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NCT00513305 · ClinicalTrials.gov registry record · Phase 3
Cytarabine in Combination With Arsenic Trioxide vs. Cytarabine Alone in Elderly Patients With Acute Myeloid Leukemia
A Phase 3 study, sponsored by Cephalon.
- Terminated
- Registry status
- Phase 3
- Development phase
- 67
- Enrollment target
NCT00513305: Clinical Trial Phase 3 study, sponsored by Cephalon.
NCT00513305 is a Phase 3 study that was terminated before completion, run by Cephalon. The registered enrollment target is 67 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00513305, a Phase 3 study, was terminated before completion, sponsored by Cephalon.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 67 participants
- Enrollment target
Study Summary
The primary objective of this study is to determine whether low-dose cytarabine in combination with arsenic trioxide is more effective than low-dose cytarabine alone in achieving complete remission in elderly patients (≥60 years of age) with acute myeloid leukemia.
Primary Outcome
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,
Interventions
- DRUG Arsenic trioxide
- DRUG Low-dose cytarabine alone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 67 participants |
| Start Date | 2007-10 |
| Est. Completion | 2009-12 |
| Phase | Phase 3 |
Why NCT00513305 stopped before completion
NCT00513305 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 67 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 2 interventions - of which Arsenic trioxide is the first listed.
NCT00513305 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00513305 about?
NCT00513305 is a clinical study titled "Cytarabine in Combination With Arsenic Trioxide vs. Cytarabine Alone in Elderly Patients With Acute Myeloid Leukemia". The primary objective of this study is to determine whether low-dose cytarabine in combination with arsenic trioxide is more effective than low-dose cytarabine alone in achieving complete remission in elderly patients (≥60 years of age) with acute myeloid leukemia.
What is the current status of trial NCT00513305?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 67 participants. The study started on 2007-10. Estimated completion is 2009-12.
What interventions are being tested in trial NCT00513305?
The interventions under investigation include: Arsenic trioxide (DRUG), Low-dose cytarabine alone (DRUG).
Who is sponsoring clinical trial NCT00513305?
This trial is sponsored by Cephalon, which has 64 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00513305's enrollment target sits among peer trials
67 1796th of 2000 higher than 204 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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