Trial · NCT00362466
A Study of Dasatinib vs. High-Dose Imatinib (600 mg) in Patients With Chronic Phase Chronic Myeloid Leukemia (CML) Who Failed to Achieve Complete Cytogenetic Response After 3-18 Months of Imatinib Therapy
NCT00362466, Phase 3, Terminated, Bristol-Myers Squibb; results first posted 2009-09-03
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of Dasatinib vs. High-Dose Imatinib (600 mg) in Patients With Chronic Phase Chronic Myeloid Leukemia (CML) Who Failed to Achieve Complete Cytogenetic Response After 3-18 Months of Imatinib Therapy. Trials, record NCT00362466. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00362466
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
A Study of Dasatinib vs. High-Dose Imatinib (600 mg) in Patients With Chronic Phase Chronic Myeloid Leukemia (CML) Who Failed to Achieve Complete Cytogenetic Response After 3-18 Months of Imatinib Therapy
- NCT number
- NCT00362466
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 3 participants, actual
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- Leukemia
- Interventions
- Dasatinib, Imatinib
- First posted
- 2006-08-10
- Last updated
- 2009-11-20
- Results first posted
- 2009-09-03
- Limitations and caveats
- Study was terminated early due to insufficient enrollment.
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Complete Cytogenetic Response (CCyR) Rate at Month 6 | Month 6 | Cytogenetic Response (CyR) is based on the prevalence of Philadelphia chromosome positive (Ph+) metaphases among cells in metaphase on a bone marrow sample. The criteria for CCyR is 0% Ph+ metaphases among cells in a bone marrow sample. |
| Secondary | Major Molecular Response (MMR) Rates | Month 3, Month 6, Month 12, Month 24 and Month 36 | MMR is defined as a 3-log reduction in BCR-ABL gene transcripts from a standardized baseline. Reductions in BCR-ABL transcripts on logarithmic scale are calculated based on the absolute values expressed as percent of ratio of BCR-ABL gene transcripts to the control gene. In this study,ABL was used as the control gene. |
| Secondary | CCyR Rates | Month 3, Month 12, Month 24 and Month 36 | CyR is based on the prevalence of Ph+ metaphases among cells in metaphase on a bone marrow sample. The criteria for CCyR is 0% Ph+ metaphases among cells in a bone marrow sample. |
| Secondary | Estimate Time to MMR and CCyR | throughout the study | Time to MMR is defined as the time from first treatment dose until measurement criteria are first met for MMR. Time to MMR is computed only for subjects who achieved a MMR. Time to CCyR is defined as the time from first treatment dose until measurement criteria are first met for CCyR. Time to CCyR is computed only for subjects who achieved a CCyR. |
| Secondary | Progression Free Survival (PFS) | at 36 months | PFS=time from randomization until progression or death. Participants who died without progression=progression on date of death. Participants who neither progressed nor died were censored on date of last hematologic assessment. Participants who did not receive study treatment and neither progressed nor died were censored on date of randomization. |
| Secondary | Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to AEs | From 2 weeks prior to randomization through Month 36. At least every 4 weeks until all study-related toxicities resolve to baseline, stabilize, or are deemed irreversible. | An AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a patient or clinical investigation subject administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. An SAE is 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. |
| Secondary | Duration of CCyR and MMR | Throughout the study | Duration of CCyR computed for subjects with CCyR as best response; measured from time the criteria are first met for CCyR until date of progression or death. Duration of MMR computed for subjects with MMR as best response; measured from time the criteria are first met for MMR until date the MMR was first lost, disease progression or death. |
| Secondary | Best MMR Rates | throughout study | MMR is defined as a 3-log reduction in BCR-ABL gene transcripts from a standardized baseline. Reductions in BCR-ABL transcripts on logarithmic scale are calculated based on the absolute values expressed as % of ratio of BCR-ABL gene transcripts to the control gene. In this study, ABL was used as the control gene. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Complete Cytogenetic Response (CCyR) Rate at Month 6 | Month 6 | This analysis was not done. This study was terminated due to insufficient enrollment. | participants | NUMBER |
| SECONDARY | Major Molecular Response (MMR) Rates | Month 3, Month 6, Month 12, Month 24 and Month 36 | This analysis was not done. This study was terminated due to insufficient enrollment. | participants | NUMBER |
| SECONDARY | CCyR Rates | Month 3, Month 12, Month 24 and Month 36 | This analysis was not done. This study was terminated due to insufficient enrollment. | Participants | NUMBER |
| SECONDARY | Estimate Time to MMR and CCyR | throughout the study | This analysis was not done. This study was terminated due to insufficient enrollment. | months | NUMBER |
| SECONDARY | Progression Free Survival (PFS) | at 36 months | This analysis was not done. This study was terminated due to insufficient enrollment. | participants | NUMBER |
| SECONDARY | Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to AEs | From 2 weeks prior to randomization through Month 36. At least every 4 weeks until all study-related toxicities resolve to baseline, stabilize, or are deemed irreversible. | All treated participants | events | NUMBER |
| SECONDARY | Duration of CCyR and MMR | Throughout the study | This analysis was not done. This study was terminated due to insufficient enrollment. | months | NUMBER |
| SECONDARY | Best MMR Rates | throughout study | This analysis was not done. This study was terminated due to insufficient enrollment. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to AEs | Dasatinib | AEs | 3 | events | |
| Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to AEs | Imatinib | AEs | 1 | events | |
| Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to AEs | Dasatinib | SAEs | 0 | events | |
| Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to AEs | Imatinib | SAEs | 0 | events | |
| Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to AEs | Dasatinib | AEs leading to Discontinuation | 0 | events | |
| Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to AEs | Imatinib | AEs leading to Discontinuation | 0 | events | |
| Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to AEs | Dasatinib | Deaths | 0 | events | |
| Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to AEs | Imatinib | Deaths | 0 | events |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dasatinib | 2 | |
| Overall Study | STARTED | Imatinib | 1 | |
| Overall Study | COMPLETED | Dasatinib | 2 | |
| Overall Study | COMPLETED | Imatinib | 1 | |
| Overall Study | NOT COMPLETED | Dasatinib | 0 | |
| Overall Study | NOT COMPLETED | Imatinib | 0 |
Source ClinicalTrials.gov
Adverse events8
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 | Rash | Skin and subcutaneous tissue disorders | Dasatinib | 1 | 2 | |
| other | Rash | Skin and subcutaneous tissue disorders | Imatinib | 0 | 1 | |
| other | Neutropenia | Blood and lymphatic system disorders | Dasatinib | 1 | 2 | |
| other | Neutropenia | Blood and lymphatic system disorders | Imatinib | 0 | 1 | |
| other | Headache | Nervous system disorders | Dasatinib | 1 | 2 | |
| other | Headache | Nervous system disorders | Imatinib | 0 | 1 | |
| other | Hypokalemia | Investigations | Dasatinib | 0 | 2 | |
| other | Hypokalemia | Investigations | Imatinib | 1 | 1 |
Source ClinicalTrials.gov
Adverse 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 | 2 | 2 |
| Total, other adverse events | Imatinib | 1 | 1 |
| Total, serious adverse events | Dasatinib | 0 | 2 |
| Total, serious adverse events | Imatinib | 0 | 1 |
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 vs Imatinib: 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.
GET https://conductscience.org/api/trials/v1/NCT00362466
GET https://conductscience.org/api/trials/v1/NCT00362466/registered