Status:
COMPLETED
Safety and Efficacy Study of Idarubicin Dose Intensification to Treat Acute Myeloid Leukemia
Lead Sponsor:
Konkuk University Medical Center
Collaborating Sponsors:
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Seoul National University Hospital
Conditions:
Leukemia, Myeloid, Acute
Eligibility:
All Genders
20-65 years
Phase:
PHASE1
PHASE2
Brief 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.
Detailed Description
Up to nowadays, a standard induction therapy for acute myeloid leukemia(AML) has consisted of cytarabine 100-200 mg per square meter of body surface area(BSA) per day continuous infusion for 7 days wi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2025
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT01518556
Start Date
July 1 2011
End Date
March 1 2025
Last Update
March 20 2025
Active Locations (1)
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1
Division of Hematology-Oncology, Konkuk University Medical Center
Seoul, South Korea, 143-729