Trial · NCT01876953
Dasatinib, Cytarabine, and Idarubicin in Treating Patients With High-Risk Acute Myeloid Leukemia
NCT01876953, Phase 1, Phase 2, Terminated, City of Hope Medical Center; results first posted 2021-09-16
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Dasatinib, Cytarabine, and Idarubicin in Treating Patients With High-Risk Acute Myeloid Leukemia. Trials, record NCT01876953. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01876953
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Dasatinib, Cytarabine, and Idarubicin in Treating Patients With High-Risk Acute Myeloid Leukemia
- NCT number
- NCT01876953
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 20 participants, actual
- Lead sponsor
- City of Hope Medical Center
- Conditions
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Del(5q), Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), Adult Acute Myeloid Leukemia With t(15;17)(q22;q12), Adult Acute Myeloid Leukemia With t(16;16)(p13;q22), Adult Acute Myeloid Leukemia With t(8;21)(q22;q22), Recurrent Adult Acute Myeloid Leukemia, Secondary Acute Myeloid Leukemia, Untreated Adult Acute Myeloid Leukemia
- Interventions
- cytarabine, idarubicin, dasatinib, laboratory biomarker analysis
- First posted
- 2013-06-13
- Last updated
- 2022-03-31
- Results first posted
- 2021-09-16
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Tolerated Dose of Dasatinib (Phase I) | From the first dose of Dasatinib through the DLT observation period (Day +28) | Maximum tolerated dose of dasatinib, determined according to incidence of dose limiting toxicity (DLT), graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (Phase I) |
| Primary | Complete Remission Rate (Phase II) | From the first cycle up to two years | Remission rates will be calculated as the percent of evaluable patients that have a confirmed CR, and exact 95% confidence intervals will be calculated for these estimates. |
| Secondary | Overall Survival (Phase II) | Time from start of study therapy until death, or last contact, whichever comes first, assessed up to 2 years | Overall survival was measured from the first dose of Dasatinib to death from any cause or last contact, whichever comes first. It was estimated using the product-limit method of Kaplan and Meier. |
| Secondary | Event-free Survival (Phase II) | Time from start of study therapy until death, relapse/progression, receipt of anti-leukemia therapy, or last contact, whichever comes first, assessed up to two years. | Event-free survival was defined as time from the first dose of Dasatinib to relapse/progression, receipt of anti-leukemia therapy, death, or last contact, whichever comes first. It was estimated using the product-limit method of Kaplan and Meier. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Maximum Tolerated Dose of Dasatinib (Phase I) | From the first dose of Dasatinib through the DLT observation period (Day +28) | Six patients treated at 100 mg/m2 in Phase I are evaluable for dose limiting toxicity. | mg/m2 | NUMBER |
| PRIMARY | Complete Remission Rate (Phase II) | From the first cycle up to two years | The study was terminated before the data were mature enough to estimate the CR rate. Therefore, the overall number of participants who were evaluable is zero. | ||
| SECONDARY | Overall Survival (Phase II) | Time from start of study therapy until death, or last contact, whichever comes first, assessed up to 2 years | The study was terminated before the data were mature enough to estimate the overall survival outcomes. Therefore, the overall number of participants who were evaluable is zero. | ||
| SECONDARY | Event-free Survival (Phase II) | Time from start of study therapy until death, relapse/progression, receipt of anti-leukemia therapy, or last contact, whichever comes first, assessed up to two years. | The study was terminated before the data were mature enough to estimate the even-free survival. Therefore, the overall number of participants who were evaluable is zero. |
Source ClinicalTrials.gov
Results by group1
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Maximum Tolerated Dose of Dasatinib (Phase I) | Dasatinib 100mg/Day + Cytarabine 200mg/m2/Day + Idarubicin 12mg/m2/Day | 100 | mg/m2 |
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 100mg/Day + Cytarabine 200mg/m2/Day + Idarubicin 12mg/m2/Day | 17 | |
| Overall Study | STARTED | Dasatinib 140mg/Day + Cytarabine 200mg/m2/Day + Idarubicin 12mg/m2/Day | 3 | |
| Overall Study | COMPLETED | Dasatinib 100mg/Day + Cytarabine 200mg/m2/Day + Idarubicin 12mg/m2/Day | 17 | |
| Overall Study | COMPLETED | Dasatinib 140mg/Day + Cytarabine 200mg/m2/Day + Idarubicin 12mg/m2/Day | 3 | |
| Overall Study | NOT COMPLETED | Dasatinib 100mg/Day + Cytarabine 200mg/m2/Day + Idarubicin 12mg/m2/Day | 0 | |
| Overall Study | NOT COMPLETED | Dasatinib 140mg/Day + Cytarabine 200mg/m2/Day + Idarubicin 12mg/m2/Day | 0 |
Source ClinicalTrials.gov
Adverse events408
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 | 10002272-Anemia | Blood and lymphatic system disorders | Dasatinib 100mg/Day + Cytarabine 200mg/m2/Day + Idarubicin 12mg/m2/Day | 16 | 17 | 83 |
| other | 10002272-Anemia | Blood and lymphatic system disorders | Dasatinib 140mg/Day + Cytarabine 200mg/m2/Day + Idarubicin 12mg/m2/Day | 3 | 3 | 3 |
| other | 10016288-Febrile neutropenia | Blood and lymphatic system disorders | Dasatinib 100mg/Day + Cytarabine 200mg/m2/Day + Idarubicin 12mg/m2/Day | 5 | 17 | 12 |
| other | 10016288-Febrile neutropenia | Blood and lymphatic system disorders | Dasatinib 140mg/Day + Cytarabine 200mg/m2/Day + Idarubicin 12mg/m2/Day | 0 | 3 | 0 |
| other | Markedly irregular multilobulated spleen with linear calcification | Blood and lymphatic system disorders | Dasatinib 100mg/Day + Cytarabine 200mg/m2/Day + Idarubicin 12mg/m2/Day | 0 | 17 | 0 |
| other | Markedly irregular multilobulated spleen with linear calcification | Blood and lymphatic system disorders | Dasatinib 140mg/Day + Cytarabine 200mg/m2/Day + Idarubicin 12mg/m2/Day | 1 | 3 | 1 |
| other | Splenomegaly | Blood and lymphatic system disorders | Dasatinib 100mg/Day + Cytarabine 200mg/m2/Day + Idarubicin 12mg/m2/Day | 1 | 17 | 1 |
| other | Splenomegaly | Blood and lymphatic system disorders | Dasatinib 140mg/Day + Cytarabine 200mg/m2/Day + Idarubicin 12mg/m2/Day | 0 | 3 | 0 |
| other | 10003658-Atrial fibrillation | Cardiac disorders | Dasatinib 100mg/Day + Cytarabine 200mg/m2/Day + Idarubicin 12mg/m2/Day | 1 | 17 | 1 |
| other | 10003658-Atrial fibrillation | Cardiac disorders | Dasatinib 140mg/Day + Cytarabine 200mg/m2/Day + Idarubicin 12mg/m2/Day | 0 | 3 | 0 |
1 to 10 of 408Source ClinicalTrials.gov
See all 408 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dasatinib 100mg/Day + Cytarabine 200mg/m2/Day + Idarubicin 12mg/m2/Day | 11 | 17 |
| Total, all-cause mortality | Dasatinib 140mg/Day + Cytarabine 200mg/m2/Day + Idarubicin 12mg/m2/Day | 3 | 3 |
| Total, other adverse events | Dasatinib 100mg/Day + Cytarabine 200mg/m2/Day + Idarubicin 12mg/m2/Day | 17 | 17 |
| Total, other adverse events | Dasatinib 140mg/Day + Cytarabine 200mg/m2/Day + Idarubicin 12mg/m2/Day | 3 | 3 |
| Total, serious adverse events | Dasatinib 100mg/Day + Cytarabine 200mg/m2/Day + Idarubicin 12mg/m2/Day | 4 | 17 |
| Total, serious adverse events | Dasatinib 140mg/Day + Cytarabine 200mg/m2/Day + Idarubicin 12mg/m2/Day | 0 | 3 |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Dasatinib 100mg/Day + Cytarabine 200mg/m2/Day + Idarubicin 12mg/m2/Day vs Dasatinib 140mg/Day + Cytarabine 200mg/m2/Day + Idarubicin 12mg/m2/Day: deaths from any cause | Trial comparisons |
| Dasatinib 100mg/Day + Cytarabine 200mg/m2/Day + Idarubicin 12mg/m2/Day vs Dasatinib 140mg/Day + Cytarabine 200mg/m2/Day + Idarubicin 12mg/m2/Day: serious adverse events | 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/NCT01876953
GET https://conductscience.org/api/trials/v1/NCT01876953/events?page=2