Decitabine With or Without Bortezomib in Treating Older Patients With Acute Myeloid Leukemia
Condition: Acute Myeloid Leukemia; Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome; Therapy-Related Acute Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Myelodysplastic Syndromes
Intervention: Bortezomib; Decitabine; Laboratory Biomarker Analysis; Pharmacological Study; Quality-of-Life Assessment; Questionnaire Administration
Intervention description: Given SC; Given IV; Correlative studies; Correlative studies; Ancillary studies; Ancillary studies
Intervention MeSH terms: Bortezomib; Decitabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 165.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: No

Summary:

      This randomized phase II trial studies how well giving decitabine with or without bortezomib
      works in treating older patients with acute myeloid leukemia. Drugs used in chemotherapy,
      such as decitabine, work in different ways to stop the growth of cancer cells, either by
      killing the cells,by stopping them from dividing, or by stopping them from spreading.
      Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for
      cell growth. It is not yet known whether decitabine works better when given with or without
      bortezomib in treating acute myeloid leukemia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Unequivocal pathologic diagnosis of AML (>= 20% blasts in the bone marrow based on
             World Health Organization [WHO] criteria) EXCLUDING:

               -  Acute promyelocytic leukemia t(15;17)(q22;q12); PML-RARA

               -  Acute myeloid leukemia with t(8;21)(q22;q22); RUNX1-RUNXT1 as determined by the
                  Ohio State University (OSU) Molecular Reference Laboratory, per Cancer and
                  Leukemia Group B (CALGB) 20202; however patients who (1) are >= 75 years; and/or
                  (2) have an ejection fraction of < 40%; and/or (3) have a performance status of >
                  2, may be registered to CALGB 20202 and registered and treated on CALGB 11002
                  prior to receiving the FLT3 mutation and core-binding factor (CBF) molecular
                  screening results from CALGB 20202

               -  Acute myeloid leukemia with inv(16)(p13.1;q22) or t(16;16)(p13.1;q22); CBFB-MYH11
                  as determined by the OSU Molecular Reference Laboratory, per CALGB 20202; however
                  patients who (1) are >= 75 years; and/or (2) have an ejection fraction of < 40%;
                  and/or (3) have a performance status of > 2, may be registered to CALGB 20202 and
                  registered and treated on CALGB 11002 prior to receiving the FLT3 mutation and
                  CBF molecular screening results from CALGB 20202

          -  Absence of FLT3 mutation (ITD or point mutation) determined by the OSU Molecular
             Reference Laboratory, per CALGB 20202; however patients who (1) are >= 75 years;
             and/or (2) have an ejection fraction of < 40%; and/or (3) have a performance status of
             > 2, may be registered to CALGB 20202 and registered and treated on CALGB 11002 prior
             to receiving the FLT3 mutation and CBF molecular screening results from CALGB 20202

          -  No prior treatment for AML except:

               -  Emergency leukapheresis

               -  Emergency treatment for hyperleukocytosis with hydroxyurea

               -  Cranial radiotherapy (RT) for central nervous system (CNS) leukostasis (one dose
                  only)

               -  Growth factor/cytokine support

          -  AML patients with an antecedent hematologic disorder (AHD) or myelodysplastic syndrome
             (MDS) are eligible for this trial provided that they have not received treatment for
             their AHD or MDS with cytotoxic chemotherapy (e.g., cytarabine, daunorubicin, etc.),
             decitabine, or bortezomib; patients may have been previously treated with azacitidine
             if their last dose was >= 90 days prior to starting 11002

          -  AML patients with therapy-related myeloid neoplasms (t-MN) are eligible if they have
             not received radiation therapy or chemotherapy (not including hormonal therapy) for
             their primary malignancy or disorder for > 6 months