Trial · NCT01371981
Bortezomib and Sorafenib Tosylate in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia
NCT01371981, Phase 3, Completed, National Cancer Institute (NCI); results first posted 2020-07-07
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Bortezomib and Sorafenib Tosylate in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia. Trials, record NCT01371981. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01371981
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Bortezomib and Sorafenib Tosylate in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia
- NCT number
- NCT01371981
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,645 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Acute Myeloid Leukemia, Leukemia Cutis, Myeloid Neoplasm, Myeloid Sarcoma
- Interventions
Asparaginase, Bortezomib, Cytarabine, Daunorubicin Hydrochloride, Etoposide, Laboratory Biomarker Analysis, Mitoxantrone Hydrochloride, Pharmacological Study, Quality-of-Life Assessment, Questionnaire Administration, Sorafenib Tosylate
- First posted
- 2011-06-13
- Last updated
- 2026-06-02
- Results first posted
- 2020-07-07
Source ClinicalTrials.gov
Registered outcomes25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Event-free Survival (EFS) for Patients Without High Allelic Ratio FLT3/ITD+ Mutations | Up to 3 years | The Kaplan-Meier method will be used to estimate 3-year EFS, defined as the time from study entry until induction failure, relapse, secondary malignancy, or death. |
| Primary | EFS for Patients on Arm C, Cohort 1 | Up to 3 years | The Kaplan-Meier method will be used to estimate 3-year EFS, defined as the time from study entry until induction failure, relapse, secondary malignancy, or death. |
| Primary | EFS for Patients on Arm C, Cohort 2 | Up to 3 years | The Kaplan-Meier method will be used to estimate 3-year EFS, defined as the time from study entry until induction failure, relapse, secondary malignancy, or death. |
| Primary | EFS for Patients on Arm C, Cohort 3 | Up to 3 years | The Kaplan-Meier method will be used to estimate 3-year EFS, defined as the time from study entry until induction failure, relapse, secondary malignancy, or death. |
| Secondary | Overall Survival (OS) for Patients Without High Allelic Ratio FLT3/ITD+ Mutations | Up to 3 years | The Kaplan-Meier method will be used to estimate 3-year OS, defined as the time from study entry until death. |
| Secondary | OS for Patients on Arm C, Cohort 1 | Up to 3 years | The Kaplan-Meier method will be used to estimate 3-year OS, defined as the time from study entry until death. |
| Secondary | OS for Patients on Arm C, Cohort 2 | Up to 3 years | The Kaplan-Meier method will be used to estimate 3-year OS, defined as the time from study entry until death. |
| Secondary | OS for Patients on Arm C, Cohort 3 | Up to 3 years | The Kaplan-Meier method will be used to estimate 3-year OS, defined as the time from study entry until death. |
| Secondary | Relapse Rate for Patients Without High Allelic Ratio FLT3/ITD+ Mutations | Up to 3 years | Cumulative incidence estimates 3 year relapse rate defined as time from study entry to induction failure or relapse where deaths or secondary malignancies are competing events. |
| Secondary | Proportion of Patients Experiencing Grade 3 or Higher Non-hematologic Toxicities and Infections While on Protocol Therapy | Up to 2 years | The proportion of patients experiencing at least one grade 3 or higher non-hematologic toxicity and infection while on protocol therapy will be estimated along with the corresponding 95% confidence interval determined using a binomial exact method. Toxicity will be assessed by Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0). |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 registered outcomesOutcomes25
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) for Patients Without High Allelic Ratio FLT3/ITD+ Mutations | Up to 3 years | Patients ineligible, did not start treatment, or on Arm D are excluded from analyses of EFS. Arm D patients who were not eligible for Arm C by the end of induction I were declared off study per protocol; thus, no outcome data were collected for Arm D patients. Arms A and B are limited to patients without high allelic ratio FLT3/ITD+ mutations. | percentage of patients | NUMBER |
| PRIMARY | EFS for Patients on Arm C, Cohort 1 | Up to 3 years | Patients ineligible, did not start treatment, or on Arm D are excluded from analyses of EFS. Arm D patients who were not eligible for Arm C by the end of induction I were declared off study per protocol; thus, no outcome data were collected for Arm D patients. | percentage of patients | NUMBER |
| PRIMARY | EFS for Patients on Arm C, Cohort 2 | Up to 3 years | Patients ineligible, did not start treatment, or on Arm D are excluded from analyses of EFS. Arm D patients who were not eligible for Arm C by the end of induction I were declared off study per protocol; thus, no outcome data were collected for Arm D patients. | percentage of patients | NUMBER |
| PRIMARY | EFS for Patients on Arm C, Cohort 3 | Up to 3 years | Patients ineligible, did not start treatment, or on Arm D are excluded from analyses of EFS. Arm D patients who were not eligible for Arm C by the end of induction I were declared off study per protocol; thus, no outcome data were collected for Arm D patients. | percentage of patients | NUMBER |
| SECONDARY | Overall Survival (OS) for Patients Without High Allelic Ratio FLT3/ITD+ Mutations | Up to 3 years | Patients ineligible, did not start treatment, or on Arm D are excluded from analyses of OS. Arm D patients who were not eligible for Arm C by the end of induction I were declared off study per protocol; thus, no outcome data were collected for Arm D patients. Arms A and B are limited to patients without high allelic ratio FLT3/ITD+ mutations. | percentage of patients | NUMBER |
| SECONDARY | OS for Patients on Arm C, Cohort 1 | Up to 3 years | Patients ineligible, did not start treatment, or on Arm D are excluded from analyses of OS. Arm D patients who were not eligible for Arm C by the end of induction I were declared off study per protocol; thus, no outcome data were collected for Arm D patients. | percentage of patients | NUMBER |
| SECONDARY | OS for Patients on Arm C, Cohort 2 | Up to 3 years | Patients ineligible, did not start treatment, or on Arm D are excluded from analyses of OS. Arm D patients who were not eligible for Arm C by the end of induction I were declared off study per protocol; thus, no outcome data were collected for Arm D patients. | percentage of patients | NUMBER |
| SECONDARY | OS for Patients on Arm C, Cohort 3 | Up to 3 years | Patients ineligible, did not start treatment, or on Arm D are excluded from analyses of OS. Arm D patients who were not eligible for Arm C by the end of induction I were declared off study per protocol; thus, no outcome data were collected for Arm D patients. | percentage of patients | NUMBER |
| SECONDARY | Relapse Rate for Patients Without High Allelic Ratio FLT3/ITD+ Mutations | Up to 3 years | Patients ineligible, did not start treatment, or on Arms C or D are excluded. Arm D patients who were not eligible for Arm C by the end of induction I were declared off study per protocol; thus, no outcome data were collected for Arm D patients. Results are limited to patients on Arms A and B without high allelic ratio FLT3/ITD+ mutations. | percentage of patients | NUMBER |
| SECONDARY | Proportion of Patients Experiencing Grade 3 or Higher Non-hematologic Toxicities and Infections While on Protocol Therapy | Up to 2 years | Patients ineligible or who did not start treatment are excluded from results. | Proportion of patients | NUMBER |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 outcomesResults by group44
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) for Patients Without High Allelic Ratio FLT3/ITD+ Mutations | Arm A | 45.64 | 95% Confidence Interval 41.34 to 49.83 | percentage of patients | |
| Event-free Survival (EFS) for Patients Without High Allelic Ratio FLT3/ITD+ Mutations | Arm B | 46.95 | 95% Confidence Interval 42.69 to 51.09 | percentage of patients | |
| EFS for Patients on Arm C, Cohort 1 | Arm C (Cohort 1) | 25.00 | 95% Confidence Interval 6.01 to 50.48 | percentage of patients | |
| EFS for Patients on Arm C, Cohort 2 | Arm C (Cohort 2) | 56.12 | 95% Confidence Interval 37.33 to 71.28 | percentage of patients | |
| EFS for Patients on Arm C, Cohort 3 | Arm C (Cohort 3) | 58.18 | 95% Confidence Interval 42.30 to 71.11 | percentage of patients | |
| Overall Survival (OS) for Patients Without High Allelic Ratio FLT3/ITD+ Mutations | Arm A | 65.04 | 95% Confidence Interval 60.75 to 68.98 | percentage of patients | |
| Overall Survival (OS) for Patients Without High Allelic Ratio FLT3/ITD+ Mutations | Arm B | 68.45 | 95% Confidence Interval 64.33 to 72.21 | percentage of patients | |
| OS for Patients on Arm C, Cohort 1 | Arm C (Cohort 1) | 41.67 | 95% Confidence Interval 15.25 to 66.53 | percentage of patients | |
| OS for Patients on Arm C, Cohort 2 | Arm C (Cohort 2) | 64.77 | 95% Confidence Interval 45.37 to 78.77 | percentage of patients | |
| OS for Patients on Arm C, Cohort 3 | Arm C (Cohort 3) | 61.84 | 95% Confidence Interval 44.09 to 75.42 | percentage of patients |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm A | 580 | |
| Overall Study | STARTED | Arm B | 591 | |
| Overall Study | STARTED | Arm C (Cohort 1) | 12 | |
| Overall Study | STARTED | Arm C (Cohort 2) | 33 | |
| Overall Study | STARTED | Arm C (Cohort 3) | 47 | |
| Overall Study | STARTED | Arm D | 382 | |
| Overall Study | COMPLETED | Arm A | 396 | |
| Overall Study | COMPLETED | Arm B | 399 | |
| Overall Study | COMPLETED | Arm C (Cohort 1) | 6 | |
| Overall Study | COMPLETED | Arm C (Cohort 2) | 12 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events3,102
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 | Arm A | 4 | 559 | |
| other | Anemia | Blood and lymphatic system disorders | Arm B | 5 | 575 | |
| other | Anemia | Blood and lymphatic system disorders | Arm C (Cohort 1) | 0 | 12 | |
| other | Anemia | Blood and lymphatic system disorders | Arm C (Cohort 2) | 0 | 33 | |
| other | Anemia | Blood and lymphatic system disorders | Arm C (Cohort 3) | 1 | 47 | |
| other | Anemia | Blood and lymphatic system disorders | Arm D | 0 | 376 | |
| other | Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | Arm A | 3 | 559 | |
| other | Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | Arm B | 1 | 575 | |
| other | Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | Arm C (Cohort 1) | 0 | 12 | |
| other | Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | Arm C (Cohort 2) | 1 | 33 |
1 to 10 of 3,102Source ClinicalTrials.gov
See all 3,102 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm A | 198 | 559 |
| Total, all-cause mortality | Arm B | 189 | 575 |
| Total, all-cause mortality | Arm C (Cohort 1) | 7 | 12 |
| Total, all-cause mortality | Arm C (Cohort 2) | 11 | 33 |
| Total, all-cause mortality | Arm C (Cohort 3) | 16 | 47 |
| Total, all-cause mortality | Arm D | 2 | 376 |
| Total, other adverse events | Arm A | 506 | 559 |
| Total, other adverse events | Arm B | 529 | 575 |
| Total, other adverse events | Arm C (Cohort 1) | 12 | 12 |
| Total, other adverse events | Arm C (Cohort 2) | 32 | 33 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers12
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 |
|---|---|---|---|---|---|---|
| U10CA180886 | COG NCTN Network Group Operations Center | Hawkins, Douglas S. | COG RESEARCH FOUNDATION, LLC | NATIONAL CANCER INSTITUTE | 2014 to 2026 | NIH RePORTER |
| U10CA098543 | Children's Oncology Group Chair's Grant | ADAMSON, PETER C. | CHILDREN'S HOSP OF PHILADELPHIA | NATIONAL CANCER INSTITUTE | 2003 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/NCT01371981
GET https://conductscience.org/api/trials/v1/NCT01371981/registered?page=2