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NCT00583102 · ClinicalTrials.gov registry record · Phase 1
Dose Escalation Phase I/II Study of Lovastatin With High-Dose Cytarabine for Refractory or Relapsed AML
A Phase 1 study, sponsored by University of Iowa.
- Terminated
- Registry status
- Phase 1
- Development phase
- 23
- Enrollment target
NCT00583102: Clinical Trial Phase 1 study, sponsored by University of Iowa.
NCT00583102 is a Phase 1 study that was terminated before completion, run by University of Iowa. The registered enrollment target is 23 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00583102, a Phase 1 study, was terminated before completion, sponsored by University of Iowa.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 23 participants
- Enrollment target
Study Summary
The purpose of this study is to test the safety and effectiveness of combining a drug known as Lovastatin to the chemotherapy drug cytarabine. Lovastatin is currently used to lower blood cholesterol levels and lab data suggests that it increases the anti-leukemia activity of cytarabine. This research is being done because high doses of cytarabine induce remissions in only about 25% of patients with acute myeloid leukemia.
Primary Outcome
The primary study end point will be complete remission rate. Complete Remission (CR): Complete remission is defined as the presence of all of the following: Peripheral Blood Counts (sustained \> 30 days) * Absolute neutrophil count ³1500/ml. * Platelet count ³100,000/ml. * No leukemic blasts in the peripheral blood. * Transfusion independent for red cells and platelets. Bone Marrow * Cellularity \>20% with maturation of all cell lines. * No Auer rods. * \<5% blast cells. No extramedullary le
Interventions
- DRUG Cytarabine
- DRUG Lovastatin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2001-06 |
| Est. Completion | 2013-06 |
| Phase | Phase 1 |
Why NCT00583102 stopped before completion
NCT00583102 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 2 interventions - of which Cytarabine is the first listed.
NCT00583102 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00583102 about?
NCT00583102 is a clinical study titled "Dose Escalation Phase I/II Study of Lovastatin With High-Dose Cytarabine for Refractory or Relapsed AML". The purpose of this study is to test the safety and effectiveness of combining a drug known as Lovastatin to the chemotherapy drug cytarabine. Lovastatin is currently used to lower blood cholesterol levels and lab data suggests that it increases the anti-leukemia activity of cytarabine. This researc...
What is the current status of trial NCT00583102?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 23 participants. The study started on 2001-06. Estimated completion is 2013-06.
What interventions are being tested in trial NCT00583102?
The interventions under investigation include: Cytarabine (DRUG), Lovastatin (DRUG).
Who is sponsoring clinical trial NCT00583102?
This trial is sponsored by University of Iowa, which has 228 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00583102's enrollment target sits among peer trials
23 1596th of 2000 higher than 400 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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