BENITIONSClinical Trial Intelligence

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

1상 완료 NCT02971397

대상 질환Acute Myeloid Leukemia
임상 단계1상
스폰서Wake Forest University Health Sciences
상태완료
참여자 수40 명
중재(약물)Bone Marrow Aspiration and Biopsy, Cytarabine, Daunorubicin Hydrochloride, Laboratory Biomarker Analysis
시작일2016년 11월
완료일2018년 3월
결과 공개일2026년 3월 23일

요약

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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