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NCT00766116 · ClinicalTrials.gov registry record · Phase 1
Combination 5-azacitidine and Gemtuzumab Ozogamicin Therapy for Treatment of Relapsed Acute Myeloid Leukemia (AML)
A Phase 1 study of Acute Myeloid Leukemia, sponsored by University of California, San Diego.
- Completed
- Registry status
- Phase 1
- Development phase
- 50
- Enrollment target
- 3
- Study locations
NCT00766116: Completed Phase 1 study of Acute Myeloid Leukemia, sponsored by University of California, San Diego.
NCT00766116 is a Phase 1 study of Acute Myeloid Leukemia that has completed, run by University of California, San Diego. The registered enrollment target is 50 participants, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (57% lower). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00766116, a Phase 1 study of Acute Myeloid Leukemia, has completed, sponsored by University of California, San Diego.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 50 participants
- Enrollment target
- 3
- Study locations
Study Summary
This study will test an experimental combination of the drugs Mylotarg and 5-azacitidine in the hopes of finding a treatment that may be effective against Acute Myeloid Leukemia that has come back after treatment.
Primary Outcome
MTD was the maximum number of 5-azacitadine doses (75mg/m2) at which fewer than 1/3 of patients experienced a DLT during cycle 1 of therapy based on CTCAE Version 3.0. In the phase I portion, we assessed 3 dose levels of azacitidine starting on day 1, with 6, 4, and 4 patients in cohort 1, 2, and 3, respectively. We identified no dose-limiting toxicities and identified the phase 2 dose as 75 mg/m2 of 5-azacitadine for 6 days.
Conditions Studied
Interventions
- DRUG 5-Azacitidine
- DRUG Gemtuzumab ozogamicin
Study Locations (3)
California
- UCSD Moores Cancer Center - La Jolla
- Stanford University - Stanford
Georgia
- Northside Hospital/BMTGA - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2005-07 |
| Est. Completion | 2014-09-26 |
| Phase | Phase 1 |
What the finished NCT00766116 record still lists
NCT00766116 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (57% lower).
The record links to 1 condition, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 2 interventions - of which 5-Azacitidine is the first listed.
NCT00766116 reports a single indexed study location in California, Georgia.
Frequently Asked Questions
What is clinical trial NCT00766116 about?
NCT00766116 is a clinical study titled "Combination 5-azacitidine and Gemtuzumab Ozogamicin Therapy for Treatment of Relapsed Acute Myeloid Leukemia (AML)". This study will test an experimental combination of the drugs Mylotarg and 5-azacitidine in the hopes of finding a treatment that may be effective against Acute Myeloid Leukemia that has come back after treatment.
What is the current status of trial NCT00766116?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 50 participants. The study started on 2005-07. Estimated completion is 2014-09-26.
What conditions does trial NCT00766116 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia.
What interventions are being tested in trial NCT00766116?
The interventions under investigation include: 5-Azacitidine (DRUG), Gemtuzumab ozogamicin (DRUG).
Who is sponsoring clinical trial NCT00766116?
This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00766116 being conducted?
This trial has 3 study locations across California, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00766116's enrollment target sits among peer trials
50 143rd of 306 higher than 154 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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