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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00728520
Recruitment Status : Unknown
Verified August 2008 by Kansas City Veteran Affairs Medical Center.
Recruitment status was:  Recruiting
First Posted : August 6, 2008
Last Update Posted : August 6, 2008
Sponsor:
Information provided by:
Kansas City Veteran Affairs Medical Center

Study Description
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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. 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.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Elderly Drug: Azacitidine Phase 2

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 required: physical exam, blood tests, ECG, chest x-ray, bone marrow aspirate and biopsy to confirm the diagnosis of AML.

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial With Azacitidine Single Agent in Newly Diagnosed Acute Myelogenous Leukemia (AML) Veterans Administration (VA) Elderly Patients Who Are Ineligible for Standard Induction Therapy: A Department of Veterans Affairs Multi-Site Study
Study Start Date : July 2008
Estimated Primary Completion Date : June 2010
Estimated Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Azacitidine

Arms and Interventions
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Intervention Details:
  • Drug: Azacitidine
    Azacitidine 75 mg/m2 daily IV or subcutaneously (SQ) for 5 days, every 4 weeks for a minimum of 4 cycles.
    Other Name: Vidaza

Outcome Measures
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Primary Outcome Measures :
  1. overall response rates, duration of response, toxicities [ Time Frame: Starting 4 weeks after treatment, during the entire study duration, and upon study completion ]

Secondary Outcome Measures :
  1. leukemia free survival, overall survival, quality of life, assess biomarkers and predictive markers for Azacitidine responsiveness in elderly AML patients [ Time Frame: During the entire duration of the study and after study completion ]

Eligibility Criteria
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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00728520


Contacts
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Contact: Sarah Spencer, RN, BSN 816-861-4700 ext 57665 sarah.spencer@va.gov
Contact: Suman Kambhampati, MD 816-861-4700 suman.kambhampati@va.gov

Locations
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United States, Missouri
Kansas City Veterans Affairs Medical Center Recruiting
Kansas City, Missouri, United States, 64218
Contact: Sarah E Spencer, RN, BSN    816-861-4700 ext 57665    sarah.spencer@va.gov   
Contact: Suman Kambhampati, MD    816-861-4700 ext 57075    suman.kambhampati@va.gov   
Principal Investigator: Suman Kambhampati, MD         
Sub-Investigator: Peter J. Van Veldhuizen, MD         
Sub-Investigator: Chao H. Huang, MD         
Sub-Investigator: Chester Stone, MD         
Sponsors and Collaborators
Kansas City Veteran Affairs Medical Center
Investigators
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Principal Investigator: Amit Verma, MD Albert Einstein College of Medicine
More Information
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Responsible Party: Suman Kambhampati, MD, Kansas City Veterans Affairs Medical Center
ClinicalTrials.gov Identifier: NCT00728520    
Other Study ID Numbers: SK0010
First Posted: August 6, 2008    Key Record Dates
Last Update Posted: August 6, 2008
Last Verified: August 2008
Keywords provided by Kansas City Veteran Affairs Medical Center:
Leukemia
Azacitidine
Untreated
Elderly
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Neoplasms by Histologic Type
Neoplasms
Azacitidine
 Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors