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

• Status: Terminated
• Trial end date: 2015-03-02
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fred Hutchinson Cancer Research Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Bortezomib

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