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NCT00512252 · ClinicalTrials.gov registry record · Phase 1
AMD3100 Plus Mitoxantrone, Etoposide and Cytarabine in Acute Myeloid Leukemia
A Phase 1 study, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- Phase 1
- Development phase
- 52
- Enrollment target
NCT00512252: Completed Phase 1 study, sponsored by Washington University School of Medicine.
NCT00512252 is a Phase 1 study that has completed, run by Washington University School of Medicine. The registered enrollment target is 52 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (13% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00512252, a Phase 1 study, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 52 participants
- Enrollment target
Study Summary
This study is a phase I/II study to determine the safety and efficacy of AMD3100 when combined with mitoxantrone, etoposide, and cytarabine in patients with relapsed or refractory AML. We hypothesize that disrupting the interaction between AML blasts and the marrow microenvironment with AMD3100 may enhance the cytotoxic effect of chemotherapy.
Primary Outcome
A standard 3+3 design was used in the Phase I portion starting with the AMD3100 dose of 80 mcg/kg and escalating by 80 mcg/kg for each successive cohort up to a maximum of 240 mcg/kg/d. The optimal dose was defined as the highest dose of AMD3100 \<= 240 mcg/kg at which 0-1 of 6 patients experienced a dose limiting toxicity.
Interventions
- DRUG Etoposide
- DRUG Cytarabine
- DRUG Mitoxantrone
- DRUG AMD3100
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2007-07 |
| Est. Completion | 2010-06 |
| Phase | Phase 1 |
What the finished NCT00512252 record still lists
NCT00512252 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (13% lower).
The record links to 0 conditions, and to 4 interventions - of which Etoposide is the first listed.
NCT00512252 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00512252 about?
NCT00512252 is a clinical study titled "AMD3100 Plus Mitoxantrone, Etoposide and Cytarabine in Acute Myeloid Leukemia". This study is a phase I/II study to determine the safety and efficacy of AMD3100 when combined with mitoxantrone, etoposide, and cytarabine in patients with relapsed or refractory AML. We hypothesize that disrupting the interaction between AML blasts and the marrow microenvironment with AMD3100 may...
What is the current status of trial NCT00512252?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 52 participants. The study started on 2007-07. Estimated completion is 2010-06.
What interventions are being tested in trial NCT00512252?
The interventions under investigation include: Etoposide (DRUG), Cytarabine (DRUG), Mitoxantrone (DRUG), AMD3100 (DRUG).
Who is sponsoring clinical trial NCT00512252?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00512252's enrollment target sits among peer trials
52 956th of 2000 higher than 1,032 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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