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NCT00413166 · ClinicalTrials.gov registry record · Phase 2
All-trans Retinoic Acid, and Arsenic +/- Idarubicin
A Phase 2 study of Acute Promyelocytic Leukemia, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 78
- Enrollment target
- 1
- Study location
NCT00413166: Completed Phase 2 study of Acute Promyelocytic Leukemia, sponsored by M.D. Anderson Cancer Center.
NCT00413166 is a Phase 2 study of Acute Promyelocytic Leukemia that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 78 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (41% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00413166, a Phase 2 study of Acute Promyelocytic Leukemia, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 78 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this clinical research study is to learn if the combination of arsenic trioxide (ATO) with ATRA and possibly idarubicin is effective in treating patients with newly-diagnosed APL.
Primary Outcome
Response defined as CR (marrow with \<5% blasts and no abnormal promyelocytes together with neutrophil count \>1000 and platelet count \>100,000) and toxicity as Acute promyelocytic leukemia (APL) differentiation syndrome, arrhythmia, peripheral neuropathy. Bone marrow aspirate performed to check the status of the disease.
Conditions Studied
Interventions
- DRUG Gemtuzumab Ozogamicin
- DRUG Idarubicin
- DRUG All-Trans Retinoic Acid (ATRA)
- DRUG Arsenic Trioxide (ATO)
Study Locations (1)
Texas
- University of Texas MD Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 78 participants |
| Start Date | 2006-12 |
| Est. Completion | 2016-02 |
| Phase | Phase 2 |
What the finished NCT00413166 record still lists
NCT00413166 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 78 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (41% lower).
The record links to 1 condition, with Acute Promyelocytic Leukemia appearing as the primary indexed condition, and to 4 interventions - of which Gemtuzumab Ozogamicin is the first listed.
NCT00413166 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT00413166 about?
NCT00413166 is a clinical study titled "All-trans Retinoic Acid, and Arsenic +/- Idarubicin". The goal of this clinical research study is to learn if the combination of arsenic trioxide (ATO) with ATRA and possibly idarubicin is effective in treating patients with newly-diagnosed APL.
What is the current status of trial NCT00413166?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 78 participants. The study started on 2006-12. Estimated completion is 2016-02.
What conditions does trial NCT00413166 study?
This clinical trial studies the following conditions: Acute Promyelocytic Leukemia.
What interventions are being tested in trial NCT00413166?
The interventions under investigation include: Gemtuzumab Ozogamicin (DRUG), Idarubicin (DRUG), All-Trans Retinoic Acid (ATRA) (DRUG), Arsenic Trioxide (ATO) (DRUG).
Who is sponsoring clinical trial NCT00413166?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00413166 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Acute Promyelocytic Leukemia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00413166's enrollment target sits among peer trials
78 884th of 2000 higher than 1,110 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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