Trial · NCT00651261
Daunorubicin, Cytarabine, and Midostaurin in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia
NCT00651261, Phase 3, Completed, Alliance for Clinical Trials in Oncology; results first posted 2017-02-06
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Daunorubicin, Cytarabine, and Midostaurin in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia. Trials, record NCT00651261. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00651261
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Daunorubicin, Cytarabine, and Midostaurin in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia
- NCT number
- NCT00651261
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 717 participants, actual
- Lead sponsor
- Alliance for Clinical Trials in Oncology
- Conditions
- Leukemia
- Interventions
- cytarabine, daunorubicin, midostaurin, placebo, dexamethasone acetate
- First posted
- 2008-04-02
- Last updated
- 2026-10-21
- Other registries' IDs
- eudract:2006-006852-37
- Results first posted
- 2017-02-06
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival (OS) | Duration of study (Up to 10 years) | Overall survival (OS) was defined as the time interval from randomization to death from any cause. The median OS with 95% CI was estimated using the Kaplan-Meier method. |
| Secondary | Event- Free Survival | Duration of study (Up to 10 years) | Event free survival (EFS) was defined as the time from randomization until the earliest qualifying event, including: failure to obtain a CR on or before 60 days of initiation of protocol therapy; relapse; or death from any cause. Patients alive and event free at the time of analysis were censored on the date of last clinical assessment. The median EFS with 95% CI was estimated using the Kaplan-Meier method. Due to a higher than expected transplant rate, EFS was promoted to be a key secondary endpoint. |
| Secondary | Overall Survival, Censoring Participants Who Receive a Stem Cell Transplant at the Time of the Transplant | Duration of study (Up to 10 years) | Overall survival (OS) was defined as the time interval from randomization to death from any cause. Any participants who received a stem cell transplant were censored at the time of transplant. The median OS with 95% CI was estimated using the Kaplan-Meier method. |
| Secondary | Complete Response Rate | Induction therapy (up to 60 days) | Percentage of participants who achieved a complete response (CR). A CR was defined as normalization of blood counts and a marrow showing less than 5% blasts occurring on or before day 60. |
| Secondary | Disease-free Survival (DFS) | Duration of study (Up to 10 years) | Disease free survival (DFS) is defined as the time from documentation of first CR at any time to the first of relapse or death from any cause in participants who achieved a CR. |
| Secondary | DFS Rate One Year After Completing the Planned Continuation Phase | 30 months |
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 | Overall Survival (OS) | Duration of study (Up to 10 years) | months | MEDIAN | |
| SECONDARY | Event- Free Survival | Duration of study (Up to 10 years) | months | MEDIAN | |
| SECONDARY | Overall Survival, Censoring Participants Who Receive a Stem Cell Transplant at the Time of the Transplant | Duration of study (Up to 10 years) | months | MEDIAN | |
| SECONDARY | Complete Response Rate | Induction therapy (up to 60 days) | percentage of participants | NUMBER | |
| SECONDARY | Disease-free Survival (DFS) | Duration of study (Up to 10 years) | months | MEDIAN | |
| SECONDARY | DFS Rate One Year After Completing the Planned Continuation Phase | 30 months |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival (OS) | Induction and Consolidation Chemotherapy Plus Midostaurin | 74.7 | 95% Confidence Interval 31.5 to NA | months | |
| Overall Survival (OS) | Induction and Consolidation Chemotherapy Plus Placebo | 25.6 | 95% Confidence Interval 18.6 to 42.9 | months | |
| Event- Free Survival | Induction and Consolidation Chemotherapy Plus Midostaurin | 8.2 | 95% Confidence Interval 5.4 to 10.7 | months | |
| Event- Free Survival | Induction and Consolidation Chemotherapy Plus Placebo | 3.0 | 95% Confidence Interval 1.9 to 5.9 | months | |
| Overall Survival, Censoring Participants Who Receive a Stem Cell Transplant at the Time of the Transplant | Induction and Consolidation Chemotherapy Plus Midostaurin | NA | 95% Confidence Interval NA to NA | months | |
| Overall Survival, Censoring Participants Who Receive a Stem Cell Transplant at the Time of the Transplant | Induction and Consolidation Chemotherapy Plus Placebo | NA | 95% Confidence Interval 27.4 to NA | months | |
| Complete Response Rate | Induction and Consolidation Chemotherapy Plus Midostaurin | 59 | 95% Confidence Interval 54 to 64 | percentage of participants | |
| Complete Response Rate | Induction and Consolidation Chemotherapy Plus Placebo | 54 | 95% Confidence Interval 48 to 59 | percentage of participants | |
| Disease-free Survival (DFS) | Induction and Consolidation Chemotherapy Plus Midostaurin | 26.7 | 95% Confidence Interval 19.4 to NA | months | |
| Disease-free Survival (DFS) | Induction and Consolidation Chemotherapy Plus Placebo | 15.5 | 95% Confidence Interval 11.3 to 23.5 | months |
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 | Induction and Consolidation Chemotherapy Plus Midostaurin | 360 | |
| Overall Study | STARTED | Induction and Consolidation Chemotherapy Plus Placebo | 357 | |
| Overall Study | COMPLETED | Induction and Consolidation Chemotherapy Plus Midostaurin | 69 | |
| Overall Study | COMPLETED | Induction and Consolidation Chemotherapy Plus Placebo | 51 | |
| Overall Study | NOT COMPLETED | Induction and Consolidation Chemotherapy Plus Midostaurin | 291 | |
| Overall Study | NOT COMPLETED | Induction and Consolidation Chemotherapy Plus Placebo | 306 |
Source ClinicalTrials.gov
Adverse events1,458
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 | Blood disorder | Blood and lymphatic system disorders | Induction and Consolidation Chemotherapy Plus Midostaurin | 5 | 355 | 11 |
| other | Blood disorder | Blood and lymphatic system disorders | Induction and Consolidation Chemotherapy Plus Placebo | 4 | 354 | 6 |
| other | Disseminated intravascular coagulation | Blood and lymphatic system disorders | Induction and Consolidation Chemotherapy Plus Midostaurin | 2 | 355 | 2 |
| other | Disseminated intravascular coagulation | Blood and lymphatic system disorders | Induction and Consolidation Chemotherapy Plus Placebo | 1 | 354 | 1 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Induction and Consolidation Chemotherapy Plus Midostaurin | 246 | 355 | 422 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Induction and Consolidation Chemotherapy Plus Placebo | 238 | 354 | 394 |
| other | Hemoglobin decreased | Blood and lymphatic system disorders | Induction and Consolidation Chemotherapy Plus Midostaurin | 312 | 355 | 1,059 |
| other | Hemoglobin decreased | Blood and lymphatic system disorders | Induction and Consolidation Chemotherapy Plus Placebo | 311 | 354 | 940 |
| other | Lymph node pain | Blood and lymphatic system disorders | Induction and Consolidation Chemotherapy Plus Midostaurin | 2 | 355 | 2 |
| other | Lymph node pain | Blood and lymphatic system disorders | Induction and Consolidation Chemotherapy Plus Placebo | 0 | 354 | 0 |
1 to 10 of 1,458Source ClinicalTrials.gov
See all 1,458 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Induction and Consolidation Chemotherapy Plus Midostaurin | ||
| Total, all-cause mortality | Induction and Consolidation Chemotherapy Plus Placebo | ||
| Total, other adverse events | Induction and Consolidation Chemotherapy Plus Midostaurin | 321 | 355 |
| Total, other adverse events | Induction and Consolidation Chemotherapy Plus Placebo | 324 | 354 |
| Total, serious adverse events | Induction and Consolidation Chemotherapy Plus Midostaurin | 157 | 355 |
| Total, serious adverse events | Induction and Consolidation Chemotherapy Plus Placebo | 154 | 354 |
Source ClinicalTrials.gov
Papers7
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Induction and Consolidation Chemotherapy Plus Midostaurin vs Induction and Consolidation Chemotherapy Plus Placebo: serious adverse events |
Source 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/NCT00651261
GET https://conductscience.org/api/trials/v1/NCT00651261/events?page=2