Bortezomib in Treating Patients With High-Risk Acute Myeloid Leukemia in Remission

This is an interventional treatment trial for Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome Read More

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