NCT01518556CompletedPhase 1/2
Safety and Efficacy Study of Idarubicin Dose Intensification to Treat Acute Myeloid Leukemia
Phase I/II Clinical Study of Idarubicin Dose Intensification for Remission Induction Therapy in Acute Myeloid Leukemia Patients Age of 65 Years or Less
Source: ClinicalTrials.gov · Last updated 20 Mar 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 49 (actual)
- First submitted
- 21 Jan 2012
- Start date
- Jul 2011
- Primary completion date
- Mar 2025
- Lead sponsor
- Konkuk University Medical Center
- Diseases
- Acute myeloid leukemia
- NCT number
- NCT01518556
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 49
- From Jul 2011 to the primary completion date, Mar 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- recent chemotherapy within 4 weeks prior to this study treatment
- current or recent treatment with any other investigational medicinal product within 28 days prior to this study enrollment
Other illness
- 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
- 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
Other
- pregnant or breastfeeding
- acute promyelocytic leukemia
- unsuitable for this study, in the investigator's opinion
Who the study is looking for
- 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
Age in the registry: 20 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Division of Hematology-Oncology, Konkuk University Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.