Acute Myeloid LeukemiaPhase 2NCT00728520
Trial With Azacitidine in Newly Diagnosed Acute Myelogenous Leukemia (AML) Veterans Administration (VA) Elderly Patients Not Eligible for Standard Induction Therapy
A Phase 2 study testing Azacitidine in people with Acute Myeloid Leukemia and Elderly, run by Kansas City Veteran Affairs Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Acute Myeloid Leukemia, Elderly
- What is being tested?
- Azacitidine
- Type of treatment
- Injection or infusion
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Jun 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Kansas City Veterans Affairs Medical Center
Kansas City, Missouri, 64218
Sarah E Spencer, RN, BSN, 816-861-4700 ext. 57665, sarah.spencer@va.gov
Suman Kambhampati, MD, 816-861-4700 ext. 57075, suman.kambhampati@va.gov
About this 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
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.
Read the 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.
- Conditions
- Acute Myeloid Leukemia, Elderly
- Being tested
- Azacitidine
- Keywords
- Leukemia, Azacitidine, Untreated, Elderly
- Medical subject headings
- Leukemia, Myeloid, Acute, Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AzacitidineDrug
Also called Vidaza
Azacitidine 75 mg/m2 daily IV or subcutaneously (SQ) for 5 days, every 4 weeks for a minimum of 4 cycles.
What is being measured
The primary outcome is the main question the study is designed to answer.
overall response rates, duration of response, toxicities
Measured: Starting 4 weeks after treatment, during the entire study duration, and upon study completion
Secondary outcomes (1)
leukemia free survival, overall survival, quality of life, assess biomarkers and predictive markers for Azacitidine responsiveness in elderly AML patients
Measured: During the entire duration of the study and after study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2008 (estimated)
- Study startJul 2008
- Primary completionJun 2010 (estimated)
- Study completionJun 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kansas City Veteran Affairs Medical Center
- Sponsor type
- US federal agency
- Investigators
- Amit Verma, MD, Principal investigator, Albert Einstein College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00728520
- Sponsor's protocol ID
- SK0010
- Status last verified
- Aug 2008
- First submitted
- 31 Jul 2008
- Last updated
- 6 Aug 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00728520
- Acronym / sponsor ID
- SK0010
- Conditions
- Acute Myeloid Leukemia, Elderly
- Keywords
- Leukemia, Azacitidine, Untreated, Elderly
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Kansas City Veteran Affairs Medical CenterUS federal agency
- Study start
- Jul 2008
- Primary completion
- Jun 2010 (estimated)
- Study completion
- Jun 2012 (estimated)
- First posted
- 6 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AzacitidineAlso: VidazaAzacitidine 75 mg/m2 daily IV or subcutaneously (SQ) for 5 days, every 4 weeks for a minimum of 4 cycles. | Drug | – |
Primary outcome
overall response rates, duration of response, toxicities
Time frame: Starting 4 weeks after treatment, during the entire study duration, and upon study completion
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amit Verma, MD principal investigator
Albert Einstein College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Azacitidine in people with Acute Myeloid Leukemia and Elderly, run by Kansas City Veteran Affairs Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sarah Spencer, RN, BSN (816-861-4700 ext. 57665, sarah.spencer@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall response rates, duration of response, toxicities (time frame: Starting 4 weeks after treatment, during the entire study duration, and upon study completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2008.