Safety and Efficacy Study of Idarubicin Dose Intensification to Treat Acute Myeloid Leukemia

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether idarubicin dose intensification is safe and effective as a remission induction therapy for acute myeloid leukemia.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Konkuk University Medical Center
• Collaborators: Chonbuk National University Hospital; Chung-Ang University Hosptial, Chung-Ang University College of Medicine; Ewha Womans University; Hanyang University Seoul Hospital; Pusan National University Hospital; Samsung Medical Center; Seoul National University Hospital; Soon Chun Hyang University
• Treatments: Idarubicin

Criteria

Inclusion Criteria:

• Patient has been fully informed, has complete understanding fo this study, and has given voluntary written informed consent to comply with the protocol requirements.

• previously untreated de novo or secondary acute myeloid leukemia, including biphenotypic leukemia

• age between 20 and 65 years

• adequate organ functions, unless these abnormalities are attributable to leukemia

• left ventricular ejection fraction > 45%

• serum creatinine < 1.5 x upper limit of normal

• total bilirubin < 1.5 x upper limit of normal

• alanine transferase and aspartate transferase < 2.5 x upper limit of normal if liver function abnormality is attributable to underlying leukemia, ALT and AST < 5 x upper limit of normal

• Eastern Cooperative Oncology Group performance status score of 0 to 2

Exclusion Criteria:

• hypersensitivity to the study drug

• any other malignancies within 3 years, except for cured non-melanoma skin cancer and curatively treated in situ carcinoma of the cervix

• New York Heart Association class III or IV heart failure, severe uncontrolled cardiac disease or myocardial infarction within the previous 6 months prior to the date of consent

• incapable of giving voluntary written informed consent to comply with the protocol requirements, which results from drug or alcohol intoxication, or neurological or psychiatric disorders

• pregnant or breastfeeding

• recent chemotherapy within 4 weeks prior to this study treatment

• acute promyelocytic leukemia

• current or recent treatment with any other investigational medicinal product within 28 days prior to this study enrollment

• unsuitable for this study, in the investigator's opinion