Clinical Trials /

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

NCT00728520

Description:

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.

Related Conditions:
  • Acute Myeloid Leukemia
Recruiting Status:

Unknown status

Phase:

Phase 2

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: SK0010
  • NCT ID: NCT00728520

Conditions

  • Acute Myeloid Leukemia
  • Elderly

Interventions

DrugSynonymsArms
AzacitidineVidaza

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions

Eligibility 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:60 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:overall response rates, duration of response, toxicities
Time Frame:Starting 4 weeks after treatment, during the entire study duration, and upon study completion
Safety Issue:
Description:

Secondary Outcome Measures

Measure: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
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Unknown status
Lead Sponsor:Kansas City Veteran Affairs Medical Center

Trial Keywords

  • Leukemia
  • Azacitidine
  • Untreated
  • Elderly

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