NCTN: 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 (AAML1031)
Study ID: AAML1031
NCT Number: NCT01371981
Children's Oncology Group (COG)
Submitted in collaboration with the NCTN/NCORP Data Archive
Trial Title: NCTN: 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 (AAML1031)
Trial Description: 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.
Clinical data presented in the following publication(s):
- PMID 32029509
Disease type(s): Hematopoietic Neoplasm/Leukemia - Acute Myeloid Leukemia
Clinical Dataset(s) included:
- NCT01371981-D4 (PMID 32029509): There is one dataset (-D4) for AAML1031's primary publication (PMID 32029509). This dataset is a patient level dataset which contains patient characteristics, consort diagram classifications, abnormal karyotype, CEBP alpha status, NPM status, minimal residual disease, survival, treatment-related mortality, and toxicity data presented in the manuscript for eligible pediatric acute myeloid leukemia (AML) patients enrolled on the AAML1031 clinical trial.
Forthcoming Dataset(s): NCT01371981-D1, NCT01371981-D2, NCT01371981-D3, NCT01371981-D5, NCT01371981-D6
You are encouraged to view the PDF data dictionaries found in the “Documents” tab of the dbGaP study page, which may contain additional information regarding the data or the associated publication(s).
- Type: Interventional
- Archive: The database of Genotypes and Phenotypes (dbGaP)