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Type(s) of Cancer
Leukemia/Lymphoma,Sarcoma
Study Phase
Phase 3
Study Completion Date
March 2019
NCT01371981Uploaded 03-24-2021
Access via NCI by Request
PDS UID: nci-data-461
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
Provider Information
Provider Data DescriptionNCT01371981 ? D4 Dataset As of April 2020, there is one dataset associated with this publication (PMID 32029509). The D4 dataset is a patient level dataset which contains patient characteristics, consort diagram classifications, toxicity and outcome analyses in the manuscript for eligible pediatric acute myeloid leukemia (AML) patients enrolled on the AAML1031 clinical trial.
SponsorNational Cancer Institute (NCI)
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis 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.
ConditionsAcute Myeloid Leukemia
Leukemia Cutis
Myeloid Neoplasm
Myeloid Sarcoma
Intervention TypeDrug: Asparaginase
Drug: Bortezomib
Drug: Cytarabine
Drug: Daunorubicin Hydrochloride
Drug: Etoposide
Other: Laboratory Biomarker Analysis
Drug: Mitoxantrone Hydrochloride
Other: Pharmacological Study
Other: Quality-of-Life Assessment
Other: Questionnaire Administration
Drug: Sorafenib Tosylate
Drug(s)Drug: Asparaginase
Drug: Cytarabine
Drug: Daunorubicin Hydrochloride
Drug: Etoposide
Drug: Mitoxantrone Hydrochloride
Drug: Bortezomib
Drug: Sorafenib Tosylate
Total Enrolled1645
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionArm A - Experimental
Arm B - Experimental
Arm C (Cohort 1) - Experimental
Arm C (Cohort 2) - Experimental
Arm C (Cohort 3) - Experimental
Arm D - Experimental
Secondary IDNCI-2011-02670
PubMed (PMID)35349331
34855461
34596937
32029509
30987448
30773463
28419486
Collaborator(s)N/A
Region(s)United States
Australia
Canada
New Zealand
Puerto Rico
Age Range29 Years and younger (Child, Adult)
Files: NCT01371981-D4
Data DictionaryNCT01371981-D4-Data-Dictionary_1.pdf
DATANCT01371981-D4-Dataset.csv
OTHERREADME.pdf
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