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NCT00480987 · ClinicalTrials.gov registry record · Phase 1
Oxaliplatin, Fludarabine, and Cytarabine in Acute Myeloid Leukemia (AML) or High-Risk Myelodysplastic Syndromes (MDS)
A Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Terminated
- Registry status
- Phase 1
- Development phase
- 27
- Enrollment target
NCT00480987: Clinical Trial Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT00480987 is a Phase 1 study that was terminated before completion, run by M.D. Anderson Cancer Center. The registered enrollment target is 27 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00480987, a Phase 1 study, was terminated before completion, sponsored by M.D. Anderson Cancer Center.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 27 participants
- Enrollment target
Study Summary
The goal of this clinical research study is to find the highest tolerable dose of oxaliplatin combined with fludarabine plus cytarabine that can be given to patients with Acute Myeloid Leukemia (AML) or High-Risk Myelodysplastic Syndromes (MDS). Once the highest tolerable dose of oxaliplatin in this drug combination is found, the next goal of the study will be to learn the safety and the ability of the drug combination to control the disease.
Primary Outcome
Objective response: Complete Response/Remission (CR) defined as a bone marrow with 5% or fewer blasts and peripheral blood count with an absolute neutrophil count of 10\^9/Liters or more and platelet count of 100\*10\^9/Liters or more; Complete Response with Platelets/remission without platelet recovery (CRp) defined as a complete response except for a platelet less than 100\*10\^9/Liters and transfusion independent; and Partial Response/Remission defined as peripheral blood count recovery as fo
Interventions
- DRUG Fludarabine
- DRUG Oxaliplatin
- DRUG Cytarabine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2007-07 |
| Est. Completion | 2010-08 |
| Phase | Phase 1 |
Why NCT00480987 stopped before completion
NCT00480987 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (55% lower).
The record links to 0 conditions, and to 3 interventions - of which Fludarabine is the first listed.
NCT00480987 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00480987 about?
NCT00480987 is a clinical study titled "Oxaliplatin, Fludarabine, and Cytarabine in Acute Myeloid Leukemia (AML) or High-Risk Myelodysplastic Syndromes (MDS)". The goal of this clinical research study is to find the highest tolerable dose of oxaliplatin combined with fludarabine plus cytarabine that can be given to patients with Acute Myeloid Leukemia (AML) or High-Risk Myelodysplastic Syndromes (MDS). Once the highest tolerable dose of oxaliplatin in this...
What is the current status of trial NCT00480987?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 27 participants. The study started on 2007-07. Estimated completion is 2010-08.
What interventions are being tested in trial NCT00480987?
The interventions under investigation include: Fludarabine (DRUG), Oxaliplatin (DRUG), Cytarabine (DRUG).
Who is sponsoring clinical trial NCT00480987?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00480987's enrollment target sits among peer trials
27 1463rd of 2000 higher than 519 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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