LeukemiaPhase 2NCT00387647
Maintenance Azacitidine in Elderly Patients With Acute Myeloid Leukemia (AML) in CR After Induction Chemotherapy
A Phase 2 study testing Azacitidine in people with Leukemia, run by H. Lee Moffitt Cancer Center and Research Institute at 2 sites in United States.
Trial summary
The purpose of this study is to find out if patients older than 60, with acute myeloid leukemia, who are in complete remission following initial chemotherapy, will live longer and have a lower rate of leukemia relapse when treated with azacitidine. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Leukemia
- What is being tested?
- Azacitidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2006to Aug 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Histologic or cytologic confirmation of AML with greater than 20% blasts in bone marrow. All AML subtypes of the World Health Organization (WHO) classification will be included with the exception of promyelocytic leukemia and cytogenetics showing the (15;17) translocation or AML secondary to chemotherapy.
- Achieved first morphologic complete remission (CR) or first morphologic complete remission with incomplete platelet recovery (CRp) after completion of induction chemotherapy using a standard induction regimen. Up to 2 induction cycles will be allowed. Confirmation of CR is defined as < 5% blasts in the bone marrow specimen, with a count of at least 100-200 nucleated cells and absence of Auer rods, along with peripheral blood neutrophil count >1.0 x 10^9/L and platelet count >100 x 10^9/L. Confirmation of CRp is defined as <5% blasts in the bone marrow specimen, with a count of at least 100-200 nucleated cells and absence of Auer rods, with incomplete platelet recovery (ANC ≥ 1000/µL and platelets 50-99,000/µL, along with transfusion-independence of red blood cells).
- Received up to 2 cycles of any consolidation chemotherapy
- Have an Eastern Cooperative Oncology Group (ECOG) performance status ≤2
- Normal organ function at the time of screening: Total bilirubin ≤1.5 x upper limit of normal (ULN); aspartic transaminase (AST) and alanine transaminase (ALT) ≤2.5 x ULN; Serum creatinine ≤1.5 x ULN or creatinine clearance >60 mL/min for patients with creatinine levels above ULN
- Men must agree to avoid fathering a child throughout the study.
- Be capable of giving informed consent and have signed the informed consent form (ICF)
Who cannot join
- Greater than 12 weeks since initiation of most recent cycle of consolidation chemotherapy
- Women of childbearing potential
- Prior relapse after complete remission for AML
- AML secondary to previous exposure to cytotoxic chemotherapy known to induce leukemia
- Active malignancy other than AML
- Any diagnosis of metastatic disease
Show all 14Show fewer
- Have hepatic tumors
- Radiation therapy, chemotherapy, or cytotoxic therapy, given to treat conditions other than AML <4 weeks prior to Day 1 or have not recovered from adverse events due to agents administered >4 weeks earlier
- Known leukemic involvement of the central nervous system
- Known or suspected hypersensitivity to azacitidine or mannitol
- Prior or active disease that, in the opinion of the Investigator, may interfere with the procedures or evaluations to be conducted in the study (uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements)
- Active viral infection with known human immunodeficiency virus (HIV) or viral hepatitis type B or C
- Treatment with other investigational drugs within the 30 days prior to Day 1, or ongoing adverse events from previous treatment with investigational drugs, regardless of the time period
- Any prior treatment with azacitidine or decitabine
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Duke University Medical Center
Durham, North Carolina, 27710
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
About this study
Official title: A Multicenter, Phase 2 Study of Maintenance Azacitidine in Elderly Patients With Acute Myeloid Leukemia in Complete Remission After Induction Chemotherapy
The purpose of this study is to find out if patients older than 60, with acute myeloid leukemia, who are in complete remission following initial chemotherapy, will live longer and have a lower rate of leukemia relapse when treated with azacitidine.
Read the detailed description
Patient activity will encompass approximately 48 months: an approximate 24 month enrollment period, followed by 6 to 12 months of patient treatment. Patients will be followed for 1 year following completion of study drug treatment. During follow-up, bone marrow biopsies to confirm disease status should be obtained if peripheral blood blasts are present or if there is development of unexpected blood abnormalities to warrant suspicion of relapse, or at a minimum of every 6 months.
- Conditions
- Leukemia
- Being tested
- Azacitidine
- Keywords
- myeloid, acute, monocytic
- Medical subject headings
- 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 given subcutaneously as outlined in treatment arm.
| Study group | Role | What they receive |
|---|---|---|
| Azacitidine Treatment | Experimental | Azacitidine 50 mg/m^2 subcutaneously daily for 5 days (Monday through Friday) on days 1 through 5, every 28 days for 6-12 cycles. Receives: Drug: Azacitidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Disease Free Survival at One Year
The primary efficacy variable is disease free survival measured at one year, which is the percentage of patients who remain alive and disease free one year after the confirmation of remission by bone marrow biopsy. Relapse is defined by a bone marrow specimen with >5% blasts or the presence of Auer rods.
Measured: 1 year
Secondary outcomes (2)
Overall Survival (OS)
The secondary efficacy variable is overall survival measured as time to death, which is the time from remission until death from any cause.
Measured: 48 months
Number of Participants With Adverse Events
Safety and tolerability of treatment as measured by NCI Common Terminology Criteria for Adverse Events (CTCAE) v3.0
Measured: 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2006 (estimated)
- Study startAug 2006
- Primary completionOct 2013
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Celgene Corporation
- Responsible party
- Sponsor
- Investigators
- Jeffrey E. Lancet, M.D., Principal investigator, H. Lee Moffitt Cancer Center and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00387647
- Sponsor's protocol ID
- MCC-14496
- Status last verified
- Aug 2014
- First submitted
- 12 Oct 2006
- Last updated
- 22 Aug 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Phase 2 Study of Maintenance Azacitidine in Elderly Patients With Acute Myeloid Leukemia in Complete Remission After Induction Chemotherapy
- ClinicalTrials.gov ID
- NCT00387647
- Acronym / sponsor ID
- MCC-14496
- Conditions
- Leukemia
- Keywords
- myeloid, acute, monocytic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- Celgene Corporation
- Study start
- Aug 2006
- Primary completion
- Oct 2013 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 13 Oct 2006 (estimated)
- Results
- Posted 30 Jun 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to find out if patients older than 60, with acute myeloid leukemia, who are in complete remission following initial chemotherapy, will live longer and have a lower rate of leukemia relapse when treated with azacitidine.
Detailed description
Patient activity will encompass approximately 48 months: an approximate 24 month enrollment period, followed by 6 to 12 months of patient treatment. Patients will be followed for 1 year following completion of study drug treatment. During follow-up, bone marrow biopsies to confirm disease status should be obtained if peripheral blood blasts are present or if there is development of unexpected blood abnormalities to warrant suspicion of relapse, or at a minimum of every 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Azacitidine Treatment | Experimental | Drug: AzacitidineAzacitidine 50 mg/m^2 subcutaneously daily for 5 days (Monday through Friday) on days 1 through 5, every 28 days for 6-12 cycles. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologic or cytologic confirmation of AML with greater than 20% blasts in bone marrow. All AML subtypes of the World Health Organization (WHO) classification will be included with the exception of promyelocytic leukemia and cytogenetics showing the (15;17) translocation or AML secondary to chemotherapy.
- Achieved first morphologic complete remission (CR) or first morphologic complete remission with incomplete platelet recovery (CRp) after completion of induction chemotherapy using a standard induction regimen. Up to 2 induction cycles will be allowed. Confirmation of CR is defined as < 5% blasts in the bone marrow specimen, with a count of at least 100-200 nucleated cells and absence of Auer rods, along with peripheral blood neutrophil count >1.0 x 10^9/L and platelet count >100 x 10^9/L. Confirmation of CRp is defined as <5% blasts in the bone marrow specimen, with a count of at least 100-200 nucleated cells and absence of Auer rods, with incomplete platelet recovery (ANC ≥ 1000/µL and platelets 50-99,000/µL, along with transfusion-independence of red blood cells).
- Received up to 2 cycles of any consolidation chemotherapy
- Have an Eastern Cooperative Oncology Group (ECOG) performance status ≤2
- Normal organ function at the time of screening: Total bilirubin ≤1.5 x upper limit of normal (ULN); aspartic transaminase (AST) and alanine transaminase (ALT) ≤2.5 x ULN; Serum creatinine ≤1.5 x ULN or creatinine clearance >60 mL/min for patients with creatinine levels above ULN
Key exclusion criteria (14 listed)
- Greater than 12 weeks since initiation of most recent cycle of consolidation chemotherapy
- Women of childbearing potential
- Prior relapse after complete remission for AML
- AML secondary to previous exposure to cytotoxic chemotherapy known to induce leukemia
- Active malignancy other than AML
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: Vidaza™Azacitidine given subcutaneously as outlined in treatment arm. | Drug | Azacitidine Treatment |
Primary outcome
Rate of Disease Free Survival at One Year
Time frame: 1 year
The primary efficacy variable is disease free survival measured at one year, which is the percentage of patients who remain alive and disease free one year after the confirmation of remission by bone marrow biopsy. Relapse is defined by a bone marrow specimen with >5% blasts or the presence of Auer rods.
2 secondary outcomes
Overall Survival (OS)
Time frame: 48 months
Number of Participants With Adverse Events
Time frame: 48 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Jeffrey E. Lancet, M.D. principal investigator
H. Lee Moffitt Cancer Center and Research Institute
2 sites 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 Leukemia, run by H. Lee Moffitt Cancer Center and Research Institute at 2 sites 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 7 inclusion and 14 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: finished, as of the sponsor's last update on 22 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 30 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Disease Free Survival at One Year (time frame: 1 year). 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 22 Aug 2014; AzTrials last refreshed its copy on 7 Nov 2026.