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

Sponsor

Kansas City Veteran Affairs Medical Center (U.S. Fed)

Overall Status

Unknown status

CT.gov ID

NCT00728520

Collaborator

(none)

Enrollment

Location

Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

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

Study Type:

Interventional

Anticipated 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 :

Jul 1, 2008

Anticipated Primary Completion Date :

Jun 1, 2010

Anticipated Study Completion Date :

Jun 1, 2012

Outcome Measures

Primary Outcome Measures

overall response rates, duration of response, toxicities [Starting 4 weeks after treatment, during the entire study duration, and upon study completion]

Secondary Outcome Measures

leukemia free survival, overall survival, quality of life, assess biomarkers and predictive markers for Azacitidine responsiveness in elderly AML patients [During the entire duration of the study and after study completion]

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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