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NCT00268242 · ClinicalTrials.gov registry record · Phase 2
Gemcitabine and Mitoxantrone in Treating Patients With Relapsed Acute Myeloid Leukemia
A Phase 2 study, sponsored by The Cleveland Clinic.
- Terminated
- Registry status
- Phase 2
- Development phase
- 24
- Enrollment target
NCT00268242: Clinical Trial Phase 2 study, sponsored by The Cleveland Clinic.
NCT00268242 is a Phase 2 study that was terminated before completion, run by The Cleveland Clinic. The registered enrollment target is 24 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00268242, a Phase 2 study, was terminated before completion, sponsored by The Cleveland Clinic.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 24 participants
- Enrollment target
Study Summary
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and mitoxantrone, 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 gemcitabine together with mitoxantrone works in treating patients with relapsed acute myeloid leukemia.
Primary Outcome
Assumptions/ hypothesis: A Complete Response (CR) rate of 30% or less is unacceptable, and 50% or more is promising. A two-stage design will be used. Initially, 18 patients will be enrolled. If 5 or fewer achieve CR, the study will be stopped. Otherwise, an additional 22 patients will be accrued. Accrual was not halted while follow-up of the first 18 evaluable patients was under way. Therefore, 24 patients were enrolled. Four weeks is anticipated for observation for response. Only 5 patients (21
Interventions
- DRUG Gemcitabine Hydrochloride
- DRUG Mitoxantrone Hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2006-01 |
| Est. Completion | 2011-07 |
| Phase | Phase 2 |
Why NCT00268242 stopped before completion
NCT00268242 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 2 interventions - of which Gemcitabine Hydrochloride is the first listed.
NCT00268242 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00268242 about?
NCT00268242 is a clinical study titled "Gemcitabine and Mitoxantrone in Treating Patients With Relapsed Acute Myeloid Leukemia". RATIONALE: Drugs used in chemotherapy, such as gemcitabine and mitoxantrone, 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...
What is the current status of trial NCT00268242?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 24 participants. The study started on 2006-01. Estimated completion is 2011-07.
What interventions are being tested in trial NCT00268242?
The interventions under investigation include: Gemcitabine Hydrochloride (DRUG), Mitoxantrone Hydrochloride (DRUG).
Who is sponsoring clinical trial NCT00268242?
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 NCT00268242's enrollment target sits among peer trials
24 1756th of 2000 higher than 217 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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