- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00728520
Trial With Azacitidine in Newly Diagnosed Acute Myelogenous Leukemia (AML) Veterans Administration (VA) Elderly Patients Not Eligible for Standard Induction Therapy
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 Overview
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
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Sarah Spencer, RN, BSN
- Phone Number: 57665 816-861-4700
- Email: sarah.spencer@va.gov
Study Contact Backup
- Name: Suman Kambhampati, MD
- Phone Number: 816-861-4700
- Email: suman.kambhampati@va.gov
Study Locations
-
-
Missouri
-
Kansas City, Missouri, United States, 64218
- Recruiting
- Kansas City Veterans Affairs Medical Center
-
Principal Investigator:
- Suman Kambhampati, MD
-
Contact:
- Sarah E Spencer, RN, BSN
- Phone Number: 57665 816-861-4700
- Email: sarah.spencer@va.gov
-
Contact:
- Suman Kambhampati, MD
- Phone Number: 57075 816-861-4700
- Email: suman.kambhampati@va.gov
-
Sub-Investigator:
- Peter J. Van Veldhuizen, MD
-
Sub-Investigator:
- Chao H. Huang, MD
-
Sub-Investigator:
- Chester Stone, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
overall response rates, duration of response, toxicities
Time Frame: Starting 4 weeks after treatment, during the entire study duration, and upon study completion
|
Starting 4 weeks after treatment, during the entire study duration, and upon study completion
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
During the entire duration of the study and after study completion
|
Collaborators and Investigators
Investigators
- Principal Investigator: Amit Verma, MD, Albert Einstein College Of Medicine
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SK0010
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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