Bortezomib in Treating Patients With High-Risk Acute Myeloid Leukemia in Remission
Condition: Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome; Adult Acute Minimally Differentiated Myeloid Leukemia (M0); Adult Acute Myeloblastic Leukemia Without Maturation (M1); Adult Acute Myeloid Leukemia in Remission; Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities; Adult Acute Myeloid Leukemia With Del(5q); Adult Acute Myeloid Leukemia With t(15;17)(q22;q12); Adult Acute Myeloid Leukemia With t(16;16)(p13;q22); Adult Acute Promyelocytic Leukemia (M3); Adult Erythroleukemia (M6a); Adult Pure Erythroid Leukemia (M6b); Secondary Acute Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Leukemia, Promyelocytic, Acute; Leukemia, Erythroblastic, Acute; Myelodysplastic Syndromes
Intervention: bortezomib
Intervention description: Given SC
Intervention MeSH terms: Bortezomib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial studies how well bortezomib works in treating patients with high-risk
      acute myeloid leukemia (AML) in remission. Bortezomib may stop the growth of cancer cells by
      blocking some of the enzymes needed for cell growth
    

Eligibility criteria:

        Inclusion Criteria:

          -  All adults with first remission AML including those with prior myelodysplasia
             (MDS)/AML, therapy-related AML, AML with trilineage dysplasia (AML-TLD), and AML with
             adverse cytogenetics

          -  History of histopathologically documented AML that is currently in first remission
             with the presence of 5% or less blasts by morphology and/or flow cytometry from a bone
             marrow aspirate and/or biopsy obtained within 14 days of enrollment

          -  Patients must start therapy between 3-8 weeks after receiving their last prior therapy
             (either induction therapy or consolidation therapy)

          -  Patients may receive up to 4 courses of remission consolidation therapy (e.g.,
             cytarabine) prior to enrollment

          -  Normal kidney and liver function with serum creatinine =< 2.0 mg/dl

          -  Total bilirubin =< 1.5 upper limit of normal (ULN)

          -  Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x ULN

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2

          -  Male subjects, even if surgically sterilized (i.e., status postvasectomy) must agree
             to 1 of the following: practice effective barrier contraception during the entire
             study treatment period and through a minimum of 30 days after the last dose of study
             drug, or completely abstain from heterosexual intercourse

          -  Female subject is either postmenopausal for at least 1 year before the screening
             visit, is surgically sterilized or if they are of childbearing potential, agree to
             practice 2 effective methods of contraception from the time of signing the informed
             consent form through 30 days after the last dose of bortezomib, or agree to completely
             abstain from heterosexual intercourse

          -  Understand and voluntarily sign the informed consent form for this study

        Exclusion Criteria:

          -  Favorable AML features defined as the following:

               -  t(8;21)(q22;q22); RUNX1-RUNX1T1

               -  inv(16)(p13.1q22) or t(16;16)(p13.1;q22); CBFB-MYH11

               -  Mutated NPM1 without FLT3-ITD (normal karyotype)

               -  Mutated CEBPA (normal karyotype)

          -  Persistent clinically significant non-hematological toxicity that is > Grade 1 by
             National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
             v4 from prior chemotherapy

          -  Active uncontrolled infection

          -  Known infection with human immunodeficiency virus (HIV)

          -  Medical condition, serious concurrent illness, or other extenuating circumstance that,
             in the judgment of the Principal Investigator, could jeopardize patient safety or
             interfere with the objectives of the study

          -  Uncontrolled or significant cardiovascular disease, including:

               -  Uncontrolled angina or myocardial infarction within 6 months

               -  Current or history of congestive heart failure New York Heart Association (NYHA)
                  class 3 or 4, unless a screening echocardiogram (ECHO) or Multiple Gate
                  Acquisition Scan (MUGA) performed within 1 month prior to study screening results
                  in a left ventricular ejection fraction (LVEF) that is >= 45% (or institutional
                  lower limit of normal value)

               -  Prolonged QTc interval (> 450 msec)

          -  Diagnosed or treated for another malignancy within 3 years of enrollment, with the
             exception of complete resection of basal cell carcinoma or squamous cell carcinoma of
             the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy

          -  Patient has a platelet count of < 30,000 within 3 days before enrollment

          -  Patient has an absolute neutrophil count of < 300 within 3 days before enrollment

          -  Patient has >= Grade 2 peripheral neuropathy

          -  Patient has hypersensitivity to bortezomib, boron, or mannitol

          -  Female patients who are lactating or have a positive urine pregnancy test during the
             screening; pregnancy testing is not required for postmenopausal or surgically
             sterilized women

          -  Participation in clinical trials with other investigational agents not included in
             this trial, within 14 days of the start of this trial and throughout the duration of
             this trial