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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


Phase 2
60 Years
N/A
Open (Enrolling)
Both
Acute Myeloid Leukemia, Elderly

Thank you

Trial Information

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


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.


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 /= 60%

- Life expectancy > 2 months

- Normal organ function = Total bilirubin
- 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

overall response rates, duration of response, toxicities

Outcome Time Frame:

Starting 4 weeks after treatment, during the entire study duration, and upon study completion

Safety Issue:

Yes

Principal Investigator

Amit Verma, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Albert Einstein College of Medicine of Yeshiva University

Authority:

United States: Federal Government

Study ID:

SK0010

NCT ID:

NCT00728520

Start Date:

July 2008

Completion Date:

June 2012

Related Keywords:

  • Acute Myeloid Leukemia
  • Elderly
  • Leukemia
  • Azacitidine
  • Untreated
  • Elderly
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

Name

Location
Kansas City Veterans Affairs Medical Center Kansas City, Missouri  64128