Trial With Azacitidine in Newly Diagnosed Acute Myelogenous Leukemia (AML) Veterans Administration (VA) Elderly Patients Not Eligible for Standard Induction Therapy

Status unconfirmed · Phase 2

Conditions studied: Acute Myeloid Leukemia, Elderly

In brief

The drug that will be used in this study is called Azacitidine. Azacitidine belongs to a group of drugs which may restore normal control in cancer cells by affecting the genes and proteins in the body. Azacitidine is approved by the FDA for the treatment of Myelodysplastic Syndrome (MDS), a pre-leukemic bone marrow disease. The purpose of this study is to find out what effect the drug Azacitidine has on Acute Myeloid Leukemia (AML) in elderly patients.

Key facts

Study ID

NCT00728520

Run by

Kansas City Veteran Affairs Medical Center

People needed

40

Starts

2008-07-01

Expected to finish

2012-06-01

Last updated by the study team

2008-08-06

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of AML
• Elderly patients with denovo AML or secondary AML evolving from MDS in patient >/= 60 who decline chemotherapy or those who are not currently candidates for induction chemotherapy
• Stable WBC <10 x 109 and not requiring hydroxyurea, chemotherapy or leukapheresis for >4 weeks
• No corticosteroids, hydroxyurea, low-dose cytarabine, interferon, ir retinoids within 1 month
• No prior decitabine
• No valproic acid or other histone deacetylase inhibitor for at least 2 weeks
• No G-CSF, or GM-CSF or Erythropoetin within 1 month of study entry
• No investigational agents within 28 days
• ECOG performance status </= 2 or KPS >/= 60%
• Life expectancy > 2 months
• Normal organ function = Total bilirubin </= 1.5 x ULN, AST/ALT </= 2.5 x ULN
• Creatinine within normal limits or creatinine clearance >/= 60ml/min
• Signed informed consent

You may not qualify if…

• Patients with t(15;17) or M3-AML
• Patients who have had chemotherapy or radiotherapy within 4 weeks prior to study entry, or who have not recovered from adverse effects of agents administered earlier
• Patients with CNS involvement of AML
• History of allergic reactions attributed to Azacitidine or compounds of similar chemical used in this study
• Pregnancy
• Other serious medical or psychiatric illness which would limit survival to < 3 months or prevent the granting of informed consent or lead to situations that would limit compliance with study requirements
• Known positive serology for HIV, HIV positive patients with anti-retroviral therapy are ineligible
• Active systemic bacterial, fungal or viral infection
• Patients with severe complications of the leukemia including but not limited to active infection, uncontrolled infection, pneumonia, hypoxia, and shock
• Patients with advanced hepatic tumors
• Patients with poor history of medical compliance
• Patients with known platelet refractoriness

Where it is running

• Kansas City Veterans Affairs Medical Center — Kansas City, Missouri, United States (enrolling)

Full record on ClinicalTrials.gov

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