of Participants With Death as Outcome, Adverse Events (AEs), Treatment-related AEs, Serious Adverse Events (SAEs), Treatment-related SAEs, and AEs Leading to Discontinuation | Imatinib, 800 mg | SAEs | 7.7 | Percentage of participants | |
| Percentage of Participants With Death as Outcome, Adverse Events (AEs), Treatment-related AEs, Serious Adverse Events (SAEs), Treatment-related SAEs, and AEs Leading to Discontinuation | Dasatinib, 100 mg | Treatment-related SAEs | 5.3 | Percentage of participants | |
| Percentage of Participants With Death as Outcome, Adverse Events (AEs), Treatment-related AEs, Serious Adverse Events (SAEs), Treatment-related SAEs, and AEs Leading to Discontinuation | Imatinib, 800 mg | Treatment-related SAEs | 7.7 | Percentage of participants |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| First 12 Months | STARTED | Dasatinib, 100 mg | 19 | |
| First 12 Months | STARTED | Imatinib, 800 mg | 13 | |
| First 12 Months | COMPLETED | Dasatinib, 100 mg | 11 | |
| First 12 Months | COMPLETED | Imatinib, 800 mg | 3 | |
| First 12 Months | NOT COMPLETED | Dasatinib, 100 mg | 8 | |
| First 12 Months | NOT COMPLETED | Imatinib, 800 mg | 10 | |
| Long-term (12-month) Extension | STARTED | Dasatinib, 100 mg | 11 | |
| Long-term (12-month) Extension | STARTED | Imatinib, 800 mg | 3 | |
| Long-term (12-month) Extension | COMPLETED | Dasatinib, 100 mg | 2 | |
| Long-term (12-month) Extension | COMPLETED | Imatinib, 800 mg | 1 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events270
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 | EYE PAIN | Eye disorders | Dasatinib, 100 mg | 1 | 19 | |
| other | EYE PAIN | Eye disorders | Imatinib, 800 mg | 0 | 13 | |
| other | EYE SWELLING | Eye disorders | Dasatinib, 100 mg | 0 | 19 | |
| other | EYE SWELLING | Eye disorders | Imatinib, 800 mg | 1 | 13 | |
| other | EYE DISCHARGE | Eye disorders | Dasatinib, 100 mg | 1 | 19 | |
| other | EYE DISCHARGE | Eye disorders | Imatinib, 800 mg | 0 | 13 | |
| other | EYELID OEDEMA | Eye disorders | Dasatinib, 100 mg | 0 | 19 | |
| other | EYELID OEDEMA | Eye disorders | Imatinib, 800 mg | 1 | 13 | |
| other | CONJUNCTIVITIS | Eye disorders | Dasatinib, 100 mg | 0 | 19 | |
| other | CONJUNCTIVITIS | Eye disorders | Imatinib, 800 mg | 2 | 13 |
1 to 10 of 270Source ClinicalTrials.gov
See all 270 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dasatinib, 100 mg | ||
| Total, all-cause mortality | Imatinib, 800 mg | ||
| Total, other adverse events | Dasatinib, 100 mg | 18 | 19 |
| Total, other adverse events | Imatinib, 800 mg | 12 | 13 |
| Total, serious adverse events | Dasatinib, 100 mg | 3 | 19 |
| Total, serious adverse events | Imatinib, 800 mg | 1 | 13 |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Dasatinib, 100 mg vs Imatinib, 800 mg: serious adverse events |
Source 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.
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