Trial · NCT00260832
Trial of Decitabine in Patients With Acute Myeloid Leukemia
NCT00260832, Phase 3, Completed, Eisai Inc.; results first posted 2011-09-21
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Trial of Decitabine in Patients With Acute Myeloid Leukemia. Trials, record NCT00260832. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00260832
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trial of Decitabine in Patients With Acute Myeloid Leukemia
- NCT number
- NCT00260832
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 485 participants, actual
- Lead sponsor
- Eisai Inc.
- Conditions
- Acute Myeloid Leukemia
- Interventions
- Cytarabine or Supportive Care, Dacogen (decitabine) only
- First posted
- 2005-12-02
- Last updated
- 2019-09-11
- Results first posted
- 2011-09-21
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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. | 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 | Percentage of Participants With Complete Remission (CR) Plus Complete Remission With Incomplete Platelet Recovery (CRp) | Post randomization when at least one post-baseline bone marrow assessment or peripheral blood count data available (up to 29.5 months) | 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. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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. | The primary population for all efficacy analyses was the Intent-to-treat (ITT) population defined as all subjects randomly allocated to a treatment arm. | months | MEDIAN |
| SECONDARY | Percentage of Participants With Complete Remission (CR) Plus Complete Remission With Incomplete Platelet Recovery (CRp) | Post randomization when at least one post-baseline bone marrow assessment or peripheral blood count data available (up to 29.5 months) | The primary population for all efficacy analyses was the ITT population defined as all participant randomly allocated to a treatment arm. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival in Patients 65 Years or Older Who Have Newly Diagnosed de Novo or Secondary AML. | Cytarabine or Supportive Care | 5.0 | Full Range 4.3 to 6.3 | months | |
| Overall Survival in Patients 65 Years or Older Who Have Newly Diagnosed de Novo or Secondary AML. | Dacogen (Decitabine) Only | 7.7 | Full Range 6.2 to 9.2 | months | |
| Percentage of Participants With Complete Remission (CR) Plus Complete Remission With Incomplete Platelet Recovery (CRp) | Cytarabine or Supportive Care | 7.8 | percentage of participants | ||
| Percentage of Participants With Complete Remission (CR) Plus Complete Remission With Incomplete Platelet Recovery (CRp) | Dacogen (Decitabine) Only | 17.8 | percentage of participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cytarabine or Supportive Care | 243 | |
| Overall Study | STARTED | Dacogen (Decitabine) Only | 242 | |
| Overall Study | COMPLETED | Cytarabine or Supportive Care | 15 | |
| Overall Study | COMPLETED | Dacogen (Decitabine) Only | 31 | |
| Overall Study | NOT COMPLETED | Cytarabine or Supportive Care | 228 | |
| Overall Study | NOT COMPLETED | Dacogen (Decitabine) Only | 211 |
Source ClinicalTrials.gov
Adverse events42
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Pyrexia | General disorders | Cytarabine or Supportive Care | 88 | 237 | |
| other | Pyrexia | General disorders | Dacogen (Decitabine) Only | 114 | 238 | |
| other | Disease Progression | General disorders | Cytarabine or Supportive Care | 59 | 237 | |
| other | Disease Progression | General disorders | Dacogen (Decitabine) Only | 55 | 238 | |
| other | Peripheral Edema | General disorders | Cytarabine or Supportive Care | 42 | 237 | |
| other | Peripheral Edema | General disorders | Dacogen (Decitabine) Only | 50 | 238 | |
| other | Pneumonia | Infections and infestations | Cytarabine or Supportive Care | 50 | 237 | |
| other | Pneumonia | Infections and infestations | Dacogen (Decitabine) Only | 58 | 238 | |
| other | Urinary Tract Infection | Infections and infestations | Cytarabine or Supportive Care | 14 | 237 | |
| other | Urinary Tract Infection | Infections and infestations | Dacogen (Decitabine) Only | 35 | 238 |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cytarabine or Supportive Care | ||
| Total, all-cause mortality | Dacogen (Decitabine) Only | ||
| Total, other adverse events | Cytarabine or Supportive Care | 231 | 237 |
| Total, other adverse events | Dacogen (Decitabine) Only | 237 | 238 |
| Total, serious adverse events | Cytarabine or Supportive Care | 162 | 237 |
| Total, serious adverse events | Dacogen (Decitabine) Only | 190 | 238 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 24498872 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Cytarabine or Supportive Care vs Dacogen (Decitabine) Only: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00260832
GET https://conductscience.org/api/trials/v1/NCT00260832/events?page=2