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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. 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
Information provided by:
Kansas City Veteran Affairs Medical Center

Tracking Information
First Submitted Date  ICMJE July 31, 2008
First Posted Date  ICMJE August 6, 2008
Last Update Posted Date August 6, 2008
Study Start Date  ICMJE July 2008
Estimated Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 5, 2008)
overall response rates, duration of response, toxicities [ Time Frame: Starting 4 weeks after treatment, during the entire study duration, and upon study completion ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 5, 2008)
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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Trial With Azacitidine in Newly Diagnosed Acute Myelogenous Leukemia (AML) Veterans Administration (VA) Elderly Patients Not Eligible for Standard Induction Therapy
Official Title  ICMJE 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
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Acute Myeloid Leukemia
  • Elderly
Intervention  ICMJE 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
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 5, 2008)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2012
Estimated Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00728520
Other Study ID Numbers  ICMJE SK0010
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Suman Kambhampati, MD, Kansas City Veterans Affairs Medical Center
Study Sponsor  ICMJE Kansas City Veteran Affairs Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Amit Verma, MD Albert Einstein College of Medicine
PRS Account Kansas City Veteran Affairs Medical Center
Verification Date August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP