Trial · NCT01460160
Pediatric Philadelphia Positive Acute Lymphoblastic Leukemia
NCT01460160, Phase 2, Completed, Bristol-Myers Squibb; results first posted 2018-08-21
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Pediatric Philadelphia Positive Acute Lymphoblastic Leukemia. Trials, record NCT01460160. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01460160
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pediatric Philadelphia Positive Acute Lymphoblastic Leukemia
- NCT number
- NCT01460160
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 106 participants, actual
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- Leukemia, Pediatric
- Interventions
- Dasatinib
- First posted
- 2011-10-26
- Last updated
- 2021-12-08
- Other registries' IDs
- eudract:2011-001123-20
- Results first posted
- 2018-08-21
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 3-year Event-free Survival (EFS) Rate | From first dose to 3 years following first dose | 3-year EFS rate is defined as the percentage of participants without event after 3 years since the start of study treatment. Events for EFS are defined as ANY first one of the following: * Lack of complete response in bone marrow * Relapse at any site * Development of second malignant neoplasm * Death from any cause |
| Secondary | Number of Participants Experiencing Adverse Events | From first dose to 100 days following last dose (up to approximately 23 months) | Number of participants experiencing different types of all causality all grade adverse events |
| Secondary | Event-Free Survival (EFS) Rate (Kaplan-Meier Estimates) | From first dose to 3 years or 5 years following first dose | Overall estimation of the EFS of dasatinib plus chemotherapy was performed utilizing the Kaplan-Meier (KM) Product Limit method. The 3-year and 5-year EFS rates were computed with the corresponding 95% CI's using Greenwood's formula. Analyses of EFS included KM plots with number of patients at risk. Participants who neither relapse nor die or who are lost to follow-up were censored on the date of their last bone marrow, CSF assessment or physical exam, whichever occurred last. |
| Secondary | Complete Remission Rate | From first dose to End of Induction Period Ia (up to 5 weeks) or Ib (up to 9 weeks) or End of Consolidation Period (up to 22 weeks) | Complete Remission rate is defined as the percentage of participants achieving a complete remission, i.e. \< 5% lymphoblasts in bone marrow and in CSF, with no evidence of other extramedullary disease. Complete remission will be assessed at the end of Induction IA, end of induction IB and end of the consolidation period for all treated participants. |
| Secondary | Percentage of Participants Negative for Minimal Residual Disease (MRD) | From first dose to End of Induction Period Ia (up to 5 weeks) or Ib (up to 9 weeks) or End of Consolidation Period (up to 22 weeks) | MRD was by real-time qPCR for clone-specific immunoglobulin and T-cell receptor gene rearrangements (IG/TCR). Participants were declared as MRD negative if the MRD level is undetectable providing the assay lower limit of quantification is at least 0.1% |
| Secondary | Percentage of Participants With BCR-ABL Mutations at Baseline and at Time of Disease Progression or Relapse | At baseline (prior to start of study treatment) and at disease progression or relapse (up to approximately 3 years) | A BCR-ABL mutation is defined as the presence of a detectable amino acid substitution in the ABL kinase domain, assessed by Real-time quantitative PCR. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 3-year Event-free Survival (EFS) Rate | From first dose to 3 years following first dose | All treated partcipants | Percentage of Participants | NUMBER |
| SECONDARY | Number of Participants Experiencing Adverse Events | From first dose to 100 days following last dose (up to approximately 23 months) | All treated participants | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Event-Free Survival (EFS) Rate (Kaplan-Meier Estimates) | From first dose to 3 years or 5 years following first dose | All treated participants | Percentage of Participants | NUMBER |
| SECONDARY | Complete Remission Rate | From first dose to End of Induction Period Ia (up to 5 weeks) or Ib (up to 9 weeks) or End of Consolidation Period (up to 22 weeks) | All treated participants | Percentage of Partcipants | NUMBER |
| SECONDARY | Percentage of Participants Negative for Minimal Residual Disease (MRD) | From first dose to End of Induction Period Ia (up to 5 weeks) or Ib (up to 9 weeks) or End of Consolidation Period (up to 22 weeks) | All treated participants | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With BCR-ABL Mutations at Baseline and at Time of Disease Progression or Relapse | At baseline (prior to start of study treatment) and at disease progression or relapse (up to approximately 3 years) | All treated participants with available measurements | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 3-year Event-free Survival (EFS) Rate | Dasatinib Cohort | 66.0 | 90% Confidence Interval 57.7 to 73.7 | Percentage of Participants | |
| Number of Participants Experiencing Adverse Events | Dasatinib Cohort | Adverse Events (AEs) | 106 | Participants | |
| Number of Participants Experiencing Adverse Events | Dasatinib Cohort | Drug-related AEs | 88 | Participants | |
| Number of Participants Experiencing Adverse Events | Dasatinib Cohort | AEs leading to discontinuation | 7 | Participants | |
| Number of Participants Experiencing Adverse Events | Dasatinib Cohort | Serious Adverse Events (SAEs) | 101 | Participants | |
| Number of Participants Experiencing Adverse Events | Dasatinib Cohort | Deaths | 15 | Participants | |
| Event-Free Survival (EFS) Rate (Kaplan-Meier Estimates) | Dasatinib Cohort | 3-year EFS Estimate | 65.5 | 95% Confidence Interval 55.5 to 73.7 | Percentage of Participants |
| Event-Free Survival (EFS) Rate (Kaplan-Meier Estimates) | Dasatinib Cohort | 5-year EFS Estimate | 53.1 | 95% Confidence Interval 42.8 to 62.3 | Percentage of Participants |
| Complete Remission Rate | Dasatinib Cohort | End of Induction period Ia | 65.1 | Percentage of Partcipants | |
| Complete Remission Rate | Dasatinib Cohort | End of Induction period Ib | 88.7 | Percentage of Partcipants |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment Phase | STARTED | Dasatinib Cohort | 106 | |
| Treatment Phase | COMPLETED | Dasatinib Cohort | 78 | |
| Treatment Phase | NOT COMPLETED | Dasatinib Cohort | 28 | |
| Follow-up Phase | STARTED | Dasatinib Cohort | 100 | |
| Follow-up Phase | COMPLETED | Dasatinib Cohort | 0 | |
| Follow-up Phase | NOT COMPLETED | Dasatinib Cohort | 100 |
Source ClinicalTrials.gov
Adverse events383
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 Cohort | 83 | 106 | |
| other | FEBRILE NEUTROPENIA | Blood and lymphatic system disorders | Dasatinib Cohort | 37 | 106 | |
| other | LEUKOPENIA | Blood and lymphatic system disorders | Dasatinib Cohort | 12 | 106 | |
| other | NEUTROPENIA | Blood and lymphatic system disorders | Dasatinib Cohort | 43 | 106 | |
| other | THROMBOCYTOPENIA | Blood and lymphatic system disorders | Dasatinib Cohort | 50 | 106 | |
| other | PERICARDIAL EFFUSION | Cardiac disorders | Dasatinib Cohort | 6 | 106 | |
| other | SINUS TACHYCARDIA | Cardiac disorders | Dasatinib Cohort | 19 | 106 | |
| other | TACHYCARDIA | Cardiac disorders | Dasatinib Cohort | 35 | 106 | |
| other | EAR PAIN | Ear and labyrinth disorders | Dasatinib Cohort | 25 | 106 | |
| other | EYE PAIN | Eye disorders | Dasatinib Cohort | 8 | 106 |
1 to 10 of 383Source ClinicalTrials.gov
See all 383 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dasatinib Cohort | 21 | 106 |
| Total, other adverse events | Dasatinib Cohort | 106 | 106 |
| Total, serious adverse events | Dasatinib Cohort | 101 | 106 |
Source ClinicalTrials.gov
Papers2
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/NCT01460160
GET https://conductscience.org/api/trials/v1/NCT01460160/events?page=2