Bortezomib and Sorafenib Tosylate in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia

Not Recruiting

Trial ID: NCT01371981


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.

Official Title

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

Stanford Investigator(s)


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

   - 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


drug: daunorubicin hydrochloride

drug: asparaginase

drug: mitoxantrone hydrochloride

drug: sorafenib tosylate

drug: cytarabine

drug: etoposide

drug: bortezomib

other: pharmacological study

other: laboratory biomarker analysis

other: questionnaire administration

other: quality-of-life assessment

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305

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