At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 1,645 enrolled / 1,645 target

Drug / intervention

Asparaginase +10 moredrug

Likely dose

Not stated in record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01371981

NCT01371981Phase 3CompletedMonitor (9.2/mo)Completion was 87mo ago

Compare CT.gov

A Phase III Randomized Trial for Patients With De Novo AML Using Bortezomib and Sorafenib (NSC# 681239, NSC# 724772) for Patients With High Allelic Ratio FLT3/ITD

National Cancer Institute (NCI)·interventional·Posted Jun 13, 2011·Updated Jun 2, 2026

In Brief

A Phase 3 clinical trial evaluating Asparaginase, Bortezomib, and 9 other interventions for Acute Myeloid Leukemia and 3 related conditions. Completed, enrolled 1,645 participants across 220 sites in 5 countries.

Signals

Enrolling slower than its timeline implies

Detailed Summary

This randomized phase III trial studies how well bortezomib and sorafenib tosylate work in treating patients with newly diagnosed acute myeloid leukemia. Bortezomib and sorafenib tosylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving bortezomib and sorafenib tosylate together with combination chemotherapy may be an effective treatment for acute myeloid leukemia.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsAcute Myeloid Leukemia, Leukemia Cutis, Myeloid Neoplasm, Myeloid Sarcoma

CountriesAustralia, Canada, New Zealand, Puerto Rico, United States

Collaborators--

Timeline

Phase 3CompletedFinished

201220132014201520162017201820192020202120222023202420252026

First PostedJun 2011

Enrollment StartJul 2011

Primary CompletionMar 2019

Study CompletionMar 2026

TodayJul 2026

First PostedJun 13, 2011

Enrollment StartJul 6, 2011

Primary CompletionMar 31, 2019

Study CompletionMar 31, 2026

TodayJul 2, 2026

Enrollment to primary: 7.7 yearsPosted 15.1 years ago

Arms & Interventions

Arm Aexperimental

See Detailed Description

Drug: AsparaginaseDrug: CytarabineDrug: Daunorubicin HydrochlorideDrug: EtoposideOther: Laboratory Biomarker AnalysisDrug: Mitoxantrone HydrochlorideOther: Pharmacological StudyOther: Quality-of-Life AssessmentOther: Questionnaire Administration

Arm Bexperimental

See Detailed Description

Drug: AsparaginaseDrug: BortezomibDrug: CytarabineDrug: Daunorubicin HydrochlorideDrug: EtoposideOther: Laboratory Biomarker AnalysisDrug: Mitoxantrone HydrochlorideOther: Pharmacological StudyOther: Quality-of-Life AssessmentOther: Questionnaire Administration

Arm C (Cohort 1)experimental

See Detailed Description

Arm C (Cohort 2)experimental

See Detailed Description.

Arm C (Cohort 3)experimental

See Detailed Description. Different dose.

Arm Dexperimental

See Detailed Description. May reassigned to Arm C.

Drug: CytarabineDrug: Daunorubicin HydrochlorideDrug: EtoposideOther: Laboratory Biomarker AnalysisOther: Pharmacological StudyOther: Quality-of-Life AssessmentOther: Questionnaire Administration

Interventions

Asparaginasedrug

Given IM

Bortezomibdrug

Given IV

Cytarabinedrug

Given IT or IV

Daunorubicin Hydrochloridedrug

Given IV

Etoposidedrug

Given IV

Laboratory Biomarker Analysisother

Correlative studies

Mitoxantrone Hydrochloridedrug

Given IV

Pharmacological Studyother

Correlative studies

Quality-of-Life Assessmentother

Ancillary studies

Questionnaire Administrationother

Ancillary studies

Sorafenib Tosylatedrug

Given PO