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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified August 2008 by Kansas City Veteran Affairs Medical Center.
Recruitment status was Recruiting

Sponsor:

Information provided by:

Kansas City Veteran Affairs Medical Center

ClinicalTrials.gov Identifier:

NCT00728520

First received: July 31, 2008

Last updated: August 5, 2008

Last verified: August 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

July 31, 2008

Last Updated Date

August 5, 2008

Start Date ^ICMJE

July 2008

Estimated Primary Completion Date

June 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00728520 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

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

Phase 2

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

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

Gender

Both

Ages

60 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

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

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00728520

Other Study ID Numbers ^ICMJE

SK0010

Has Data Monitoring Committee

Yes

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 of Yeshiva University

Information Provided By

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

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