BENITIONSClinical Trial Intelligence

Cytarabine and Daunorubicin Hydrochloride in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia

Phase 1 Completed NCT02971397

ConditionAcute Myeloid Leukemia
PhasePhase 1
SponsorWake Forest University Health Sciences
StatusCompleted
Enrollment40 participants
InterventionsBone Marrow Aspiration and Biopsy, Cytarabine, Daunorubicin Hydrochloride, Laboratory Biomarker Analysis
Start dateNov, 2016
Completion dateMar, 2018
Results postedMar 23, 2026

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

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
Treatment (Cytarabine, Daunorubicin Hydrochloride, Biopsy)2 events
Treatment (Cytarabine, Daunorubicin Hydrochloride, Biopsy)3 events
Treatment (Cytarabine, Daunorubicin Hydrochloride, Biopsy)1 events
Treatment (Cytarabine, Daunorubicin Hydrochloride, Biopsy)2 events
Treatment (Cytarabine, Daunorubicin Hydrochloride, Biopsy)2 events

Proportion of Patients Who Complete the Infusion Therapy

72 hours · Participants

Treatment (Cytarabine, Daunorubicin Hydrochloride, Biopsy)40 Participants

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