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NCT01729845 · ClinicalTrials.gov registry record · Phase 1
Decitabine Followed by Mitoxantrone Hydrochloride, Etoposide, and Cytarabine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndromes
A Phase 1 study, sponsored by Fred Hutchinson Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 52
- Enrollment target
NCT01729845: Completed Phase 1 study, sponsored by Fred Hutchinson Cancer Center.
NCT01729845 is a Phase 1 study that has completed, run by Fred Hutchinson Cancer Center. The registered enrollment target is 52 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (13% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01729845, a Phase 1 study, has completed, sponsored by Fred Hutchinson Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 52 participants
- Enrollment target
Study Summary
This phase I/II trial studies the side effects and best dose of decitabine followed by mitoxantrone hydrochloride, etoposide, and cytarabine and to see how well they work in treating patients with acute myeloid leukemia or high-risk myelodysplastic syndrome that has returned after a period of improvement or does not respond to treatment. Drugs used in chemotherapy, such as mitoxantrone hydrochloride, etoposide, cytarabine, and decitabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) may kill more cancer cells.
Primary Outcome
MTD (most tolerated dose) of decitabine, measured in number of dose limiting toxicities. MTD defined as the highest dose in which the incidence of dose limiting toxicity is \< 33%, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (Phase I)
Interventions
- DRUG Decitabine
- OTHER Laboratory Biomarker Analysis
- DRUG Etoposide
- DRUG Cytarabine
- DRUG Mitoxantrone Hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2012-12-20 |
| Est. Completion | 2017-04-03 |
| Phase | Phase 1 |
What the finished NCT01729845 record still lists
NCT01729845 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (13% lower).
The record links to 0 conditions, and to 5 interventions - of which Decitabine is the first listed.
NCT01729845 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01729845 about?
NCT01729845 is a clinical study titled "Decitabine Followed by Mitoxantrone Hydrochloride, Etoposide, and Cytarabine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndromes". This phase I/II trial studies the side effects and best dose of decitabine followed by mitoxantrone hydrochloride, etoposide, and cytarabine and to see how well they work in treating patients with acute myeloid leukemia or high-risk myelodysplastic syndrome that has returned after a period of improv...
What is the current status of trial NCT01729845?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 52 participants. The study started on 2012-12-20. Estimated completion is 2017-04-03.
What interventions are being tested in trial NCT01729845?
The interventions under investigation include: Decitabine (DRUG), Laboratory Biomarker Analysis (OTHER), Etoposide (DRUG), Cytarabine (DRUG), Mitoxantrone Hydrochloride (DRUG).
Who is sponsoring clinical trial NCT01729845?
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 NCT01729845's enrollment target sits among peer trials
52 956th of 2000 higher than 1,032 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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