Trial With Azacitidine in Newly Diagnosed Acute Myelogenous Leukemia (AML) Veterans Administration (VA) Elderly Patients Not Eligible for Standard Induction Therapy
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ClinicalTrials.gov Identifier: NCT00728520 |
Recruitment Status
: Unknown
Verified August 2008 by Kansas City Veteran Affairs Medical Center.
Recruitment status was: Recruiting
First Posted
: August 6, 2008
Last Update Posted
: August 6, 2008
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Acute Myeloid Leukemia Elderly | Drug: Azacitidine | Phase 2 |
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 : | Interventional (Clinical Trial) |
Estimated 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 : | July 2008 |
Estimated Primary Completion Date : | June 2010 |
Estimated Study Completion Date : | June 2012 |

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Drug: Azacitidine
- overall response rates, duration of response, toxicities [ Time Frame: Starting 4 weeks after treatment, during the entire study duration, and upon study completion ]
- 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 ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 60 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00728520
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 |
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 |
Principal Investigator: | Amit Verma, MD | Albert Einstein College of Medicine, Inc. |
Responsible Party: | Suman Kambhampati, MD, Kansas City Veterans Affairs Medical Center |
ClinicalTrials.gov Identifier: | NCT00728520 History of Changes |
Other Study ID Numbers: |
SK0010 |
First Posted: | August 6, 2008 Key Record Dates |
Last Update Posted: | August 6, 2008 |
Last Verified: | August 2008 |
Keywords provided by Kansas City Veteran Affairs Medical Center:
Leukemia Azacitidine Untreated Elderly |
Additional relevant MeSH terms:
Leukemia Leukemia, Myeloid, Acute Leukemia, Myeloid Neoplasms by Histologic Type Neoplasms Azacitidine |
Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Enzyme Inhibitors |