Clinical trial · Interventional
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
NCT01518556CI-TRIAL-00087434IDAMLcompletedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia, Myeloid, Acute | Leukemia | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Idarubicin | Drug | Idarubicin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Idarubicin
- description
- Idarubicin dose intensification for remission induction in acute myeloid leukemia
- interventionNames
- Drug: Idarubicin
Primary outcomes (2)
- measure
- Maximum tolerated dose of idarubicin in the phase I study.
- timeFrame
- Within 2 months after induction therapy in the phase I study.
- description
- The study design is adopted from traditional 3+3 design for phase I cancer clinical trials. The first three patients are treated at a starting dose (level 1). If none of the three patients experiences a DLT(dose-limiting toxicity), another group of three patients will be treated at the next higher dose level. However, if one of the first three patients experiences a DLT, three more patients will be treated at the same dose level. The dose increment continues until at least two patients among a cohort of three to six patients experience DLTs.The maximum tolerated dose is defined as the dose level just below this toxic dose level.
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.