Acute Myeloid LeukemiaPhase 3NCT00260832
Trial of Decitabine in Patients With Acute Myeloid Leukemia
A Phase 3 study testing Cytarabine or Supportive Care and Dacogen (decitabine) only in people with Acute Myeloid Leukemia, run by Eisai Inc. at 108 sites in 15 countries.
Trial summary
The purpose of this study is to compare the results in older patients who have newly diagnosed or secondary acute myeloid leukemia (AML) and who are to either receive decitabine or patient's choice with the physician's advice of either cytarabine or supportive care medication. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- Cytarabine or Supportive Care and Dacogen (decitabine) only
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 485 participants
- Where
- 108 sitesin 15 countries
- Study dates
- Nov 2005to Dec 2010
- Phase
- Phase 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Must have diagnosed acute myeloid leukemia.
- Must have a life expectancy of at least 12 weeks.
- Must sign informed consent.
Who cannot join
- Must not have acute promyelocytic leukemia (M3 classification)
- Must not have any other active systemic malignancies.
- Must not have inaspirable bone marrow.
- Must not have received previous chemotherapy (except hydroxyurea) for any myeloid disorder.
- Must not have chronic respiratory disease that requires continuous oxygen use.
- Must not have received any experimental drug within 4 weeks before randomization.
- Must not be a candidate for a bone marrow or stem cell transplant within 12 weeks after randomization.
- Must not have known HIV.
Trial locations and contacts
108 sites in 15 countries.
108 sites in 15 countries
United States37 sites
Study site
Austin, Texas, 78705
Study site
Baton Rouge, Louisiana
Study site
Boston, Massachusetts
Study site
Canton, Ohio, 44710
Study site
Charleston, South Carolina, 29406
Study site
Chicago, Illinois, 60612
Study site
Cincinnati, Ohio, 45267
Study site
Durham, North Carolina, 27710
Study site
Eau Claire, Wisconsin
Study site
Fort Myers, Florida, 33901
Study site
Gainesville, Florida, 32610
Study site
Galveston, Texas, 77555
Study site
Glendale, Wisconsin, 53212
Study site
Greenville, South Carolina
Study site
Grosse Pointe Woods, Michigan, 48236
Study site
Highland Park, Illinois
Study site
Hollywood, Florida
Study site
Houston, Texas, 77030
Study site
Kalamazoo, Michigan, 49048
Study site
Knoxville, Tennessee, 37920
Study site
Lakeland, Florida, 33805
Study site
Los Angeles, California
Study site
Miami, Florida
Study site
Milwaukee, Wisconsin
Study site
Nashville, Tennessee
Study site
Neptune City, New Jersey
Study site
New York, New York
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Orange Park, Florida, 32073
Study site
Pittsburgh, Pennsylvania, 15232
Study site
Shreveport, Louisiana
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Sioux City, Iowa, 51101
Study site
Sioux Falls, South Dakota, 57105
Study site
Springfield, Massachusetts, 01107
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Temple, Texas
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Terre Haute, Indiana, 47804
Study site
Valhalla, New York, 10595
Study site
Wichita, Kansas, 67214
Russia15 sites
Study site
Arkhangelsk
Study site
Astrakhan
Study site
Barnaul
Study site
Izhevsk
Study site
Kirov
Study site
Kransnodar
Study site
Moscow
Study site
Novosibirsk
Study site
Petrozavodsk
Study site
Ryazan
Study site
Saint Petersburg
Study site
Samara
Study site
Saratov
Study site
Tyumen
Study site
Volgograd
Spain8 sites
Study site
Badalona-Barcelona, 08916
Study site
Barcelona, 08035
Study site
Girona
Study site
Madrid, 28006
Study site
Palma de Mallorca, 07014
Study site
Pamplona, 31008
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Salamanca
Study site
Valencia
Australia7 sites
Study site
Adelaide, South Australia
Study site
Darlinghurst, New South Wales
Study site
East Melbourne, Victoria, 3002
Study site
Parkville, Victoria, 3052
Study site
Perth, Western Australia, 6000
Study site
South Brisbane, Queensland, 4101
Study site
St Leonards, New South Wales, 2065
France7 sites
Study site
Bobigny, 93009
Study site
Créteil
Study site
Lille, 59037
Study site
Limoges
Study site
Lyon, 69437
Study site
Nantes, 44000
Study site
Pessac
Poland7 sites
Study site
Gdansk
Study site
Krakow
Study site
Lodz, 93-510
Study site
Lublin, 20-081
Study site
Poznan
Study site
Warsaw
Study site
Wroclaw, 50-367
Hungary5 sites
Study site
Budapest
Study site
Győr, 9024
Study site
Gyula, 5700
Study site
Szeged
Study site
Szombathely
Czechia4 sites
Study site
Brno, 62500
Study site
České Budějovice
Study site
Pilsen
Study site
Prague, 128 08
Taiwan4 sites
Study site
Changhua
Study site
Kaohsiung City
Study site
Tainan, 70403
Study site
Taipei, 10449
Canada3 sites
Study site
Halifax, Nova Scotia, B3H 2Y9
Study site
St. John's, Newfoundland and Labrador, AiB 3V6
Study site
Toronto, Ontario, M4N 3M5
Romania3 sites
Study site
Bucharest
Study site
Cluj-Napoca, 400124
Study site
Târgu Mureş, 540042
Serbia3 sites
Study site
Belgrade, 11000
Study site
Niš
Study site
Novi Sad, 21000
About this study
Official title: Randomized Phase 3 Trial of Decitabine Versus Patient's Choice With Physician's Advice of Either Supportive Care or Low-Dose Cytarabine for the Treatment of Older Patients With Newly Diagnosed Acute Myeloid Leukemia
The purpose of this study is to compare the results in older patients who have newly diagnosed or secondary acute myeloid leukemia (AML) and who are to either receive decitabine or patient's choice with the physician's advice of either cytarabine or supportive care medication.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- Cytarabine or Supportive Care, Dacogen (decitabine) only
- Keywords
- Acute Myeloid Leukemia, Dacogen, Decitabine, Poor or intermediate-risk cytogenetics
- 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.
Cytarabine or Supportive CareDrug
Patient's choice with physician's advice of either supportive care (IV fluids, nutrition, and antibiotics as needed) or cytarabine 20 mg/m^2 subcutaneously once daily for the first 10 consecutive days of each 28 day cycle, until progression or unacceptable toxicity develops. (These represent one intervention.)
Dacogen (decitabine) onlyDrug
Also called decitabine
20mg/m^2, 1 hour intravenous (IV) for 5 consecutive days of each 28 day cycle. Cycles continue until disease progression or unacceptable toxicity develops.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Subject's choice of treatment with physician's advice. Subjects preselected their preference of supportive care (including IV fluids, nutrition, and antibiotics) or cytarabine. (These represent one intervention.) Receives: Drug: Cytarabine or Supportive Care |
| B | Active comparator | Not described Receives: Drug: Dacogen (decitabine) only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival in Patients 65 Years or Older Who Have Newly Diagnosed de Novo or Secondary AML.
The interval from date of randomization to the date of death from any cause or the last date the subject was known to be alive or 5 years whichever occurs first.
Measured: The interval from date of randomization to the date of death from any cause or the last date the subject was known to be alive or 5 years whichever occurs first.
Secondary outcomes (1)
Percentage of Participants With Complete Remission (CR) Plus Complete Remission With Incomplete Platelet Recovery (CRp)
Morphologic CR plus CRp rate where Morphologic leukemia-free state defined as less that (<) 5 percent (%) blasts in an aspirate sample with marrow spicules and a count of greater than or equal to (>=) 200 nucleated cells (there should have been no blasts with Auer rods or persistence of extramedullary disease) plus absolute neutrophil count (ANC) greater than (>)1,000 per microliter (/mcL), platelet count of >=100,000/mcL, and the participant must have been independent of transfusions for at least 1 week before each assessment. There was no duration requirement for confirmation of this designation and Morphologic CR without the requirement of platelet count >=100,000/mcL.
Measured: Post randomization when at least one post-baseline bone marrow assessment or peripheral blood count data available (up to 29.5 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2005 (estimated)
- Study startNov 2005
- Primary completionOct 2009
- Study completionDec 2010
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 (1)Papers the sponsor has linked to this study.
- Other trials for Acute Myeloid LeukemiaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 485 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eisai Medical Services, Study director, Eisai Global Clinical Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00260832
- Sponsor's protocol ID
- DACO-016
- Status last verified
- Sep 2011
- First submitted
- 1 Dec 2005
- Last updated
- 11 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Mayer J, Arthur C, Delaunay J, Mazur G, Thomas XG, Wierzbowska A, Ravandi F, Berrak E, Jones M, Li Y, Kantarjian HM. Multivariate and subgroup analyses of a randomized, multinational, phase 3 trial of decitabine vs treatment choice of supportive care or cytarabine in older patients with newly diagnosed acute myeloid leukemia and poor- or intermediate-risk cytogenetics. BMC Cancer. 2014 Feb 6;14:69. doi: 10.1186/1471-2407-14-69.
PubMed 24498872
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase 3 Trial of Decitabine Versus Patient's Choice With Physician's Advice of Either Supportive Care or Low-Dose Cytarabine for the Treatment of Older Patients With Newly Diagnosed Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT00260832
- Acronym / sponsor ID
- DACO-016
- Conditions
- Acute Myeloid Leukemia
- Keywords
- Acute Myeloid Leukemia, Dacogen, Decitabine, Poor or intermediate-risk cytogenetics
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 485 participants (actual)
- Lead sponsor
- Eisai Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2005
- Primary completion
- Oct 2009 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 2 Dec 2005 (estimated)
- Results
- Posted 21 Sep 2011
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 compare the results in older patients who have newly diagnosed or secondary acute myeloid leukemia (AML) and who are to either receive decitabine or patient's choice with the physician's advice of either cytarabine or supportive care medication.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Cytarabine or Supportive CareSubject's choice of treatment with physician's advice. Subjects preselected their preference of supportive care (including IV fluids, nutrition, and antibiotics) or cytarabine. (These represent one intervention.) |
| B | Active comparator | Drug: Dacogen (decitabine) only |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Must have diagnosed acute myeloid leukemia.
- Must have a life expectancy of at least 12 weeks.
- Must sign informed consent.
Key exclusion criteria (8 listed)
- Must not have acute promyelocytic leukemia (M3 classification)
- Must not have any other active systemic malignancies.
- Must not have inaspirable bone marrow.
- Must not have received previous chemotherapy (except hydroxyurea) for any myeloid disorder.
- Must not have chronic respiratory disease that requires continuous oxygen use.
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 |
|---|---|---|
| Cytarabine or Supportive CarePatient's choice with physician's advice of either supportive care (IV fluids, nutrition, and antibiotics as needed) or cytarabine 20 mg/m^2 subcutaneously once daily for the first 10 consecutive days of each 28 day cycle, until progression or unacceptable toxicity develops. (These represent one intervention.) | Drug | A |
| Dacogen (decitabine) onlyAlso: decitabine20mg/m^2, 1 hour intravenous (IV) for 5 consecutive days of each 28 day cycle. Cycles continue until disease progression or unacceptable toxicity develops. | Drug | B |
Primary outcome
Overall Survival in Patients 65 Years or Older Who Have Newly Diagnosed de Novo or Secondary AML.
Time frame: The interval from date of randomization to the date of death from any cause or the last date the subject was known to be alive or 5 years whichever occurs first.
The interval from date of randomization to the date of death from any cause or the last date the subject was known to be alive or 5 years whichever occurs first.
1 secondary outcome
Percentage of Participants With Complete Remission (CR) Plus Complete Remission With Incomplete Platelet Recovery (CRp)
Time frame: Post randomization when at least one post-baseline bone marrow assessment or peripheral blood count data available (up to 29.5 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24498872Mayer J, Arthur C, Delaunay J, Mazur G, Thomas XG, Wierzbowska A, Ravandi F, Berrak E, Jones M, Li Y, Kantarjian HM. Multivariate and subgroup analyses of a randomized, multinational, phase 3 trial of decitabine vs treatment choice of supportive care or cytarabine in older patients with newly diagnosed acute myeloid leukemia and poor- or intermediate-risk cytogenetics. BMC Cancer. 2014 Feb 6;14:69. doi: 10.1186/1471-2407-14-69.
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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 Medical Services study director
Eisai Global Clinical Development
108 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cytarabine or Supportive Care and Dacogen (decitabine) only in people with Acute Myeloid Leukemia, run by Eisai Inc. at 108 sites in 15 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 3 inclusion and 8 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 11 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 108 sites in United States, Russia, Spain, Australia, France and 10 more countries. 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 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 21 Sep 2011). 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?
Overall Survival in Patients 65 Years or Older Who Have Newly Diagnosed de Novo or Secondary AML. (time frame: The interval from date of randomization to the date of death from any cause or the last date the subject was known to be alive or 5 years whichever occurs first.). 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 NCT00260832, which also lists 1 linked publication.
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 11 Sep 2019.