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NCT02971397 · ClinicalTrials.gov registry record · Phase 1
Cytarabine and Daunorubicin Hydrochloride in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia
A Phase 1 study, sponsored by Wake Forest University Health Sciences.
- Completed
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
NCT02971397: Completed Phase 1 study, sponsored by Wake Forest University Health Sciences.
NCT02971397 is a Phase 1 study that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 40 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02971397, a Phase 1 study, has completed, sponsored by Wake Forest University Health Sciences.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
Study Summary
This pilot clinical trial studies the side effects of cytarabine and daunorubicin hydrochloride and to see how well they work in treating patients with newly diagnosed acute myeloid leukemia. Drugs used in chemotherapy, such as cytarabine and daunorubicin hydrochloride, 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, and may be safer for the heart.
Primary Outcome
Incidence of cardiac toxicity, defined as reduction in LVEF of \>= 10% compared to baseline LVEF and EF =\< 50% on the follow-up scan, assessed using MRI.
Interventions
- OTHER Laboratory Biomarker Analysis
- DRUG Cytarabine
- PROCEDURE Bone Marrow Aspiration and Biopsy
- DRUG Daunorubicin Hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2016-11 |
| Est. Completion | 2018-08-08 |
| Phase | Phase 1 |
What the finished NCT02971397 record still lists
NCT02971397 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower).
The record links to 0 conditions, and to 4 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT02971397 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02971397 about?
NCT02971397 is a clinical study titled "Cytarabine and Daunorubicin Hydrochloride in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia". This pilot clinical trial studies the side effects of cytarabine and daunorubicin hydrochloride and to see how well they work in treating patients with newly diagnosed acute myeloid leukemia. Drugs used in chemotherapy, such as cytarabine and daunorubicin hydrochloride, work in different ways to sto...
What is the current status of trial NCT02971397?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2016-11. Estimated completion is 2018-08-08.
What interventions are being tested in trial NCT02971397?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Cytarabine (DRUG), Bone Marrow Aspiration and Biopsy (PROCEDURE), Daunorubicin Hydrochloride (DRUG).
Who is sponsoring clinical trial NCT02971397?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02971397's enrollment target sits among peer trials
40 1130th of 2000 higher than 810 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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