Cytarabine and Daunorubicin Hydrochloride in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia
Phase 1
Completed
NCT02971397
| Condition | Acute Myeloid Leukemia |
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| Phase | Phase 1 |
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| Sponsor | Wake Forest University Health Sciences |
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| Status | Completed |
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| Enrollment | 40 participants |
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| Interventions | Bone Marrow Aspiration and Biopsy, Cytarabine, Daunorubicin Hydrochloride, Laboratory Biomarker Analysis |
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| Start date | Nov, 2016 |
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| Completion date | Mar, 2018 |
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| Results posted | Mar 23, 2026 |
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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.
Number of Participants With Cardiac Toxicity, Defined as Reduction in LVEF of >= 10% Compared to Baseline LVEF and EF =< 50% on the Follow-up Scan, Assessed Using MRI
Baseline up to 3 months · Participants
| Treatment (Cytarabine, Daunorubicin Hydrochloride, Biopsy) | 3 Participants |
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Unexpected Toxicities (Exclude Hematologic and Infectious) ≥ Grade 3, as Measured by CTCAE v 4.0
Up to 30 days after last dose of study drug · events
| Treatment (Cytarabine, Daunorubicin Hydrochloride, Biopsy) | 3 events |
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| Treatment (Cytarabine, Daunorubicin Hydrochloride, Biopsy) | 2 events |
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| Treatment (Cytarabine, Daunorubicin Hydrochloride, Biopsy) | 3 events |
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| Treatment (Cytarabine, Daunorubicin Hydrochloride, Biopsy) | 1 events |
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| Treatment (Cytarabine, Daunorubicin Hydrochloride, Biopsy) | 2 events |
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| Treatment (Cytarabine, Daunorubicin Hydrochloride, Biopsy) | 2 events |
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Proportion of Patients Who Complete the Infusion Therapy
72 hours · Participants
| Treatment (Cytarabine, Daunorubicin Hydrochloride, Biopsy) | 40 Participants |
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Open in BENITIONS
View on ClinicalTrials.gov
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