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NCT01839240 · ClinicalTrials.gov registry record · Phase 1
Azacitidine, Cytarabine, and Mitoxantrone Hydrochloride in Treating Patients With High-Risk Acute Myeloid Leukemia
A Phase 1 study, sponsored by University of Chicago.
- Completed
- Registry status
- Phase 1
- Development phase
- 50
- Enrollment target
NCT01839240: Completed Phase 1 study, sponsored by University of Chicago.
NCT01839240 is a Phase 1 study that has completed, run by University of Chicago. The registered enrollment target is 50 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01839240, a Phase 1 study, has completed, sponsored by University of Chicago.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 50 participants
- Enrollment target
Study Summary
This phase I trial studies the side effects and best dose of azacitidine when given together with cytarabine and mitoxantrone hydrochloride in treating patients with high-risk acute myeloid leukemia. Drugs used in chemotherapy, such as azacitidine, cytarabine, and mitoxantrone hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Azacitidine may also help cytarabine and mitoxantrone hydrochloride work better by making the cancer cells more sensitive to the drugs
Primary Outcome
DLT defined as any grade 4 or greater non-hematologic toxicity (except transient \[less than 48 hours\] nausea/vomiting, transient \[less than 48 hours\] liver function test derangements) or a grade 3 non-hematological toxicity lasting more than 7 days. Persistent bone marrow aplasia (in the absence of bone marrow involvement with disease) lasting more than 56 days would also be regarded as a DLT.
Interventions
- OTHER laboratory biomarker analysis
- DRUG azacitidine
- DRUG cytarabine
- DRUG mitoxantrone hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2012-06-06 |
| Est. Completion | 2019-08-16 |
| Phase | Phase 1 |
What the finished NCT01839240 record still lists
NCT01839240 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% lower).
The record links to 0 conditions, and to 4 interventions - of which laboratory biomarker analysis is the first listed.
NCT01839240 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01839240 about?
NCT01839240 is a clinical study titled "Azacitidine, Cytarabine, and Mitoxantrone Hydrochloride in Treating Patients With High-Risk Acute Myeloid Leukemia". This phase I trial studies the side effects and best dose of azacitidine when given together with cytarabine and mitoxantrone hydrochloride in treating patients with high-risk acute myeloid leukemia. Drugs used in chemotherapy, such as azacitidine, cytarabine, and mitoxantrone hydrochloride, work in...
What is the current status of trial NCT01839240?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 50 participants. The study started on 2012-06-06. Estimated completion is 2019-08-16.
What interventions are being tested in trial NCT01839240?
The interventions under investigation include: laboratory biomarker analysis (OTHER), azacitidine (DRUG), cytarabine (DRUG), mitoxantrone hydrochloride (DRUG).
Who is sponsoring clinical trial NCT01839240?
This trial is sponsored by University of Chicago, which has 796 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01839240's enrollment target sits among peer trials
50 973rd of 2000 higher than 984 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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