Status:
UNKNOWN
Trial With Azacitidine in Newly Diagnosed Acute Myelogenous Leukemia (AML) Veterans Administration (VA) Elderly Patients Not Eligible for Standard Induction Therapy
Lead Sponsor:
Kansas City Veteran Affairs Medical Center
Conditions:
Acute Myeloid Leukemia
Elderly
Eligibility:
All Genders
60+ years
Phase:
PHASE2
Brief Summary
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...
Detailed Description
Prior to starting treatment individuals being considered for this study will be evaluated to determine if they are eligible to participate in the study. There are certain prestudy test that are requir...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2012
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00728520
Start Date
July 1 2008
End Date
June 1 2012
Last Update
August 6 2008
Active Locations (1)
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1
Kansas City Veterans Affairs Medical Center
Kansas City, Missouri, United States, 64218