Clinical trial · Interventional
Idarubicin Versus High Dose Daunorubicin in Acute Myelogenous Leukemia (AML)
A Prospective Randomized Comparison of Idarubicin and High-dose Daunorubicin in Combination With Cytarabine in the Induction Chemotherapy for Acute Myeloid Leukemia
NCT01145846CI-TRIAL-00003575AIvsADunknownPhase 3ClinicalTrials.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 non-inferiority study is to compare the effectiveness of two induction chemotherapy regimens (cytarabine plus idarubicin \[AI\] versus cytarabine plus high-dose daunorubicin \[AD\]) in AML. The effectiveness will be evaluated in terms of complete remission (CR) rate.
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 |
|---|---|---|---|
| Acute Myelogenous Leukemia | Acute Myeloid Leukemia | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cytarabine plus Daunorubicin [Arm II (AD regimen)] | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm I (AI regimen)
- description
- Cytarabine 200 mg/m2/day by continuous iv infusion over 24 hours daily for 7 days (D 1-7) plus Idarubicin 12 mg/m2/day iv daily for 3 days (D 1-3)
- interventionNames
- Drug: Cytarabine plus Daunorubicin [Arm II (AD regimen)]
Primary outcomes (1)
- measure
- Complete remission rate
- timeFrame
- five years
- description
- A complete remission will be defined as blasts of 5% or less in a normocellular bone marrow with neutrophils of 1,000/mcL or more and platelets of 100,000/mcL or more in the peripheral blood, the disappearance of all blasts in the peripheral blood, and no evidence of extramedullary leukemic cell infiltration
Secondary outcomes (1)
- measure
- Duration of CR, relapse-free survival(RFS),event-free survival(EFS),Overall survival(OS)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 15 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with previously-untreated acute myeloid leukemia (20% or more of blasts in bone marrow and/or blood; M6 subtype may have less than 20% of blasts.). Therapy-related leukemia or leukemia after myelodysplastic syndrome will be included. * 15 years old or older, but 65 years or younger * Adequate performance status (Karnofsky score of 50 or more) * Adequate hepatic and renal function (AST, ALT, bilirubin and creatinine \< 2.5 x upper normal limit). Elevation of AST or ALT due to hepatic infiltration of leukemic cells will be permitted. * Adequate cardiac function (left ventricular ejection fraction of 45% or more on heart scan or echocardiogram) * Signed and dated informed consent must be obtained Exclusion Criteria: * Patients with acute promyelocytic leukemia or bcr-abl gene rearrangement * Patients with CNS leukemia * Patients with primary granulocytic sarcoma without bone marrow involvement * Prior chemotherapy for leukemia or anthracycline treatment for any malignancy. Hydroxyurea for reduction of leukemic cell burden before induction chemotherapy will be permitted. * Presence of significant active infection * Presence of uncontrolled bleeding * Significant cardiovascular disease including myocardial infarction within previous 6 months * Any coexisting major illness or organ failure * Patients with psychiatric disorder or mental deficiency severe as to make compliance with the treatment unlike, and making informed consent impossible * Nursing women, pregnant women, women of childbearing potential who do not want adequate contraception * Patients with a diagnosis of prior malignancy unless disease-free for at least 5 years following therapy with curative intent (except curatively treated nonmelanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia)
References
Publications (0)
Data not yet available
No reference posted for this study.