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Leukemia

Bortezomib for High-Risk Acute Myeloid Leukemia in Remission
A Phase II Study of Subcutaneous Bortezomib as Maintenance Therapy for Patients With High-risk Acute Myeloid Leukemia in Remission
Status Conditions Phase Study ID
Recruiting Acute Myeloid Leukemia Phase II NCT01465386
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
Investigator
John M. Pagel, MD, PhD
Location    
Seattle Cancer Care Alliance 800-804-8824  
Eligibility Criteria (must meet the following to participate in this study)
  • 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
Exclusions (conditions that would prevent participation in this study)
  • 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
Last Updated
June 05, 2012
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.