Trial · NCT00513305
Cytarabine in Combination With Arsenic Trioxide vs. Cytarabine Alone in Elderly Patients With Acute Myeloid Leukemia
NCT00513305, Phase 3, Terminated, Cephalon; results first posted 2011-03-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Cytarabine in Combination With Arsenic Trioxide vs. Cytarabine Alone in Elderly Patients With Acute Myeloid Leukemia. Trials, record NCT00513305. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00513305
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Cytarabine in Combination With Arsenic Trioxide vs. Cytarabine Alone in Elderly Patients With Acute Myeloid Leukemia
- NCT number
- NCT00513305
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 67 participants, actual
- Lead sponsor
- Cephalon
- Conditions
- Acute Myeloid Leukemia
- Interventions
- Arsenic trioxide, Low-dose cytarabine alone
- First posted
- 2007-08-08
- Last updated
- 2012-08-01
- Results first posted
- 2011-03-29
- Limitations and caveats
In September 2009, the sponsor decided to stop the study due to difficulty in enrollment. The study was stopped prior to the first planned interim analysis. Most of the analysis planned in the protocol was not performed.
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants in Complete Remission (CR) | From baseline through Day 70. Assessments were performed on Day 21 in cycle 1, no later than Day 56 of cycle 1 or 2 (if applicable), and no later than Day 70 of cycle 1 or 2 (if applicable) or at any other time at the discretion of the investigator | The primary efficacy variable was the percentage of subjects in each treatment group who achieved complete remission after treatment with study drug. Complete remission was defined as: 1) Less than 5% blasts in normocellular bone marrow sample. 2) No blasts in bone marrow sample containing Auer rods. 3)Clearance of previous extramedullary disease. 4)Normal values for absolute neutrophil count (at least 1000/microliter), platelet count (at least 100,000/microliter), without platelet transfusions, and in absence of peripheral myeloblasts. |
| Secondary | Number of Participants Who Died or Were Censored by 24 Months | From Baseline through 24 months following Baseline | This measure (time to death or censor) was defined for all enrolled subjects from the date of randomization until death from any cause. If a subject was not known to have died by the end of the followup period, observation of overall survival was censored on the date the patient was last known to be alive. The number of participants who died or were censored is presented here. (Note: all subjects participating in this study had either died or were censored by 24 months.) |
| Secondary | Proportion of Participants With Relapse-Free Survival (RFS)Using the Kaplan-Meier Estimate | From Baseline (randomization) through 24 months following Baseline | RFS is defined for patients who achieved a complete remission (CR), complete remission with incomplete platelet recovery (CRp), or partial remission(PR), and was measured from the date of attaining CR, CRp, or PR until the date of AML relapse or death from any cause, whichever occurred first. For a patient not known to have relapsed or died by the end of the study followup, observation of relapse free survival was censored on the date of the last followup examination. The Kaplan Meier Estimate of relapse-free survival at Month 3 and Month 6 is presented here. |
| Secondary | Number of Participants Who Experienced Early Death | 14 days from start of study drug treatment | Early death is defined as death from any cause within the first 14 days after start of study drug treatment. The number of patients in each study group who experienced early death is presented here. |
| Secondary | Number of Participants Who Experienced Induction (Thirty-Day) Mortality | Up to 30 days following start of study drug treatment | The number of subjects who died from any cause within the first 30 days after the start of study drug treatment is presented here. |
| Secondary | Proportion of Participants Surviving at 6 Months and 12 Months Using the Kaplan Meier Estimate | Baseline through 12 months | The duration of overall survival was defined for all patients and was measured from the date of randomization until death from any cause. For a patient who was not known to have died by the end of the follow-up period, observation of overall survival was censored on the date the patient was last known to be alive. The estimate of likelihood of survival at 6 and 12 months after Baseline using the Kaplan Meier Estimate is presented here. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants in Complete Remission (CR) | From baseline through Day 70. Assessments were performed on Day 21 in cycle 1, no later than Day 56 of cycle 1 or 2 (if applicable), and no later than Day 70 of cycle 1 or 2 (if applicable) or at any other time at the discretion of the investigator | Intention to treat (ITT) Analysis Set | Percentage of participants in CR | NUMBER |
| SECONDARY | Number of Participants Who Died or Were Censored by 24 Months | From Baseline through 24 months following Baseline | Participants | NUMBER | |
| SECONDARY | Proportion of Participants With Relapse-Free Survival (RFS)Using the Kaplan-Meier Estimate | From Baseline (randomization) through 24 months following Baseline | Population analyzed are the subjects who who achieved a complete remission (CR), complete remission with incomplete platelet recovery (CRp), or partial remission(PR)during the course of the study | Proportion of participants | NUMBER |
| SECONDARY | Number of Participants Who Experienced Early Death | 14 days from start of study drug treatment | Participants | NUMBER | |
| SECONDARY | Number of Participants Who Experienced Induction (Thirty-Day) Mortality | Up to 30 days following start of study drug treatment | Participants | NUMBER | |
| SECONDARY | Proportion of Participants Surviving at 6 Months and 12 Months Using the Kaplan Meier Estimate | Baseline through 12 months | Proportion of Participants | NUMBER |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants in Complete Remission (CR) | Low-dose Cytarabine Plus Arsenic Trioxide | 15.2 | 0.051 to 0.319 | Percentage of participants in CR | |
| Percentage of Participants in Complete Remission (CR) | Low-dose Cytarabine Alone | 8.8 | 0.019 to 0.0237 | Percentage of participants in CR | |
| Number of Participants Who Died or Were Censored by 24 Months | Low-dose Cytarabine Plus Arsenic Trioxide | 33 | Participants | ||
| Number of Participants Who Died or Were Censored by 24 Months | Low-dose Cytarabine Alone | 34 | Participants | ||
| Proportion of Participants With Relapse-Free Survival (RFS)Using the Kaplan-Meier Estimate | Low-dose Cytarabine Plus Arsenic Trioxide | Month 3 (95% Confidence Interval) | 0.818 | 95% Confidence Interval 0.447 to 0.951 | Proportion of participants |
| Proportion of Participants With Relapse-Free Survival (RFS)Using the Kaplan-Meier Estimate | Low-dose Cytarabine Alone | Month 3 (95% Confidence Interval) | 0.800 | 95% Confidence Interval 0.204 to 0.969 | Proportion of participants |
| Proportion of Participants With Relapse-Free Survival (RFS)Using the Kaplan-Meier Estimate | Low-dose Cytarabine Plus Arsenic Trioxide | Month 6 (95% Confidence Interval) | 0.818 | 95% Confidence Interval 0.447 to 0.951 | Proportion of participants |
| Proportion of Participants With Relapse-Free Survival (RFS)Using the Kaplan-Meier Estimate | Low-dose Cytarabine Alone | Month 6 (95% Confidence Interval) | 0.800 | 95% Confidence Interval 0.204 to 0.969 | Proportion of participants |
| Number of Participants Who Experienced Early Death | Low-dose Cytarabine Plus Arsenic Trioxide | 0 | Participants | ||
| Number of Participants Who Experienced Early Death | Low-dose Cytarabine Alone | 2 | Participants |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Low-dose Cytarabine Plus Arsenic Trioxide | 33 | |
| Overall Study | STARTED | Low-dose Cytarabine Alone | 34 | |
| Overall Study | COMPLETED | Low-dose Cytarabine Plus Arsenic Trioxide | 5 | |
| Overall Study | COMPLETED | Low-dose Cytarabine Alone | 7 | |
| Overall Study | NOT COMPLETED | Low-dose Cytarabine Plus Arsenic Trioxide | 28 | |
| Overall Study | NOT COMPLETED | Low-dose Cytarabine Alone | 27 |
Source ClinicalTrials.gov
Adverse events402
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 | Abdominal distension | Gastrointestinal disorders | Low-dose Cytarabine Plus Arsenic Trioxide | 7 | 33 | 7 |
| other | Abdominal distension | Gastrointestinal disorders | Low-dose Cytarabine Alone | 5 | 33 | 5 |
| other | Abdominal pain | Gastrointestinal disorders | Low-dose Cytarabine Plus Arsenic Trioxide | 7 | 33 | 7 |
| other | Abdominal pain | Gastrointestinal disorders | Low-dose Cytarabine Alone | 4 | 33 | 4 |
| other | Abdominal pain lower | Gastrointestinal disorders | Low-dose Cytarabine Plus Arsenic Trioxide | 2 | 33 | 2 |
| other | Abdominal pain lower | Gastrointestinal disorders | Low-dose Cytarabine Alone | 1 | 33 | 1 |
| other | Abdominal pain upper | Gastrointestinal disorders | Low-dose Cytarabine Plus Arsenic Trioxide | 1 | 33 | 1 |
| other | Abdominal pain upper | Gastrointestinal disorders | Low-dose Cytarabine Alone | 4 | 33 | 4 |
| other | Anaemia | Blood and lymphatic system disorders | Low-dose Cytarabine Plus Arsenic Trioxide | 2 | 33 | 2 |
| other | Anaemia | Blood and lymphatic system disorders | Low-dose Cytarabine Alone | 1 | 33 | 1 |
1 to 10 of 402Source ClinicalTrials.gov
See all 402 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Low-dose Cytarabine Plus Arsenic Trioxide | ||
| Total, all-cause mortality | Low-dose Cytarabine Alone | ||
| Total, other adverse events | Low-dose Cytarabine Plus Arsenic Trioxide | 33 | 33 |
| Total, other adverse events | Low-dose Cytarabine Alone | 33 | 33 |
| Total, serious adverse events | Low-dose Cytarabine Plus Arsenic Trioxide | 19 | 33 |
| Total, serious adverse events | Low-dose Cytarabine Alone | 21 | 33 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Low-dose Cytarabine Plus Arsenic Trioxide vs Low-dose Cytarabine Alone: Number of Participants Who Experienced Early Death | Trial comparisons |
| Low-dose Cytarabine Plus Arsenic Trioxide vs Low-dose Cytarabine Alone: Number of Participants Who Died or Were Censored by 24 Months | Trial comparisons |
| Low-dose Cytarabine Plus Arsenic Trioxide vs Low-dose Cytarabine Alone: Number of Participants Who Experienced Induction (Thirty-Day) Mortality | Trial comparisons |
| Low-dose Cytarabine Plus Arsenic Trioxide vs Low-dose Cytarabine Alone: serious adverse events | 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/NCT00513305
GET https://conductscience.org/api/trials/v1/NCT00513305/events?page=2