Trial · NCT00777036
A Phase II Study of Dasatinib in Children and Adolescents With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia (CML) or With Ph+ Leukemias Resistant or Intolerant to Imatinib
NCT00777036, Phase 2, Completed, Bristol-Myers Squibb; results first posted 2018-01-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Phase II Study of Dasatinib in Children and Adolescents With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia (CML) or With Ph+ Leukemias Resistant or Intolerant to Imatinib. Trials, record NCT00777036. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00777036
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase II Study of Dasatinib in Children and Adolescents With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia (CML) or With Ph+ Leukemias Resistant or Intolerant to Imatinib
- NCT number
- NCT00777036
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 133 participants, actual
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- Leukemia
- Interventions
- Dasatinib
- First posted
- 2008-10-22
- Last updated
- 2025-08-29
- Other registries' IDs
- eudract:2008-002260-33
- Results first posted
- 2018-01-05
Source ClinicalTrials.gov
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Major Cytogenetic Response (MCyR) Rate | From first dose of study therapy until 30 days after last dose (Assessed up to September 2016, approximately 90 months) | Major Cytogenetic Response (MCyR) rate is defined as the proportion of all treated participants who achieved a complete (0%) or partial (1%-35% Ph+ metaphases in at least 20 metaphases in bone marrow) cytogenetic response, expressed as percentage. The denominator of the MCyR response rate consists of all treated participants in Cohort 1, and the numerator is all participants in Cohort 1 achieving MCyR. 95% confidence interval was calculated by Clopper-Pearson exact method. |
| Primary | Complete Hematologic Response (CHR) Rate | From first dose of study therapy until 30 days after last dose (Assessed up to September 2016, approximately 90 months) | Complete Hematologic Response (CHR) rate is defined as the proportion of all treated participants who achieve a confirmed CHR while on-study, expressed as percentage. CHR is defined as including no more than 5% blasts in bone marrow and normal white blood cell count without blasts in peripheral blood, expressed as percentage. The denominator of the CHR response rate consists of all treated participants in Cohort 2, and the numerator is all participants in Cohort 2 achieving CHR. 95% confidence interval was calculated by Clopper-Pearson exact method. |
| Primary | Complete Cytogenetic Response (CCyR) Rate | From first dose of study therapy until 30 days after last dose (Assessed up to September 2016, approximately 90 months) | Complete Cytogenetic Response (CCyR) rate is defined as the proportion of all treated participants who achieve a CCyR while on-study, expressed as a percentage. CCyR rate is defined as 0% Ph+ metaphases in at least 20 metaphases in bone marrow. The denominator of the CCyR response rate consists of all treated participants in Cohort 3, and the numerator is all participants in Cohort 3 achieving CCyR. 95% confidence interval was calculated by Clopper-Pearson exact method. |
| Secondary | Major Cytogenetic Response (MCyR) Rate in Cohort 2 | From first dose of study therapy until 30 days after last dose (Assessed up to September 2016, approximately 90 months) | Major Cytogenetic Response (MCyR) rate was defined as the proportion of all treated participants who achieved a complete (0%) or partial (1%-35% Ph+ metaphases in at least 20 metaphases in bone marrow) cytogenetic response. The percentage of treated participants in each arm with MCyR is reported. |
| Secondary | Complete Hematologic Response (CHR) Rate in Cohorts 1 and 3 | From first dose of study therapy until 30 days after last dose (Assessed up to September 2016, approximately 90 months) | Complete Hematologic Response (CHR) rate defined as the proportion of all treated participants who achieve a confirmed CHR while on-study. CHR is defined as including no more than 5% blasts in bone marrow and normal white blood cell count without blasts in peripheral blood. The percentage of treated participants in each arm with CHR is reported. |
| Secondary | Rate of Best Cytogenetic Response | From first dose of study therapy until 30 days after last dose (Assessed up to September 2016, approximately 90 months) | The number of participants achieving their best on-study cytogenetic response was reported as a percentage of all treated participants in that arm. (Based on \>=20 Metaphases) |
| Secondary | Time to Major Cytogenetic Response (MCyR) | From first dose until MCyR criteria are met (assessed up to September 2016, approximately 90 months) | Time to MCyR is defined as the time from first dose of dasatinib until the first day MCyR criteria are met, computed only for participants whose best response is MCyR. (Based on \>=20 Metaphases) |
| Secondary | Duration of Major Cytogenetic Response (MCyR) | From first day criteria are met for MCyR until the date PD is reported or death (assessed up to September 2016, approximately 90 months) | Duration of MCyR will be computed from the first day criteria are met for MCyR until the date progressive disease (PD) is reported (or treatment is discontinued for PD) or death. Participants who neither discontinue due to PD nor die will be censored on the date of their last hematologic or cytogenetic assessment, whichever comes last. (Based on \>=20 Metaphases) |
| Secondary | Time to Complete Cytogenetic Response (CCyR) | From first dose until CCyR criteria are met, assessed up to September 2016 (approximately 90 months) | Time to CCyR is defined as the time from first dose of dasatinib until the first day CCyR criteria are met, computed only for participants whose best response is CCyR. (Based on \>=20 Metaphases) |
| Secondary | Duration of Complete Cytogenetic Response (CCyR) | From first day criteria are met for CCyR until the date of progressive disease or death (assessed up to September 2016, approximately 90 months) | Duration of CCyR will be computed from the first day criteria are met for CCyR until the date progressive disease (PD) is reported (or treatment is discontinued for PD) or death. Participants who neither discontinue due to PD nor die will be censored on the date of their last hematologic or cytogenetic assessment, whichever comes last. (Based on \>=20 Metaphases) |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 registered outcomesOutcomes21
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Major Cytogenetic Response (MCyR) Rate | From first dose of study therapy until 30 days after last dose (Assessed up to September 2016, approximately 90 months) | Primary efficacy endpoint pre-specified only for participants treated in Cohort 1 | percentage of participants | NUMBER |
| PRIMARY | Complete Hematologic Response (CHR) Rate | From first dose of study therapy until 30 days after last dose (Assessed up to September 2016, approximately 90 months) | Primary efficacy endpoint pre-specified only for participants treated in Cohort 2 | percentage of participants | NUMBER |
| PRIMARY | Complete Cytogenetic Response (CCyR) Rate | From first dose of study therapy until 30 days after last dose (Assessed up to September 2016, approximately 90 months) | Primary efficacy endpoint pre-specified only for participants treated in Cohort 3 | percentage of participants | NUMBER |
| SECONDARY | Major Cytogenetic Response (MCyR) Rate in Cohort 2 | From first dose of study therapy until 30 days after last dose (Assessed up to September 2016, approximately 90 months) | Secondary efficacy endpoint pre-specified only for participants treated in Cohort 2 | percentage of participants | NUMBER |
| SECONDARY | Complete Hematologic Response (CHR) Rate in Cohorts 1 and 3 | From first dose of study therapy until 30 days after last dose (Assessed up to September 2016, approximately 90 months) | Secondary efficacy endpoint pre-specified only for participants treated in Cohort 1 and Cohort 3 | percentage of participants | NUMBER |
| SECONDARY | Rate of Best Cytogenetic Response | From first dose of study therapy until 30 days after last dose (Assessed up to September 2016, approximately 90 months) | All treated participants | percentage of participants | NUMBER |
| SECONDARY | Time to Major Cytogenetic Response (MCyR) | From first dose until MCyR criteria are met (assessed up to September 2016, approximately 90 months) | All treated participants with MCyR | months | MEDIAN |
| SECONDARY | Duration of Major Cytogenetic Response (MCyR) | From first day criteria are met for MCyR until the date PD is reported or death (assessed up to September 2016, approximately 90 months) | All treated participants with MCyR | months | MEDIAN |
| SECONDARY | Time to Complete Cytogenetic Response (CCyR) | From first dose until CCyR criteria are met, assessed up to September 2016 (approximately 90 months) | All treated participants with CCyR | months | MEDIAN |
| SECONDARY | Duration of Complete Cytogenetic Response (CCyR) | From first day criteria are met for CCyR until the date of progressive disease or death (assessed up to September 2016, approximately 90 months) | All treated participants who achieved CCyR | months | MEDIAN |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 outcomesResults by group191
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Major Cytogenetic Response (MCyR) Rate | Cohort 1 | 89.7 | 95% Confidence Interval 72.6 to 97.8 | percentage of participants | |
| Complete Hematologic Response (CHR) Rate | Cohort 2 | 29.4 | 95% Confidence Interval 10.3 to 56.0 | percentage of participants | |
| Complete Cytogenetic Response (CCyR) Rate | Cohort 3 | 94.0 | 95% Confidence Interval 86.7 to 98.0 | percentage of participants | |
| Major Cytogenetic Response (MCyR) Rate in Cohort 2 | Cohort 2 | 52.9 | 95% Confidence Interval 27.8 to 77.0 | percentage of participants | |
| Complete Hematologic Response (CHR) Rate in Cohorts 1 and 3 | Cohort 1 | 93.1 | 95% Confidence Interval 77.2 to 99.2 | percentage of participants | |
| Complete Hematologic Response (CHR) Rate in Cohorts 1 and 3 | Cohort 3 | 96.4 | 95% Confidence Interval 89.9 to 99.3 | percentage of participants | |
| Rate of Best Cytogenetic Response | Cohort 1 | Complete (0%) | 82.8 | percentage of participants | |
| Rate of Best Cytogenetic Response | Cohort 2 | Complete (0%) | 29.4 | percentage of participants | |
| Rate of Best Cytogenetic Response | Cohort 3 | Complete (0%) | 94.0 | percentage of participants | |
| Rate of Best Cytogenetic Response | Cohort 3a | Complete (0%) | 96.1 | percentage of participants |
1 to 10 of 191Source ClinicalTrials.gov
See all 191 results by groupParticipant flow36
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| On Treatment | STARTED | Cohort 1 | 29 | |
| On Treatment | STARTED | Cohort 2 | 17 | |
| On Treatment | STARTED | Cohort 3 | 84 | |
| On Treatment | STARTED | PK Sub-Study | 0 | |
| On Treatment | COMPLETED | Cohort 1 | 0 | |
| On Treatment | COMPLETED | Cohort 2 | 0 | |
| On Treatment | COMPLETED | Cohort 3 | 0 | |
| On Treatment | COMPLETED | PK Sub-Study | 0 | |
| On Treatment | NOT COMPLETED | Cohort 1 | 29 | |
| On Treatment | NOT COMPLETED | Cohort 2 | 17 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 participant flowAdverse events1,770
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 | Cohort 1 | 2 | 29 | |
| other | Anaemia | Blood and lymphatic system disorders | Cohort 2: BP-CML Only | 2 | 8 | |
| other | Anaemia | Blood and lymphatic system disorders | Cohort 2: Ph + ALL Only | 2 | 9 | |
| other | Anaemia | Blood and lymphatic system disorders | Cohort 3a | 11 | 51 | |
| other | Anaemia | Blood and lymphatic system disorders | Cohort 3b | 7 | 33 | |
| other | Anaemia | Blood and lymphatic system disorders | PK Sub-Study | 0 | 7 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Cohort 1 | 0 | 29 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Cohort 2: BP-CML Only | 0 | 8 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Cohort 2: Ph + ALL Only | 1 | 9 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Cohort 3a | 0 | 51 |
1 to 10 of 1,770Source ClinicalTrials.gov
See all 1,770 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1 | 1 | 29 |
| Total, all-cause mortality | Cohort 2: BP-CML Only | 4 | 8 |
| Total, all-cause mortality | Cohort 2: Ph + ALL Only | 7 | 9 |
| Total, all-cause mortality | Cohort 3a | 0 | 51 |
| Total, all-cause mortality | Cohort 3b | 0 | 33 |
| Total, all-cause mortality | PK Sub-Study | 0 | 7 |
| Total, other adverse events | Cohort 1 | 27 | 29 |
| Total, other adverse events | Cohort 2: BP-CML Only | 7 | 8 |
| Total, other adverse events | Cohort 2: Ph + ALL Only | 9 | 9 |
| Total, other adverse events | Cohort 3a | 50 | 51 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers2
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 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/NCT00777036
GET https://conductscience.org/api/trials/v1/NCT00777036/registered?page=2