Decitabine and Bortezomib in Treating Patients With Acute Myeloid Leukemia
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)
About this trial
This is an interventional treatment trial for Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
Eligibility Criteria
Inclusion Criteria:
Diagnosis of acute myeloid leukemia (AML), meeting one of the following criteria:
- Relapsed or refractory disease (≥ 18 years of age)
- Previously untreated disease (≥ 60 years of age)
- Secondary AML or therapy-related AML allowed
- No granulocytic sarcoma as the sole site of disease
- No active or relapsed CNS disease
- No advanced malignant solid tumors
- ECOG performance status 0-2
- Life expectancy > 6 months (if patient has co-morbid illness)
- Total bilirubin < 2.0 mg/dL
- AST and ALT < 2.5 times upper limit of normal
- Creatinine < 2.0 mg/dL
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
Patients with HIV infection are eligible provided the following criteria are met:
- No history of AIDS
- Has a sufficiently high CD4 count (> 400/mm³)
- Has low HIV viral loads (< 30,000 copies/mL plasma)
- Does not require anti-HIV therapy
- No uncontrolled active infection
- No history of allergic reactions attributed to compounds of similar chemical or biological composition to decitabine or bortezomib that are not easily managed
- No hypersensitivity to boron or mannitol
No concurrent uncontrolled illness including, but not limited to, any of the following:
- Symptomatic congestive heart failure
- Unstable or uncontrolled angina pectoris
- Serious cardiac arrhythmia
- Myocardial infarction within the past 6 months
- New York Heart Association class III-IV heart failure
- Severe uncontrolled ventricular arrhythmias
- Acute ischemia or active conduction system abnormalities by ECG
- No serious medical or psychiatric illness or social situation that would preclude participation in this study
- No pre-existing neuropathy ≥ grade 2
- No other serious neurologic toxicity that would significantly increase the risk of complications from bortezomib therapy
- Recovered from prior therapy (toxicity < grade 2)
- More than 14 days since prior investigational agents
- More than 2 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C) or radiotherapy
- Prior decitabine or azacitidine for myelodysplastic syndromes (MDS) or AML allowed
- More than 6 months since prior decitabine, azacitidine, or bortezomib
- No concurrent palliative radiotherapy
- No other concurrent investigational agents
- No other concurrent direct anti-leukemia therapy
Sites / Locations
- Ohio State University Medical Center
Arms of the Study
Arm 1
Experimental
Treatment (enzyme inhibitor therapy and chemotherapy)
Patients receive decitabine IV over 1 hour on days 1-5 or 1-10 and bortezomib IV on days 5 and 8 or days 5, 8, 12, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Once the maximum tolerated dose is determined, an additional 6 patients are treated at the recommended phase II dose.