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NCT00839982 · ClinicalTrials.gov registry record · Phase 1
Clofarabine and Cytarabine in Treating Older Patients With AML or High-Risk MDS
A Phase 1 study, sponsored by Fred Hutchinson Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 35
- Enrollment target
NCT00839982: Completed Phase 1 study, sponsored by Fred Hutchinson Cancer Center.
NCT00839982 is a Phase 1 study that has completed, run by Fred Hutchinson Cancer Center. The registered enrollment target is 35 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (42% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00839982, a Phase 1 study, has completed, sponsored by Fred Hutchinson Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 35 participants
- Enrollment target
Study Summary
This phase I/II trial studied the side effects and best dose of clofarabine when given together with cytarabine and to see how well they work in treating older patients with acute myeloid leukemia (AML) or high-risk myelodysplastic syndromes (MDS) that have relapsed or not responded to treatment.
Primary Outcome
Dose limiting toxicity (DLT) consists of grade 3-4 non-hematologic toxicity at least possibly related to study drug. Exceptions include neutropenic fever; drug-related fever; alopecia; anorexia; inadequately treated nausea, vomiting and/or diarrhea; and grade 3/4 increase in ALT, AST, or bilirubin recovering to \< grade 2 by 7 days. Prolonged grade 2 myelosuppression lasting longer than 49 days in patients who don't proceed to additional cytotoxic therapy is considered a DLT. The MTD or recommen
Interventions
- DRUG clofarabine
- DRUG cytarabine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2008-11 |
| Est. Completion | 2012-12 |
| Phase | Phase 1 |
What the finished NCT00839982 record still lists
NCT00839982 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (42% lower).
The record links to 0 conditions, and to 2 interventions - of which clofarabine is the first listed.
NCT00839982 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00839982 about?
NCT00839982 is a clinical study titled "Clofarabine and Cytarabine in Treating Older Patients With AML or High-Risk MDS". This phase I/II trial studied the side effects and best dose of clofarabine when given together with cytarabine and to see how well they work in treating older patients with acute myeloid leukemia (AML) or high-risk myelodysplastic syndromes (MDS) that have relapsed or not responded to treatment.
What is the current status of trial NCT00839982?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 35 participants. The study started on 2008-11. Estimated completion is 2012-12.
What interventions are being tested in trial NCT00839982?
The interventions under investigation include: clofarabine (DRUG), cytarabine (DRUG).
Who is sponsoring clinical trial NCT00839982?
This trial is sponsored by Fred Hutchinson Cancer Center, which has 483 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00839982's enrollment target sits among peer trials
35 1258th of 2000 higher than 728 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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