Clinical trial · Interventional
Standard Idarubicin and Cytarabine for the Treatment of Acute Myeloid Leukemia (AML)
Prospective Evaluation of Standard Chemotherapy Regimen of Idarubicin and Cytarabine in Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)
- 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 goal of this clinical research study is to find out if standard chemotherapy given with idarubicin and Cytarabine (ara-C) can help to control AML. Objectives: To determine the complete response (CR) rate, event-free survival (EFS) and overall survival (OS) of patients with newly diagnosed acute myeloid leukemia (AML) receiving standard combination chemotherapy with Idarubicin and cytarabine.
Conditions
Conditions (3)
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 Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| AML | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cytarabine | Drug | Cytarabine | ALIAS |
| Idarubicin | Drug | Idarubicin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Idarubicin + Cytarabine
- description
- Idarubicin 12 mg/m2 IV over 1 hour daily x 3 (days 1-3). Cytarabine 1.5 g/m2 IV over 24 hours daily on day 1-4 (age \<60 years) or days 1-3 (age \> 60 years).
- interventionNames
- Drug: Cytarabine
- Drug: Idarubicin
Primary outcomes (1)
- measure
- Complete Response (CR) Rate
- timeFrame
- Up to 2 months
- description
- Complete Response (CR): Normalization of marrow (\< 5% blasts; \>10% cellularity) and of peripheral blood counts (no circulating blasts, neutrophil count \> 109/L, platelet count \> 100 x 109/L).
Secondary outcomes (2)
- measure
- Event-Free Survival (EFS)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 15 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Diagnosis of 1) AML (WHO classification definition of \>/= 20% blasts). Patients with M6 AML with less than 20% blasts are eligible. 2. Patients aged 15 to 75 years are eligible. Patients must be chemo-naïve, i.e. not have received any prior chemotherapy (except hydrea) for AML. They could have received transfusions, hematopoietic growth factors or vitamins. Temporary measures such as pheresis or hydrea (0.5 to 5g daily or more for up to 3 days) are allowed . 3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, 2, or 3 at screening. 4. Serum biochemical values with the following limits: - creatinine \</= 2.0 mg/dl - total bilirubin \</= 2.0 mg/dL, unless increase is due to hemolysis - transaminases (SG PT) \</= 3x upper limit of normal (ULN) 5. Ability to understand and provide signed informed consent. Exclusion Criteria: 1. Subjects with Acute Promyelocytic Leukemia (APL). 2. Presence of active systemic infection. 3. Any coexisting medical condition that in the judgment of the treating physician is likely to interfere with study procedures or results. 4. Nursing women, women of childbearing potential with positive urine pregnancy test, or women of childbearing potential who are not willing to maintain adequate contraception (such as birth control pills, intrauterine device (IUD), diaphragm, abstinence, or condoms by their partner) over the entire course of the study.
References
Publications (0)
Data not yet available