Acute Myelogenous LeukemiaPhase 2/3NCT00398983
Randomized Study of Decitabine in Maintenance Therapy of Acute Myeloid Leukemia (AML)
A Phase 2/3 study testing Decitabine in people with Acute Myelogenous Leukemia, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical study is to find out whether continued therapy with decitabine after achieving a remission in acute myeloid leukemia (AML) patients can help prolong the remission and prevent relapse of the disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myelogenous Leukemia
- What is being tested?
- Decitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2006to May 2012
- Phase
- Phase 2/3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (greater than 18 years) with acute myelogenous leukemia (AML) by World Health Organization (WHO) criteria (greater than 20% blasts) and unfavorable risk cytogenetics (including intermediate and poor risk categories) in first CR or complete remission without full platelet recovery (CRp)
- Adult patients (greater than 18 years) in second or subsequent Complete Response (CR) (or CRp)
- Patients in first CR (or CRp) may have received any induction chemotherapy regimen; they may have received post-remission consolidation therapy (except for transplant) prior to inclusion in this protocol
- Patients in 2nd or subsequent CR (or CRp) may have received any appropriate salvage regimen before achieving CR and may have received further therapy before inclusion
- Performance status of 0, 1, or 2
- Adequate organ function with creatinine less than or equal to 2.0 mg/dL, bilirubin less than or equal to 3.5 mg/dL and aspartate aminotransferase (AST or SGOT) and alanine aminotransferase (ALT or SGPT) less than or equal to 3 times institutional upper limit of normal
Who cannot join
- Pregnant or lactating; women of child-bearing potential (WOCBP) must have negative pregnancy test. WOCBP defined as not post-menopausal for 12 months or no previous surgical sterilization
- Known to be HIV+
- Active and uncontrolled disease/infection as judged by the treating physician
- Unable or unwilling to sign the consent form
- No other investigational therapy within the past 14 days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Study of Decitabine Versus Observation or Continued Standard Chemotherapy as Maintenance Therapy for Adults With Unfavorable Risk AML in First Complete Remission (CR) or Adults With Relapsed AML in Second or Greater CR
The goal of this clinical study is to find out whether continued therapy with decitabine after achieving a remission in acute myeloid leukemia (AML) patients can help prolong the remission and prevent relapse of the disease.
Read the detailed description
Methylation is a change that occurs to DNA that has an effect on how genes are used in human cells. It is very common in leukemias for methylation to happen abnormally. Decitabine is a new drug that blocks DNA methylation. At low doses (such as those used in this study), decitabine blocks proteins important in abnormal DNA methylation, which may, in turn, allow leukemia cells to die and disappear.
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the toss of a coin) to one of 2 groups. Group 1 will receive decitabine about every 4-8 weeks to see whether this drug is useful in lengthening the duration of remission in patients like you. Group 2 will not receive the study drug.
If you are assigned to Group 1, the drug will be given over about 1 hour through a peripheral or central catheter every day for 5 days. A peripheral or central venous catheter is a sterile flexible tube that will be placed into a large vein while you are under local anesthesia. Your doctor will explain this procedure to you in more detail, and you will be required to sign a separate consent form for this procedure. You will receive the study drug for 5 days per study "cycle". Each cycle will be about 4-8 weeks. You must receive your study drug at M. D. Anderson Cancer Center.
You may remain on study for up to 12 Cycles. You will be taken off study if the disease gets worse, your doctor feels it is in your best interest, or you develop intolerable side effects.
During the study, blood (about 2 tablespoons) will be drawn for routine tests every week during the first month and then every 2-4 weeks after that. You will also have a bone marrow examination aspirate/biopsy every 3-6 months to make sure that your disease remains in remission.
If you are assigned to Group 2, you will continue under the care of your doctor. This will include study visits and having a bone marrow examination aspirate/biopsy every 3-6 months up to one year after randomization to make sure that the disease remains in remission.
Once you are off study, blood (about 2 tablespoons) will be drawn and you will have a bone marrow biopsy/aspirate.
This is an investigational study. Decitabine is FDA-approved and is commercially available. It is not FDA approved for this usage, and it has been authorized for use in research only. Up to 100 patients will take part in this study. All will be enrolled at M. D. Anderson.
- Conditions
- Acute Myelogenous Leukemia
- Being tested
- Decitabine
- Keywords
- Acute Myelogenous Leukemia, AML, Remission, Decitabine, Maintenance Therapy
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DecitabineDrug
Also called Dacogen
20 mg/m^2 IV over 1 hour daily for 5 days
| Study group | Role | What they receive |
|---|---|---|
| Decitabine 20 mg/m^2 | Experimental | 20 mg/m^2 intravenous (IV) daily for 5 days Receives: Drug: Decitabine |
| No Study Drug | No intervention | Continue current therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Relapse-Free Response at 1 Year
Relapse free response defined an absence of relapse at one year of follow up.
Measured: Baseline to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2006 (estimated)
- Study startAug 2006
- Primary completionMay 2012
- Study completionMay 2012
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 Acute Myelogenous LeukemiaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Eisai Inc.
- Responsible party
- Sponsor
- Investigators
- Farhad Ravandi-Kashani, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00398983
- Sponsor's protocol ID
- 2006-0358
- Status last verified
- Jan 2013
- First submitted
- 9 Nov 2006
- Last updated
- 4 Mar 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study of Decitabine Versus Observation or Continued Standard Chemotherapy as Maintenance Therapy for Adults With Unfavorable Risk AML in First Complete Remission (CR) or Adults With Relapsed AML in Second or Greater CR
- ClinicalTrials.gov ID
- NCT00398983
- Acronym / sponsor ID
- 2006-0358
- Conditions
- Acute Myelogenous Leukemia
- Keywords
- Acute Myelogenous Leukemia, AML, Remission, Decitabine, Maintenance Therapy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Eisai Inc.
- Study start
- Aug 2006
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 14 Nov 2006 (estimated)
- Results
- Posted 4 Mar 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical study is to find out whether continued therapy with decitabine after achieving a remission in acute myeloid leukemia (AML) patients can help prolong the remission and prevent relapse of the disease.
Detailed description
Methylation is a change that occurs to DNA that has an effect on how genes are used in human cells. It is very common in leukemias for methylation to happen abnormally. Decitabine is a new drug that blocks DNA methylation. At low doses (such as those used in this study), decitabine blocks proteins important in abnormal DNA methylation, which may, in turn, allow leukemia cells to die and disappear.
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the toss of a coin) to one of 2 groups. Group 1 will receive decitabine about every 4-8 weeks to see whether this drug is useful in lengthening the duration of remission in patients like you. Group 2 will not receive the study drug.
If you are assigned to Group 1, the drug will be given over about 1 hour through a peripheral or central catheter every day for 5 days. A peripheral or central venous catheter is a sterile flexible tube that will be placed into a large vein while you are under local anesthesia. Your doctor will explain this procedure to you in more detail, and you will be required to sign a separate consent form for this procedure. You will receive the study drug for 5 days per study "cycle". Each cycle will be about 4-8 weeks. You must receive your study drug at M. D. Anderson Cancer Center.
You may remain on study for up to 12 Cycles. You will be taken off study if the disease gets worse, your doctor feels it is in your best interest, or you develop intolerable side effects.
During the study, blood (about 2 tablespoons) will be drawn for routine tests every week during the first month and then every 2-4 weeks after that. You will also have a bone marrow examination aspirate/biopsy every 3-6 months to make sure that your disease remains in remission.
If you are assigned to Group 2, you will continue under the care of your doctor. This will include study visits and having a bone marrow examination aspirate/biopsy every 3-6 months up to one year after randomization to make sure that the disease remains in remission.
Once you are off study, blood (about 2 tablespoons) will be drawn and you will have a bone marrow biopsy/aspirate.
This is an investigational study. Decitabine is FDA-approved and is commercially available. It is not FDA approved for this usage, and it has been authorized for use in research only. Up to 100 patients will take part in this study. All will be enrolled at M. D. Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Decitabine 20 mg/m^2 | Experimental | Drug: Decitabine20 mg/m^2 intravenous (IV) daily for 5 days |
| No Study Drug | No intervention | –Continue current therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult patients (greater than 18 years) with acute myelogenous leukemia (AML) by World Health Organization (WHO) criteria (greater than 20% blasts) and unfavorable risk cytogenetics (including intermediate and poor risk categories) in first CR or complete remission without full platelet recovery (CRp)
- Adult patients (greater than 18 years) in second or subsequent Complete Response (CR) (or CRp)
- Patients in first CR (or CRp) may have received any induction chemotherapy regimen; they may have received post-remission consolidation therapy (except for transplant) prior to inclusion in this protocol
- Patients in 2nd or subsequent CR (or CRp) may have received any appropriate salvage regimen before achieving CR and may have received further therapy before inclusion
- Performance status of 0, 1, or 2
Key exclusion criteria (5 listed)
- Pregnant or lactating; women of child-bearing potential (WOCBP) must have negative pregnancy test. WOCBP defined as not post-menopausal for 12 months or no previous surgical sterilization
- Known to be HIV+
- Active and uncontrolled disease/infection as judged by the treating physician
- Unable or unwilling to sign the consent form
- No other investigational therapy within the past 14 days
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 |
|---|---|---|
| DecitabineAlso: Dacogen20 mg/m^2 IV over 1 hour daily for 5 days | Drug | Decitabine 20 mg/m^2 |
Primary outcome
Number of Participants With Relapse-Free Response at 1 Year
Time frame: Baseline to 1 year
Relapse free response defined an absence of relapse at one year of follow up.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- M.D. Anderson's websiteLink provided by the sponsor.
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RecruitingPhase 2
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ATRN-119 in Combination With Decitabine in Patients With TP53-Mutated AML or Higher-Risk MDS
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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.
Farhad Ravandi-Kashani, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Decitabine in people with Acute Myelogenous Leukemia, run by M.D. Anderson Cancer 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 6 inclusion and 5 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 4 Mar 2013. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 4 Mar 2013). 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?
Number of Participants With Relapse-Free Response at 1 Year (time frame: Baseline to 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 4 Mar 2013.