Trial · NCT01238211
Combination Chemotherapy and Dasatinib in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia
NCT01238211, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2014-08-12
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Combination Chemotherapy and Dasatinib in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia. Trials, record NCT01238211. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01238211
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Combination Chemotherapy and Dasatinib in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia
- NCT number
- NCT01238211
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 61 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome, Adult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11, Adult Acute Myeloid Leukemia With t(16;16)(p13.1;q22); CBFB-MYH11, Adult Acute Myeloid Leukemia With t(8;21); (q22; q22.1); RUNX1-RUNX1T1, Core Binding Factor Acute Myeloid Leukemia, Secondary Acute Myeloid Leukemia, Therapy-Related Acute Myeloid Leukemia
- Interventions
- Cytarabine, Dasatinib, Daunorubicin Hydrochloride, Laboratory Biomarker Analysis
- First posted
- 2010-11-10
- Last updated
- 2023-03-01
- Results first posted
- 2014-08-12
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 30 Day Survival Rate | 30 days | Percentage of participants who were alive 30 days after starting induction treatment. |
| Secondary | Event-free Survival | 1 year | Event free survival (EFS) is defined as the time from registration to failure to achieve complete remission (CR), relapse after CR is attained or death, whichever comes first. The 1 year EFS rate with 95% CI was estimated using the Kaplan-Meier method, Complete remission (CR) is defined as: disappearance of all clinical and/or radiologic evidence of disease. Neutrophil count \> 1.0 x 10\^9/L and platelet count \> 100 x 10\^9/L, and normal bone marrow differential (\< 5% blasts). |
| Secondary | Complete Response Rate | 60 months | Percentage of participants who achieve a CR. Complete remission (CR) is defined as: disappearance of all clinical and/or radiologic evidence of disease. Neutrophil count \> 1.0 x 10\^9/L and platelet count \> 100 x 10\^9/L, and normal bone marrow differential (\< 5% blasts). |
| Secondary | Cumulative Incidence of Relapse | 60 months | |
| Secondary | Cumulative Incidence of Death | 36 months | |
| Secondary | Disease-free Survival | 3 years | Disease free survival (DFS) is defined as the time from achievement of CR to relapse or death, whichever comes first. The 3 year DFS rate with 95% CI was estimated using the Kaplan-Meier method. |
| Secondary | Overall Survival | 3 years | Overall survival (OS) is defined as time from registration to death. The 3 year OS rate with 95% CI was estimated using the Kaplan-Meier method. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 30 Day Survival Rate | 30 days | percentage of participants | NUMBER | |
| SECONDARY | Event-free Survival | 1 year | percentage of patients | NUMBER | |
| SECONDARY | Complete Response Rate | 60 months | percentage of patients | NUMBER | |
| SECONDARY | Cumulative Incidence of Relapse | 60 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Cumulative Incidence of Death | 36 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Disease-free Survival | 3 years | percentage of patients | NUMBER | |
| SECONDARY | Overall Survival | 3 years | percentage of patients | NUMBER |
Source ClinicalTrials.gov
Results by group7
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 30 Day Survival Rate | Treatment (Daunorubicin Hydrochloride, Cytarabine, Dasatinib) | 97 | 95% Confidence Interval 89 to 99.6 | percentage of participants | |
| Event-free Survival | Treatment (Daunorubicin Hydrochloride, Cytarabine, Dasatinib) | 83 | 95% Confidence Interval 70.7 to 90.5 | percentage of patients | |
| Complete Response Rate | Treatment (Daunorubicin Hydrochloride, Cytarabine, Dasatinib) | 90 | 95% Confidence Interval 80 to 96 | percentage of patients | |
| Cumulative Incidence of Relapse | Treatment (Daunorubicin Hydrochloride, Cytarabine, Dasatinib) | 10 | Participants | ||
| Cumulative Incidence of Death | Treatment (Daunorubicin Hydrochloride, Cytarabine, Dasatinib) | 15 | Participants | ||
| Disease-free Survival | Treatment (Daunorubicin Hydrochloride, Cytarabine, Dasatinib) | 75 | 95% Confidence Interval 63 to 89 | percentage of patients | |
| Overall Survival | Treatment (Daunorubicin Hydrochloride, Cytarabine, Dasatinib) | 77 | 95% Confidence Interval 66 to 89 | percentage of patients |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment (Daunorubicin Hydrochloride, Cytarabine, Dasatinib) | 61 | |
| Overall Study | COMPLETED | Treatment (Daunorubicin Hydrochloride, Cytarabine, Dasatinib) | 3 | |
| Overall Study | NOT COMPLETED | Treatment (Daunorubicin Hydrochloride, Cytarabine, Dasatinib) | 58 |
Source ClinicalTrials.gov
Adverse events394
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 | Anemia | Blood and lymphatic system disorders | Treatment (Daunorubicin Hydrochloride, Cytarabine, Dasatinib) | 58 | 61 | |
| other | Blood and lymphatic system disorders - Other | Blood and lymphatic system disorders | Treatment (Daunorubicin Hydrochloride, Cytarabine, Dasatinib) | 5 | 61 | |
| other | Disseminated intravascular coagulation | Blood and lymphatic system disorders | Treatment (Daunorubicin Hydrochloride, Cytarabine, Dasatinib) | 8 | 61 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Treatment (Daunorubicin Hydrochloride, Cytarabine, Dasatinib) | 47 | 61 | |
| other | Leukocytosis | Blood and lymphatic system disorders | Treatment (Daunorubicin Hydrochloride, Cytarabine, Dasatinib) | 6 | 61 | |
| other | Lymph node pain | Blood and lymphatic system disorders | Treatment (Daunorubicin Hydrochloride, Cytarabine, Dasatinib) | 3 | 61 | |
| other | Atrioventricular block first degree | Cardiac disorders | Treatment (Daunorubicin Hydrochloride, Cytarabine, Dasatinib) | 2 | 61 | |
| other | Cardiac disorders - Other | Cardiac disorders | Treatment (Daunorubicin Hydrochloride, Cytarabine, Dasatinib) | 5 | 61 | |
| other | Chest pain - cardiac | Cardiac disorders | Treatment (Daunorubicin Hydrochloride, Cytarabine, Dasatinib) | 2 | 61 | |
| other | Heart failure | Cardiac disorders | Treatment (Daunorubicin Hydrochloride, Cytarabine, Dasatinib) | 3 | 61 |
1 to 10 of 394Source ClinicalTrials.gov
See all 394 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment (Daunorubicin Hydrochloride, Cytarabine, Dasatinib) | 15 | 61 |
| Total, other adverse events | Treatment (Daunorubicin Hydrochloride, Cytarabine, Dasatinib) | 61 | 61 |
| Total, serious adverse events | Treatment (Daunorubicin Hydrochloride, Cytarabine, Dasatinib) | 27 | 61 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants2
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 | Source |
|---|---|---|---|---|---|---|
| U10CA180821 | Alliance for Clinical Trials in Oncology Operations Center | Galanis, Evanthia; Hahn, Olwen; Kozono, David | ALLIANCE NCTN FOUNDATION | NATIONAL CANCER INSTITUTE | 2014 to 2026 | NIH RePORTER |
| U10CA031946 | Cancer and Leukemia Group B | BERTAGNOLLI, MONICA M | BRIGHAM AND WOMEN'S HOSPITAL | NATIONAL CANCER INSTITUTE | 1985 to 2013 | 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/NCT01238211
GET https://conductscience.org/api/trials/v1/NCT01238211/events?page=2