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

Sponsored by:	Kansas City Veteran Affairs Medical Center
Information provided by:	Kansas City Veteran Affairs Medical Center
ClinicalTrials.gov Identifier:	NCT00728520

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.

Condition	Intervention	Phase
Acute Myeloid Leukemia Elderly	Drug: Azacitidine	Phase II

MedlinePlus related topics: Leukemia, Adult Acute Leukemia, Adult Chronic

Drug Information available for: Azacitidine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
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

Further study details as provided by Kansas City Veteran Affairs Medical Center:

Primary Outcome Measures:

overall response rates, duration of response, toxicities [ Time Frame: Starting 4 weeks after treatment, during the entire study duration, and upon study completion ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	40
Study Start Date:	July 2008
Estimated Study Completion Date:	June 2012
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Intervention Details:

Azacitidine 75 mg/m2 daily IV or subcutaneously (SQ) for 5 days, every 4 weeks for a minimum of 4 cycles.

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.

Eligibility

Ages Eligible for Study:	60 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00728520

Contacts

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

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

Principal Investigator:

Amit Verma, MD

Albert Einstein College of Medicine of Yeshiva University

More Information

Responsible Party:	Kansas City Veterans Affairs Medical Center ( Suman Kambhampati, MD )
Study ID Numbers:	SK0010
Study First Received:	July 31, 2008
Last Updated:	August 5, 2008
ClinicalTrials.gov Identifier:	NCT00728520
Health Authority:	United States: Federal Government; United States: Food and Drug Administration

Keywords provided by Kansas City Veteran Affairs Medical Center:

Leukemia
Azacitidine
Untreated
Elderly

Study placed in the following topic categories:

Leukemia
Azacitidine
Acute myelogenous leukemia

Leukemia, Myeloid
Leukemia, Myeloid, Acute
Acute myelocytic leukemia

Additional relevant MeSH terms:

Antimetabolites
Neoplasms
Antimetabolites, Antineoplastic
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 13, 2009