Clinical trial · Interventional
A Risk-Oriented Therapeutic Strategy for Adult Acute Myelogenous Leukemia
Two-Step Remission Induction With Risk-Oriented Consolidation (High-Risk: Allogeneic Stem Cell Transplant; Standard-Risk: Multicycle High-Dose Cytarabine With Autologous Blood Stem Cell Support) for Adult Acute Myelogenous Leukemia
- 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 study was set up to assess: 1. A two-step, increasing-intensity remission induction phase. A conventional chemotherapy course (ICE, plus G-CSF) was followed, in unresponsive patients, by sequential high-dose cytarabine (plus G-CSF), aiming to provide an early effective rescue to as many refractory cases as possible. 2. A risk-oriented postremission consolidation phase. The objective was to adopt allogeneic stem cell transplantation (alloSCT) in high-risk (HR) cases, while standard-risk (SR) ones were consolidated with a multicycle high-dose cytarabine-containing program, which included the use of autologous stem cells plus G-CSF to limit drug-related toxicity and intercycle treatment delays.
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 |
|---|---|---|---|
| Two-step remission induction and risk-oriented consolidation | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Chemotherapy
- description
- Risk-oriented chemotherapy for remission induction (application of sequential high-dose cytarabine course to patients unresponsive to standard chemotherapy course 1) and postremission consiolidation(standard risk: blood stem cell supported high-dose cytarabine course \[x3\]; high risk: allogeneic SCT)
- interventionNames
- Behavioral: Two-step remission induction and risk-oriented consolidation
Primary outcomes (1)
- measure
- Disease-free survival
- timeFrame
- 5-years
- description
- Percent of patients who are disease-free 5 years from start of therapy
Secondary outcomes (4)
- measure
- Complete remission
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 15 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * age 15-65 years,untreated AML (de novo, secondary, myelodysplasia-related, granulocytic sarcoma),untreated high-risk myelodysplasia (RAEB, RAEB-T), informed consent Exclusion Criteria: * acute promyelocytic leukemia, comorbidity precluding intensive chemotherapy approaches
References
Publications (1)
- DERIVEDBorlenghi E, Cattaneo C, Bertoli D, Cerqui E, Archetti S, Passi A, Oberti M, Zollner T, Giupponi C, Pagani C, Bianchetti N, Bottelli C, Bagnasco S, Sciume M, Tucci A, Rossi G. Prognostic Relevance of NPM1 and FLT3 Mutations in Acute Myeloid Leukaemia, Longterm Follow-Up-A Single Center Experience. Cancers (Basel). 2022 Sep 28;14(19):4716. doi: 10.3390/cancers14194716. PMID 36230640