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NCT00274781 · ClinicalTrials.gov registry record · Phase 2
Arsenic Trioxide and Gemtuzumab Ozogamicin in Treating Patients With Advanced Myelodysplastic Syndromes
A Phase 2 study, sponsored by The Cleveland Clinic.
- Completed
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
NCT00274781: Completed Phase 2 study, sponsored by The Cleveland Clinic.
NCT00274781 is a Phase 2 study that has completed, run by The Cleveland Clinic. The registered enrollment target is 30 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00274781, a Phase 2 study, has completed, sponsored by The Cleveland Clinic.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
Study Summary
RATIONALE: Drugs used in chemotherapy, such as arsenic trioxide and gemtuzumab ozogamicin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving arsenic trioxide together with gemtuzumab ozogamicin works in treating patients with advanced myelodysplastic syndromes.
Primary Outcome
The null hypothesis to be tested was the percentage who will respond to combination arsenic trioxide (ATO) and gemtuzumab ozogamicin (GO) therapy is \<10%. A total of \>/= 9 responses observed in 30 evaluable patients was taken as evidence warranting further study of the regimen, provided the toxicity profile also appears favorable. The IWG Criteria standardizes the clinical responses in MDS and AML based upon hematologic improvement, quality of life and cytogenic improvement. These standardizat
Interventions
- DRUG gemtuzumab ozogamicin
- DRUG arsenic trioxide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2004-02 |
| Est. Completion | 2010-11 |
| Phase | Phase 2 |
What the finished NCT00274781 record still lists
NCT00274781 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 2 interventions - of which gemtuzumab ozogamicin is the first listed.
NCT00274781 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00274781 about?
NCT00274781 is a clinical study titled "Arsenic Trioxide and Gemtuzumab Ozogamicin in Treating Patients With Advanced Myelodysplastic Syndromes". RATIONALE: Drugs used in chemotherapy, such as arsenic trioxide and gemtuzumab ozogamicin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. PURPO...
What is the current status of trial NCT00274781?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2004-02. Estimated completion is 2010-11.
What interventions are being tested in trial NCT00274781?
The interventions under investigation include: gemtuzumab ozogamicin (DRUG), arsenic trioxide (DRUG).
Who is sponsoring clinical trial NCT00274781?
This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00274781's enrollment target sits among peer trials
30 1582nd of 2000 higher than 332 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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