Trial · NCT00049517
Combination Chemotherapy With or Without Monoclonal Antibody Therapy in Treating Patients With AML Leukemia
NCT00049517, Phase 3, Completed, Eastern Cooperative Oncology Group; results first posted 2013-02-12
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Combination Chemotherapy With or Without Monoclonal Antibody Therapy in Treating Patients With AML Leukemia. Trials, record NCT00049517. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00049517
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Combination Chemotherapy With or Without Monoclonal Antibody Therapy in Treating Patients With AML Leukemia
- NCT number
- NCT00049517
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 657 participants, actual
- Lead sponsor
- Eastern Cooperative Oncology Group
- Conditions
- Leukemia
- Interventions
- sargramostim, busulfan, cyclophosphamide, cytarabine, gemtuzumab ozogamicin (GO), Daunorubicin, Autologous HCT, Allogeneic HCT
- First posted
- 2003-01-27
- Last updated
- 2023-06-15
- Results first posted
- 2013-02-12
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival (Induction Phase) | Assessed during the first 4 months, then at least every three months for 2 years. then every six months until 5 years after study entry and every 12 months thereafter. | Overall survival is defined as the time from randomization in the induction phase to death. |
| Primary | Disease-free Survival (Consolidation Phase) | Assessed during the first 4 months, then at least every three months for 2 years. then every six months until five years after study entry, and every 12 months thereafter. | Disease-free survival is defined from the time of the confirmation of a complete remission via biopsy to the relapse of the disease. |
| Secondary | Overall Survival (Consolidation Phase) | Assessed during the first 4 months, then at least every three months for 2 years. then every six months until five years after study entry, and every 12 months thereafter. | Overall survival is defined as the time from randomization in the consolidation phase to death. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival (Induction Phase) | Assessed during the first 4 months, then at least every three months for 2 years. then every six months until 5 years after study entry and every 12 months thereafter. | All randomized patients are included in the analysis (intention-to-treat). | months | MEDIAN |
| PRIMARY | Disease-free Survival (Consolidation Phase) | Assessed during the first 4 months, then at least every three months for 2 years. then every six months until five years after study entry, and every 12 months thereafter. | Only 270 patients who were randomized in the consolidation phase are included in the analysis. | Months | MEDIAN |
| SECONDARY | Overall Survival (Consolidation Phase) | Assessed during the first 4 months, then at least every three months for 2 years. then every six months until five years after study entry, and every 12 months thereafter. | Only 270 patients who were randomized in the consolidation phase are included in the analysis. | Months | MEDIAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival (Induction Phase) | Standard Daunorubicin | 15.7 | 95% Confidence Interval 12.7 to 19.0 | months | |
| Overall Survival (Induction Phase) | High-dose Daunorubicin | 23.7 | 95% Confidence Interval 19.0 to 31.7 | months | |
| Disease-free Survival (Consolidation Phase) | Autologous HCT | 15.0 | 95% Confidence Interval 11.4 to 23.9 | Months | |
| Disease-free Survival (Consolidation Phase) | Go/Autologous HCT | 13.6 | 95% Confidence Interval 10.7 to 18.4 | Months | |
| Overall Survival (Consolidation Phase) | Autologous HCT | 35.5 | 95% Confidence Interval 24.2 to 51.7 | Months | |
| Overall Survival (Consolidation Phase) | Go/Autologous HCT | 27.9 | 95% Confidence Interval 20.3 to 39.5 | Months |
Source ClinicalTrials.gov
Participant flow48
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Induction | STARTED | Standard Daunorubicin Then Autologous HCT | 79 | |
| Induction | STARTED | High-dose Daunorubicin Then Autologous HCT | 90 | |
| Induction | STARTED | Standard Daunorubicin Then GO/Autologous HCT | 63 | |
| Induction | STARTED | High-dose Daunorubicin Then GO/Autologous HCT | 75 | |
| Induction | STARTED | Standard Daunorubicin Then Allogeneic HCT or no Consolidation | 188 | |
| Induction | STARTED | High-dose Daunorubicin Then Allogeneic HCT or no Consolidation | 162 | |
| Induction | Treated | Standard Daunorubicin Then Autologous HCT | 79 | |
| Induction | Treated | High-dose Daunorubicin Then Autologous HCT | 90 | |
| Induction | Treated | Standard Daunorubicin Then GO/Autologous HCT | 63 | |
| Induction | Treated | High-dose Daunorubicin Then GO/Autologous HCT | 75 |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 participant flowAdverse events264
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 | Standard Daunorubicin (Induction Therapy) | 319 | 328 | |
| other | Anemia | Blood and lymphatic system disorders | High Dose Daunorubicin (Induction Therapy) | 318 | 325 | |
| other | Leukopenia | Blood and lymphatic system disorders | Standard Daunorubicin (Induction Therapy) | 281 | 328 | |
| other | Leukopenia | Blood and lymphatic system disorders | High Dose Daunorubicin (Induction Therapy) | 267 | 325 | |
| other | Neutropenia | Blood and lymphatic system disorders | Standard Daunorubicin (Induction Therapy) | 243 | 328 | |
| other | Neutropenia | Blood and lymphatic system disorders | High Dose Daunorubicin (Induction Therapy) | 230 | 325 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Standard Daunorubicin (Induction Therapy) | 295 | 328 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | High Dose Daunorubicin (Induction Therapy) | 292 | 325 | |
| other | Nausea | General disorders | Standard Daunorubicin (Induction Therapy) | 16 | 328 | |
| other | Nausea | General disorders | High Dose Daunorubicin (Induction Therapy) | 18 | 325 |
1 to 10 of 264Source ClinicalTrials.gov
See all 264 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Standard Daunorubicin (Induction Therapy) | ||
| Total, all-cause mortality | High Dose Daunorubicin (Induction Therapy) | ||
| Total, other adverse events | Standard Daunorubicin (Induction Therapy) | 319 | 328 |
| Total, other adverse events | High Dose Daunorubicin (Induction Therapy) | 318 | 325 |
| Total, serious adverse events | Standard Daunorubicin (Induction Therapy) | 328 | 328 |
| Total, serious adverse events | High Dose Daunorubicin (Induction Therapy) | 325 | 325 |
Source ClinicalTrials.gov
Papers10
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 |
|---|---|---|---|---|---|
| U10CA021115 | Eastern Cooperative Oncology Group Operations Office | COMIS, ROBERT L | FRONTIER SCI & TECHNOLOGY RSCH FDN, INC | NATIONAL CANCER INSTITUTE | 1985 to 2013 |
Source NIH RePORTER
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Standard Daunorubicin (Induction Therapy) vs High Dose Daunorubicin (Induction Therapy): 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/NCT00049517
GET https://conductscience.org/api/trials/v1/NCT00049517/flow?page=2