Myelodysplastic SyndromePhase 2NCT00260065
A Study of Decitabine Given to Adults With Advanced-Stage Myelodysplastic Syndromes
A Phase 2 study testing Decitabine in people with Myelodysplastic Syndrome, run by Eisai Inc. at 21 sites in 2 countries.
Trial summary
The purpose of this study is to determine the overall response rate in patients with myelodysplastic syndromes (MDS) given a daily dosing schedule of decitabine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelodysplastic Syndrome
- 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
- 99 participants
- Where
- 21 sitesin 2 countries
- Study dates
- May 2005to Dec 2008
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must sign an Institutional Review Board (IRB) -approved informed consent form.
- Must be 18 years of age or older.
- Must have a diagnosis for MDS fitting any of the recognized French-American-British (FAB) classifications and International Prognostic Scoring System (IPSS) greater than or equal to 0.5 as determined by Complete Blood Count (CBC), bone marrow assessment, and cytogenetics within 28 days of receiving study drug. If FAB classification is Refractory anemia (RA) or Refractory anemia with ringed sideroblasts (RARS), then must be red cell transfusion dependent, defined as needing red cells more frequently than once every 4 weeks.
- If receiving erythropoietin(Procrit), must have been on a stable dose for at least 8 weeks before first dose of study drug.
- If receiving darbepoetin(Aranesp), must have been on a stable dose for at least 12 weeks before first dose of study drug.
Who cannot join
- Must not have a diagnosis of Acute Myeloid Leukemia (AML) or other progressive malignant disease.
- Must not have received any investigational agent within the 30 days preceding the first dose of study drug.
- Must not have uncontrolled cardiac disease or uncontrolled congestive heart failure.
- Must not have an active viral or bacterial infection.
Trial locations and contacts
21 sites in 2 countries.
21 sites in 2 countries
United States20 sites
Study site
Birmingham, Alabama, 35235
Study site
Boca Raton, Florida, 33486
Study site
Buffalo, New York, 14263
Study site
Canton, Ohio, 44718
Study site
Charleston, South Carolina, 29406
Study site
Chicago, Illinois, 60637-1470
Study site
Fort Myers, Florida
Study site
Griffin, Georgia, 30224
Study site
Hackensack, New Jersey, 07601
Study site
Houston, Texas, 77030
Study site
Jacksonville, Florida
Study site
La Crosse, Wisconsin, 54601
Study site
Maywood, Illinois, 60153
Study site
Memphis, Tennessee, 38138
Study site
Midland, Texas, 79701
Study site
Milwaukee, Wisconsin, 53215
Study site
New Port Richey, Florida, 34652
Study site
Phoenix, Arizona
Study site
Rochester, Minnesota, 55905
Study site
Seattle, Washington, 98104
About this study
Official title: A Phase 2 Study of Decitabine Administered Daily for 5 Days Every 4 Weeks to Adults With Advanced-Stage Myelodysplastic Syndromes
The purpose of this study is to determine the overall response rate in patients with myelodysplastic syndromes (MDS) given a daily dosing schedule of decitabine.
- Conditions
- Myelodysplastic Syndrome
- Being tested
- Decitabine
- Keywords
- Myelodysplastic Syndrome, Decitabine, Dacogen, MGI Pharma
- Medical subject headings
- Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DecitabineDrug
Also called Dacogen
20mg/m^2, IV on days 1-5 of each 28 day cycle; until progression, death or unacceptable toxicity develops.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Decitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Achieved Overall Response
Overall Response = complete remission (disappearance of all target lesions) + partial remission (at least 30% decrease in the sum of the longest diameters of target lesions)
Measured: 1 year
Secondary outcomes (1)
Best Response and Overall Improvement
Overall Improvement = complete remission + marrow complete remission + partial remission + hematologic improvement (CR+mCR+PR+HI)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2005 (estimated)
- Study startMay 2005
- Primary completionJun 2008
- Study completionDec 2008
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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Myelodysplastic SyndromeStudies of the same condition, open and under way.
- More trials run by Eisai Inc.The 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eisai US Medical Services, Study director, Eisai Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00260065
- Sponsor's protocol ID
- DACO-020
- Status last verified
- Jun 2010
- First submitted
- 28 Nov 2005
- Last updated
- 20 May 2013
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Jabbour E, Kantarjian H, O'Brien S, Kadia T, Malik A, Welch MA, Teng A, Cortes J, Ravandi F, Garcia-Manero G. Retrospective analysis of prognostic factors associated with response and overall survival by baseline marrow blast percentage in patients with myelodysplastic syndromes treated with decitabine. Clin Lymphoma Myeloma Leuk. 2013 Oct;13(5):592-6. doi: 10.1016/j.clml.2013.05.004. Epub 2013 Jun 20.
PubMed 23790798Jabbour E, Garcia-Manero G, Ravandi F, Faderl S, O'Brien S, Fullmer A, Cortes JE, Wierda W, Kantarjian H. Prognostic factors associated with disease progression and overall survival in patients with myelodysplastic syndromes treated with decitabine. Clin Lymphoma Myeloma Leuk. 2013 Apr;13(2):131-8. doi: 10.1016/j.clml.2012.11.001. Epub 2012 Dec 21.
PubMed 23260600
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of Decitabine Administered Daily for 5 Days Every 4 Weeks to Adults With Advanced-Stage Myelodysplastic Syndromes
- ClinicalTrials.gov ID
- NCT00260065
- Acronym / sponsor ID
- DACO-020
- Conditions
- Myelodysplastic Syndrome
- Keywords
- Myelodysplastic Syndrome, Decitabine, Dacogen, MGI Pharma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Eisai Inc.Industry (pharma, biotech, devices)
- Study start
- May 2005
- Primary completion
- Jun 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 1 Dec 2005 (estimated)
- Results
- Posted 4 Sep 2009
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 determine the overall response rate in patients with myelodysplastic syndromes (MDS) given a daily dosing schedule of decitabine.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Decitabine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Must sign an Institutional Review Board (IRB) -approved informed consent form.
- Must be 18 years of age or older.
- Must have a diagnosis for MDS fitting any of the recognized French-American-British (FAB) classifications and International Prognostic Scoring System (IPSS) greater than or equal to 0.5 as determined by Complete Blood Count (CBC), bone marrow assessment, and cytogenetics within 28 days of receiving study drug. If FAB classification is Refractory anemia (RA) or Refractory anemia with ringed sideroblasts (RARS), then must be red cell transfusion dependent, defined as needing red cells more frequently than once every 4 weeks.
- If receiving erythropoietin(Procrit), must have been on a stable dose for at least 8 weeks before first dose of study drug.
- If receiving darbepoetin(Aranesp), must have been on a stable dose for at least 12 weeks before first dose of study drug.
Key exclusion criteria (4 listed)
- Must not have a diagnosis of Acute Myeloid Leukemia (AML) or other progressive malignant disease.
- Must not have received any investigational agent within the 30 days preceding the first dose of study drug.
- Must not have uncontrolled cardiac disease or uncontrolled congestive heart failure.
- Must not have an active viral or bacterial infection.
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: Dacogen20mg/m^2, IV on days 1-5 of each 28 day cycle; until progression, death or unacceptable toxicity develops. | Drug | 1 |
Primary outcome
Number of Participants Who Achieved Overall Response
Time frame: 1 year
Overall Response = complete remission (disappearance of all target lesions) + partial remission (at least 30% decrease in the sum of the longest diameters of target lesions)
1 secondary outcome
Best Response and Overall Improvement
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23790798Jabbour E, Kantarjian H, O'Brien S, Kadia T, Malik A, Welch MA, Teng A, Cortes J, Ravandi F, Garcia-Manero G. Retrospective analysis of prognostic factors associated with response and overall survival by baseline marrow blast percentage in patients with myelodysplastic syndromes treated with decitabine. Clin Lymphoma Myeloma Leuk. 2013 Oct;13(5):592-6. doi: 10.1016/j.clml.2013.05.004. Epub 2013 Jun 20.
- Derived from this study: PubMed 23260600Jabbour E, Garcia-Manero G, Ravandi F, Faderl S, O'Brien S, Fullmer A, Cortes JE, Wierda W, Kantarjian H. Prognostic factors associated with disease progression and overall survival in patients with myelodysplastic syndromes treated with decitabine. Clin Lymphoma Myeloma Leuk. 2013 Apr;13(2):131-8. doi: 10.1016/j.clml.2012.11.001. Epub 2012 Dec 21.
- MGI Pharma's websiteLink provided by the sponsor.
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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.
Eisai US Medical Services study director
Eisai Inc.
21 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Decitabine in people with Myelodysplastic Syndrome, run by Eisai Inc. at 21 sites in 2 countries.
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 5 inclusion and 4 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 20 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States, Canada. 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 4 Sep 2009). 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 Who Achieved Overall Response (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00260065, which also lists 2 linked publications.
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 20 May 2013.