Clinical Trial COGAAML1031


AAML1031 - 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

Principal Investigator(s)

Haydar Frangoul


  • Protocol No. COGAAML1031
  • Open Date: 08/24/2011
  • Staging: Phase III
  • Age Group: Children
  • Scope: National
  • Objective: 1.1.1 To compare event free survival (EFS) and overall survival (OS) in patients with de novo acute myeloid leukemia (AML) without high allelic ratio FLT3/ITD+ mutations who are randomized to standard therapy versus bortezomib/standard combination therapy. 1.1.2 To determine the feasibility of combining bortezomib with standard chemotherapy in patients with de novo AML. 1.1.3 To compare the OS and EFS of high risk patients treated with intensive Induction II with historical controls from AAML03P1 and AAML0531. 1.1.4 To determine the feasibility of combining sorafenib with standard chemotherapy in patients with de novo high allelic ratio FLT3/ITD+ AML.
  • Disease Sites: Pediatrics; Pediatric Leukemia
  • Therapies: Chemotherapy - cytotoxic; Molecular Targeted Agents / Immunotherapy / Biologics
  • Drugs: BAY 43-9006 (Sorafenib); Bortezomib (BTZ); Cytarabine (ARA-C); Daunorubicin (Daunomycin); Etoposide; Sorafenib (Nexavar); VELCADE
  • Participating Institutions: Vanderbilt University
  • National Clinical Trial ID: NCT01371981
  • Secondary Protocol No: Not Specified



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