AAML1031: This phase III trial is evaluating bortezomib (a chemotherapy drug) and sorafenib tosylate (another type of drug) for the treatment of newly diagnosed Acute Myeloid Leukaemia (AML)A Phase III Randomized Trial for Patients With de Novo AML Using Bortezomib and Sorafenib for Patients With High Allelic Ratio FLT3/ITD

Inclusion

• Patients must 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

  • Attempts to obtain bone marrow either by aspirate or biopsy must be made unless clinically prohibitive; in cases where it is clinically prohibitive, peripheral blood with an excess of 20% blasts and in which adequate flow cytometric and cytogenetics/fluorescent in situ hybridization (FISH) testing is feasible can be substituted for the marrow exam at diagnosis

• Patients with < 20% bone marrow blasts are eligible if they have:

  • A karyotypic abnormality characteristic of de novo AML (t(8;21)(q22;q22), inv(16)(p13q22) or t(16;16)(p13;q22) or 11q23 abnormalities
  • The unequivocal presence of megakaryoblasts, or
  • Biopsy proven isolated myeloid sarcoma (myeloblastoma; chloroma, including leukemia cutis)
• Patients with any performance status are eligible for enrollment
• Prior therapy with hydroxyurea, all-trans retinoic acid (ATRA), corticosteroids (any route), and IT cytarabine given at diagnosis is allowed; hydroxyurea and ATRA must be discontinued prior to initiation of protocol therapy; patients who have previously received any other chemotherapy, radiation therapy or any other antileukemic therapy are not eligible for this protocol