Bortezomib and Sorafenib Tosylate in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia
Condition: Acute Myeloid Leukemia; Leukemia Cutis; Myeloid Neoplasm; Myeloid Sarcoma
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Sarcoma, Myeloid
Intervention: Asparaginase; Bortezomib; Cytarabine; Daunorubicin Hydrochloride; Etoposide; Laboratory Biomarker Analysis; Mitoxantrone Hydrochloride; Pharmacological Study; Quality-of-Life Assessment; Questionnaire Administration; Sorafenib Tosylate
Intervention description: Given IM; Given IV; Given IT or IV; Given IV; Given IV; Correlative studies; Given IV; Correlative studies; Ancillary studies; Ancillary studies; Given PO
Intervention MeSH terms: Cytarabine; Etoposide; Podophyllotoxin; Daunorubicin; Mitoxantrone; Etoposide phosphate; Bortezomib; Sorafenib; Asparaginase
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1645.0
Sex: All
Maximum age: 29 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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

        Exclusion Criteria:

          -  Patients with any of the following constitutional conditions are not eligible:

               -  Fanconi anemia

               -  Shwachman syndrome

               -  Any other known bone marrow failure syndrome

               -  Patients with constitutional trisomy 21 or with constitutional mosaicism of
                  trisomy 21 Note: enrollment may occur pending results of clinically indicated
                  studies to exclude these conditions

          -  Patients with any of the following oncologic diagnoses are not eligible:

               -  Any concurrent malignancy

               -  Juvenile myelomonocytic leukemia (JMML)

               -  Philadelphia chromosome positive AML

               -  Biphenotypic or bilineal acute leukemia

               -  Acute promyelocytic leukemia

               -  Acute myeloid leukemia arising from myelodysplasia

               -  Therapy-related myeloid neoplasms Note: enrollment may occur pending results of
                  clinically indicated studies to exclude these conditions

          -  Pregnancy and breast feeding

          -  Female patients who are pregnant are ineligible

          -  Lactating females are not eligible unless they have agreed not to breastfeed their
             infants

          -  Female patients of childbearing potential are not eligible unless a negative pregnancy
             test result has been obtained

          -  Sexually active patients of reproductive potential are not eligible unless they have
             agreed to use an effective contraceptive method for the duration of their study
             participation