Clinical trial · Interventional
Arsenic Trioxide, Cytarabine, and Idarubicin in Treating Patients With Acute Myeloid Leukemia
Arsenic Trioxide, High-Dose Cytarabine and Idarubicin Induction Therapy in Previously Untreated de Novo and Secondary Adult Acute Myeloid Leukemia Patients < 60 Years Old - A Phase I Study
NCT00093483CI-TRIAL-00013428completedPhase 1ClinicalTrials.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)
RATIONALE: Drugs used in chemotherapy, such as arsenic trioxide, cytarabine, and idarubicin, work in different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. PURPOSE: This phase I trial is studying the side effects and best dose of arsenic trioxide when given together with cytarabine and idarubicin in treating patients with 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 | Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| arsenic trioxide | Drug | Arsenic Trioxide | ALIAS |
| cytarabine | Drug | Cytarabine | ALIAS |
| filgrastim | Biological | Filgrastim | ALIAS |
| idarubicin | Drug | Idarubicin | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Maximum tolerated dose and/or biologically effective dose or arsenic trioxide
- timeFrame
- 30 days after completion of study treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 59 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed de novo or secondary acute myeloid leukemia with ≥ 20% blasts AND at least 1 of the following characteristics\*: * Auer rods * Peroxidase or sudan black positive blasts * Chloroacetate esterase-positive or diffusely non-specific esterase-positive blasts * Presence of a myeloid immunophenotype by multiparameter flow cytometry, including expression of one or more myeloid markers (CD13, CD33) on blasts NOTE: \*Megakaryocytic leukemia can be diagnosed by the detection of platelet antigens (e.g. factor VIII, glycoprotein Ib or IIb/IIIa) using monoclonal antibodies or the presence of ultrastructural platelet peroxidase * No acute promyelocytic leukemia * No Philadelphia-chromosome positive chronic myeloid leukemia * Prior hematologic disorders, including myelodysplastic syndromes, aplastic anemia, paroxysmal nocturnal hemoglobinuria, and myeloproliferative disorders allowed PATIENT CHARACTERISTICS: Age * 18 to 59 Performance status * Not specified Life expectancy * More than 4 weeks Hematopoietic * Not specified Hepatic * Bilirubin ≤ 2 times normal\* * SGOT ≤ 2 times normal\* * Alkaline phosphatase ≤ 2 times normal\* NOTE: \*Unless abnormalities are directly attributable to leukemia Renal * Creatinine ≤ 1.5 times normal\* NOTE: \*Unless abnormalities are directly attributable to leukemia Cardiovascular * Cardiac ejection fraction ≥ 45%\* * Absolute QT interval ≤ 460 msec with potassium \> 4.0 mEq/L and magnesium \> 1.8 mg/dL * No myocardial infarction within the past 6 months * No uncontrolled symptomatic congestive heart failure * No angina pectoris * No multifocal cardiac arrythmias * No other severe cardiovascular disease NOTE: \*Unless abnormalities are directly attributable to leukemia Other * No serious medical or psychiatric illness that would preclude informed consent or limit survival to \< 4 weeks * No uncontrolled diabetes mellitus * No other concurrent active malignancy * No known hypersensitivity to E. coli-derived drug preparations * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 3 months after study participation PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * No prior chemotherapy for acute leukemia, except hydroxyurea to control white blood cell counts * Prior chemotherapy for an antecedent malignancy or other medical condition allowed Endocrine therapy * Not specified Radiotherapy * Prior radiotherapy for an antecedent malignancy or other medical condition allowed Surgery * Not specified
References
Publications (0)
Data not yet available
No reference posted for this study.