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Trial Summary

Protocol No.PHO-COG-FALLON-AAML1031
StatusOPEN TO ACCRUAL
Principal InvestigatorPradhan, Kamnesh
ScopeNational
PhasePhase III
Age GroupChildren
TitleAAML1031, A Phase III Randomized Trial for Patients with de novo AML using Bortezomib (IND# 58443, NSC# 681239) and Sorafenib (BAY 43-9006, IND#69896, NSC# 724772) for Patients with High Allelic Ratio FLT3/ITD
DescriptionThis 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.
Key EligibilityIn order to be eligible to take part in this trial, patients must meet the following criteria:

  • Be 29 years of age or younger
  • Be newly diagnosed with de novo acute myelogenous leukemia
  • Patients with previously untreated primary AML who meet the customary criteria for AML with >= 20% bone marrow blasts as set out in the 2008 World Health Organization (WHO) Myeloid Neoplasm Classification are eligible
For a full list of participation criteria, please visit clinicaltrials.gov.
Applicable Disease SitesLeukemia (Child)
Participating InstitutionsIndiana University (IU)
  • Indiana University Hospital / IU Simon Cancer Center
  • Riley Hospital for Children
Treatment TypeTreatment
ContactMelissa Lee, Phone: 317-944-4281
Pager: 312-1228
Email: mellee@iu.edu