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NCT01074047 · ClinicalTrials.gov registry record · Phase 3
Study of Vidaza Versus Conventional Care Regimens for the Treatment of Acute Myeloid Leukemia (AML)
A Phase 3 study of Acute Myeloid Leukemia, sponsored by Celgene.
- Completed
- Registry status
- Phase 3
- Development phase
- 488
- Enrollment target
- 20
- Study locations
NCT01074047: Completed Phase 3 study of Acute Myeloid Leukemia, sponsored by Celgene.
NCT01074047 is a Phase 3 study of Acute Myeloid Leukemia that has completed, run by Celgene. The registered enrollment target is 488 participants, above the 114-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (328% higher). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01074047, a Phase 3 study of Acute Myeloid Leukemia, has completed, sponsored by Celgene.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 488 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to compare the effect of azacitidine (Vidaza) to conventional care regimens on overall survival in elderly AML patients.
Primary Outcome
Overall Survival was defined as the time from randomization to death from any cause. Overall survival was calculated by the formula: date of death - date of randomization + 1. Participants surviving at the end of the follow-up period or who withdrew consent to follow-up were censored at the date of last contact. Participants who were lost to follow-up were censored at the date last known alive.
Conditions Studied
Interventions
- DRUG Azacitidine
- DRUG Conventional Care Regimen
Study Locations (20)
Victoria
- Peter MacCallum Cancer Centre - East Melbourne
- Western Hospital - Footscray
- Royal Melbourne Hospital - Melbourne
Other
- St Vincent's Hospital - Fitzroy
- Landeskliniken Salzburg Saint Johanns-Spital, III Medizinische Abteilung - Salzburg
- Centre Hospitalier de Jolimont-Lobbes - La Louvière
Massachusetts
- Massachusetts General Hospital - Boston
Texas
- MD Anderson Cancer Center - Houston
New South Wales
- Prince of Wales Hospital - Randwick
South Australia
- Royal Adelaide Hospital - Adelaide
Upper Austria
- Klinikum Wels-Grieskirchen GmbH - Wels
Vienna
- Wilhelminenspital, I Medizinische Abt. - Vienna
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 488 participants |
| Start Date | 2010-06-01 |
| Est. Completion | 2016-07-25 |
| Phase | Phase 3 |
What the finished NCT01074047 record still lists
NCT01074047 is an interventional study that assigns participants to a tested intervention. The registered 488 participants enrollment target is mid-sized for trials with a published cap, above the 114-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (328% higher).
The record links to 1 condition, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 2 interventions - of which Azacitidine is the first listed.
NCT01074047 names 20 study sites across 16 states, led by Victoria, Other, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT01074047 about?
NCT01074047 is a clinical study titled "Study of Vidaza Versus Conventional Care Regimens for the Treatment of Acute Myeloid Leukemia (AML)". The purpose of this study is to compare the effect of azacitidine (Vidaza) to conventional care regimens on overall survival in elderly AML patients.
What is the current status of trial NCT01074047?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 488 participants. The study started on 2010-06-01. Estimated completion is 2016-07-25.
What conditions does trial NCT01074047 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia.
What interventions are being tested in trial NCT01074047?
The interventions under investigation include: Azacitidine (DRUG), Conventional Care Regimen (DRUG).
Who is sponsoring clinical trial NCT01074047?
This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01074047 being conducted?
This trial has 20 study locations across Massachusetts, Texas, New South Wales, South Australia, Victoria. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01074047's enrollment target sits among peer trials
488 10th of 306 higher than 297 of 306 other Acute Myeloid Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Myeloid Leukemia 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.
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