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NCT01303796 · ClinicalTrials.gov registry record · Phase 3
A Study of Oral Sapacitabine in Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia
A Phase 3 study, sponsored by Cyclacel Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 482
- Enrollment target
NCT01303796: Completed Phase 3 study, sponsored by Cyclacel Pharmaceuticals.
NCT01303796 is a Phase 3 study that has completed, run by Cyclacel Pharmaceuticals. The registered enrollment target is 482 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (38% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01303796, a Phase 3 study, has completed, sponsored by Cyclacel Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 482 participants
- Enrollment target
Study Summary
This Phase 3 study assesses two drug regimens as the initial treatment of patients who are at least 70 years of age and have newly diagnosed acute myeloid leukemia (AML) for whom the doctor does not recommend the use of standard intensive treatment or the patient has decided not to receive standard intensive treatment after being fully informed about its benefits and risks by his/her doctor. The two drug regimens are sapacitabine administered in alternating cycles with decitabine or decitabine alone. The purpose of the study is to learn which drug regimen is more likely to keep AML in check as long as possible.
Primary Outcome
The distribution of overall survival was estimated by the method of Kaplan and Meier. A log-rank analysis stratified by randomization stratification factors was used to compare overall survival between Arm A (decitabine/sapacitabine) versus Arm C (decitabine). Cox proportional hazards models were used to identify predictive factors for overall survival.
Interventions
- DRUG Decitabine
- DRUG Sapacitabine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 482 participants |
| Start Date | 2011-10-01 |
| Est. Completion | 2017-07-31 |
| Phase | Phase 3 |
What the finished NCT01303796 record still lists
NCT01303796 is an interventional study that assigns participants to a tested intervention. The registered 482 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (38% lower).
The record links to 0 conditions, and to 2 interventions - of which Decitabine is the first listed.
NCT01303796 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01303796 about?
NCT01303796 is a clinical study titled "A Study of Oral Sapacitabine in Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia". This Phase 3 study assesses two drug regimens as the initial treatment of patients who are at least 70 years of age and have newly diagnosed acute myeloid leukemia (AML) for whom the doctor does not recommend the use of standard intensive treatment or the patient has decided not to receive standard ...
What is the current status of trial NCT01303796?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 482 participants. The study started on 2011-10-01. Estimated completion is 2017-07-31.
What interventions are being tested in trial NCT01303796?
The interventions under investigation include: Decitabine (DRUG), Sapacitabine (DRUG).
Who is sponsoring clinical trial NCT01303796?
This trial is sponsored by Cyclacel Pharmaceuticals, which has 13 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01303796's enrollment target sits among peer trials
482 792nd of 2000 higher than 1,209 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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