Trial · NCT00720109
Dasatinib and Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
NCT00720109, Phase 2, Phase 3, Completed, National Cancer Institute (NCI); results first posted 2016-10-07
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Dasatinib and Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Lymphoblastic Leukemia. Trials, record NCT00720109. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00720109
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Dasatinib and Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
- NCT number
- NCT00720109
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 63 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Acute Lymphoblastic Leukemia, Adult B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1, Childhood B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1
- Interventions
Asparaginase, Cyclophosphamide, Cytarabine, Dasatinib, Daunorubicin Hydrochloride, Dexamethasone, Etoposide, Filgrastim, Hydrocortisone Sodium Succinate, Ifosfamide, Laboratory Biomarker Analysis, Leucovorin Calcium, Mercaptopurine, Methotrexate, Methylprednisolone, Pegaspargase, Prednisone, Radiation Therapy, Vincristine Sulfate
- First posted
- 2008-07-22
- Last updated
- 2020-04-13
- Results first posted
- 2016-10-07
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Event-Free Survival (EFS) of Patients With Standard-risk Disease Treated With Dasatinib in Combination With Intensified Chemotherapy | At 3 years | Event-Free Survival (EFS) curves will be constructed using the Kaplan-Meier life table method with standard errors computed using the method of Peto and Peto. A 1-sided 95% confidence interval for EFS will be constructed. |
| Primary | Feasibility and Toxicity of an Intensified Chemotherapeutic Regimen Incorporating Dasatinib for Treatment of Children and Adolescents With Ph+ ALL Assessed by Examining Adverse Events | Weeks 3 through 23 of treatment (From week 3 Induction through Intensification Block 1) | Number of patients in safety cohort with dose limiting toxicity (DLT)(including treatment delay) |
| Secondary | Contribution of Dasatinib on Minimal Residual Disease (MRD) After Induction Therapy | At the end of induction therapy (at 5 weeks) | Percent of patients MRD Positive (MRD \> 0.01%) at End of Induction. |
| Secondary | Percent of Patients MRD Positive (MRD > 0.01%) at End of Consolidation | At end of consolidation (at 11 weeks) | A 1-sample Z-test of proportions (alpha=5%, 1-sided test) will be used. |
| Secondary | Overall EFS Rate for the Combined Cohort of Standard- and High-Risk Patients (Who Receive the Final Chosen Dose of Dasatinib) | From the time entry on study to first event or date of last follow-up, assessed up to 7 years | An event is defined as: Induction failure, relapse at any site, secondary malignancy, or death. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Event-Free Survival (EFS) of Patients With Standard-risk Disease Treated With Dasatinib in Combination With Intensified Chemotherapy | At 3 years | Patients with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia (ALL). | Percent probability | NUMBER |
| PRIMARY | Feasibility and Toxicity of an Intensified Chemotherapeutic Regimen Incorporating Dasatinib for Treatment of Children and Adolescents With Ph+ ALL Assessed by Examining Adverse Events | Weeks 3 through 23 of treatment (From week 3 Induction through Intensification Block 1) | Patients with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia (ALL) | Pts with DLTs | NUMBER |
| SECONDARY | Contribution of Dasatinib on Minimal Residual Disease (MRD) After Induction Therapy | At the end of induction therapy (at 5 weeks) | Patients with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia (ALL). | Percentage of participants | NUMBER |
| SECONDARY | Percent of Patients MRD Positive (MRD > 0.01%) at End of Consolidation | At end of consolidation (at 11 weeks) | Patients with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia (ALL). | Percentage of participants | NUMBER |
| SECONDARY | Overall EFS Rate for the Combined Cohort of Standard- and High-Risk Patients (Who Receive the Final Chosen Dose of Dasatinib) | From the time entry on study to first event or date of last follow-up, assessed up to 7 years | Included in the analysis are two patients who received the drug therapy but were not risk classified. | percentage of patients | NUMBER |
Source ClinicalTrials.gov
Results by group13
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Event-Free Survival (EFS) of Patients With Standard-risk Disease Treated With Dasatinib in Combination With Intensified Chemotherapy | Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy) | 79.8 | 90% Confidence Interval 71.1 to 88.5 | Percent probability | |
| Event-Free Survival (EFS) of Patients With Standard-risk Disease Treated With Dasatinib in Combination With Intensified Chemotherapy | Standard-risk | 83.2 | 90% Confidence Interval 74.1 to 92.2 | Percent probability | |
| Event-Free Survival (EFS) of Patients With Standard-risk Disease Treated With Dasatinib in Combination With Intensified Chemotherapy | High-risk | 66.7 | 90% Confidence Interval 40.9 to 92.5 | Percent probability | |
| Feasibility and Toxicity of an Intensified Chemotherapeutic Regimen Incorporating Dasatinib for Treatment of Children and Adolescents With Ph+ ALL Assessed by Examining Adverse Events | Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy) | 1 | Pts with DLTs | ||
| Contribution of Dasatinib on Minimal Residual Disease (MRD) After Induction Therapy | Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy) | 40.7 | 90% Confidence Interval 30.8 to 51.4 | Percentage of participants | |
| Contribution of Dasatinib on Minimal Residual Disease (MRD) After Induction Therapy | Standard-risk | 29.2 | 90% Confidence Interval 19.7 to 40.9 | Percentage of participants | |
| Contribution of Dasatinib on Minimal Residual Disease (MRD) After Induction Therapy | High-risk | 100.0 | 90% Confidence Interval 73.1 to 100.0 | Percentage of participants | |
| Percent of Patients MRD Positive (MRD > 0.01%) at End of Consolidation | Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy) | 10.5 | 90% Confidence Interval 5.3 to 19.3 | Percentage of participants | |
| Percent of Patients MRD Positive (MRD > 0.01%) at End of Consolidation | Standard-risk | 0 | 90% Confidence Interval 0.0 to 6.4 | Percentage of participants | |
| Percent of Patients MRD Positive (MRD > 0.01%) at End of Consolidation | High-risk | 66.7 | 90% Confidence Interval 39.6 to 96.1 | Percentage of participants |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Induction Period | STARTED | Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy) | 63 | |
| Induction Period | STARTED | Standard-risk | 0 | |
| Induction Period | STARTED | High-risk | 0 | |
| Induction Period | COMPLETED | Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy) | 57 | |
| Induction Period | COMPLETED | Standard-risk | 0 | |
| Induction Period | COMPLETED | High-risk | 0 | |
| Induction Period | NOT COMPLETED | Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy) | 6 | |
| Induction Period | NOT COMPLETED | Standard-risk | 0 | |
| Induction Period | NOT COMPLETED | High-risk | 0 | |
| Risk Stratification Period | STARTED | Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy) | 0 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events603
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 | Abdominal pain | Gastrointestinal disorders | Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy) | 7 | 60 | 7 |
| other | Abdominal pain | Gastrointestinal disorders | Standard-risk | 7 | 48 | 7 |
| other | Abdominal pain | Gastrointestinal disorders | High-risk | 0 | 9 | 0 |
| other | Acidosis | Metabolism and nutrition disorders | Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy) | 1 | 60 | 1 |
| other | Acidosis | Metabolism and nutrition disorders | Standard-risk | 1 | 48 | 1 |
| other | Acidosis | Metabolism and nutrition disorders | High-risk | 0 | 9 | 0 |
| other | Acoustic nerve disorder NOS | Nervous system disorders | Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy) | 1 | 60 | 1 |
| other | Acoustic nerve disorder NOS | Nervous system disorders | Standard-risk | 1 | 48 | 1 |
| other | Acoustic nerve disorder NOS | Nervous system disorders | High-risk | 0 | 9 | 0 |
| other | Activated partial thromboplastin time prolonged | Investigations | Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy) | 2 | 60 | 2 |
1 to 10 of 603Source ClinicalTrials.gov
See all 603 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy) | ||
| Total, all-cause mortality | Standard-risk | ||
| Total, all-cause mortality | High-risk | ||
| Total, other adverse events | Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy) | 59 | 60 |
| Total, other adverse events | Standard-risk | 48 | 48 |
| Total, other adverse events | High-risk | 8 | 9 |
| Total, serious adverse events | Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy) | 36 | 60 |
| Total, serious adverse events | Standard-risk | 28 | 48 |
| Total, serious adverse events | High-risk | 7 | 9 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U10CA098543 | Children's Oncology Group Chair's Grant | ADAMSON, PETER C. | CHILDREN'S HOSP OF PHILADELPHIA | NATIONAL CANCER INSTITUTE | 2003 to 2013 |
Source NIH RePORTER
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/NCT00720109
GET https://conductscience.org/api/trials/v1/NCT00720109/events?page=2