Clinical trial · Interventional
Optimal Treatment Strategy Based on for Pediatric AML
Optimal Treatment Strategy Based on Prognostic Groups for Pediatric de Novo Acute Myeloid Leukemia
NCT02848183CI-TRIAL-00023281unknownPhase 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 optimize therapy according to the known risk factors and treatment response in pediatric acute myeloid leukemia (AML)
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 |
|---|---|---|---|
| Pediatric Acute Myeloid Leukemia | Childhood Acute Myeloid Leukemia | ALIAS | 0.90 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cytarabine | Drug | Cytarabine | ALIAS |
| Etoposide | Drug | Etoposide | ALIAS |
| Hematopoietic stem cell transplantation | Procedure | — | UNRESOLVED |
| Idarubicin | Drug | Idarubicin | ALIAS |
| Mitoxantrone | Drug | Mitoxantrone | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Pediatric de novo acute myeloid leukemia
- description
- I. Chemotherapy Induction-1: Cytarabine + idarubicin Induction-2: High dose (HD) cytarabine + mitoxantrone Consolidation-1: Cytarabine + idarubicin Consolidation-2: HD cytarabine + etoposide Consolidation-3: HD cytarabine + mitoxantrone Consolidation-4: HD cytarabine + etoposide II. Allogeneic hematopoietic stem cell transplantation (HSCT) Favorable prognosis group: chemotherapy only Intermediate prognosis group: chemotherapy or HSCT with reduced intensity conditioning Poor prognosis group: HSCT with myeloablative conditioning
- interventionNames
- Drug: Cytarabine
- Drug: Idarubicin
- Drug: Mitoxantrone
- Drug: Etoposide
- Procedure: Hematopoietic stem cell transplantation
Primary outcomes (1)
- measure
- Rate of event free survival
- timeFrame
- Up to 5 years
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients who were newly diagnosed with de novo AML * Patients who had recurrent cytogenetic abnormalities of AML even though the bone marrow blast percent is lower than 20% Exclusion Criteria: * Acute promyelocytic leukemia * Down syndrome AML * Therapy-related AML * AML developed from myelodysplastic syndrome or other marrow failure syndrome * Isolated myeloid sarcoma without bone marrow involvement * Patients who cannot undergo chemotherapy as scheduled due to serious complications at diagnosis
References
Publications (0)
Data not yet available
No reference posted for this study.