Trial With Azacitidine in Newly Diagnosed Acute Myelogenous Leukemia (AML) Veterans Administration (VA) Elderly Patients Not Eligible for Standard Induction Therapy
NCT ID: NCT00728520
Last Updated: 2008-08-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
40 participants
INTERVENTIONAL
2008-07-31
2012-06-30
Brief Summary
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Detailed Description
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Treatment regimen consists of Azacitidine IV/SQ on days 1-5 every 28 days. If the Azacitidine is given IV it will be given over 15-40 minutes. The treatment will be given for a minimum of 4 treatment cycles. Blood samples will be taken every week to monitor for side effects of the Azacitidine. A bone marrow aspirate will be done every 3-4 months to determine the response to the study drug or until the disease progresses. There is also a quality of life questionnaire that will be completed at the beginning of the study and every 4 weeks while on the study.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Azacitidine
Azacitidine 75 mg/m2 daily IV or subcutaneously (SQ) for 5 days, every 4 weeks for a minimum of 4 cycles.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
60 Years
ALL
No
Sponsors
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Kansas City Veteran Affairs Medical Center
FED
Responsible Party
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Kansas City Veterans Affairs Medical Center
Principal Investigators
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Amit Verma, MD
Role: PRINCIPAL_INVESTIGATOR
Albert Einstein College of Medicine
Locations
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Kansas City Veterans Affairs Medical Center
Kansas City, Missouri, United States
Countries
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Central Contacts
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Facility Contacts
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Sarah E Spencer, RN, BSN
Role: primary
Suman Kambhampati, MD
Role: backup
Other Identifiers
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SK0010
Identifier Type: -
Identifier Source: org_study_id