Clinical trial · Interventional
Comparing the Consolidation Regimens of IDA With Intermediate-dose Cytarabine Versus Intermediate-dose Cytarabine Alone for Elderly AML Patients
Randomized Comparison of Consolidation Treatment in Elderly Patients With Acute Myeloid Leukemia: Idarubicin (IDA) Combined With Intermediate-dose Cytarabine Versus Intermediate-dose Cytarabine Alone
NCT04216771CI-TRIAL-00042586unknownPhase 2 / Phase 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)
This study evaluates Idarubicin (IDA) in combination with the intermediate-dose cytarabine, compared with intermediate-dose cytarabine alone, as a consolidation treatment for elderly AML in first remission.
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 |
|---|---|---|---|
| AML in Remission | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Idarubicin | Drug | Idarubicin | ALIAS |
| ID cytarabine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- IDA with ID Cytarabine
- interventionNames
- Drug: Idarubicin
- Drug: ID cytarabine
- type
- ACTIVE_COMPARATOR
- label
- ID Cytarabine
- interventionNames
- Drug: ID cytarabine
Primary outcomes (1)
- measure
- Relapse free survival
- timeFrame
- 2 years
- description
- RFS
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 60 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Newly diagnosed de novo AML who achieved complete remission (CR), including CRi and CRp after a maximum number of 2 cycles of induction chemotherapy. * Histologically or morphologically confirmed diagnosis of AML except for AML M3 (acute promyelocytic leukemia) * No contraindication to anthracyclines : decompensated or uncontrolled heart failure, recent myocardial infarction, current signs of cardiac impairment, uncontrolled arrhythmias, LVEF (left ventricular ejection fraction) \< 50% * Age ≥ 60 years and \< 75 years * ECOG performance status ≤2 * Written informed consent * No psychological, familial, social, or geographic reason that would compromise clinical follow up Exclusion Criteria: * Relapsed or refractory AML * Patients with acute promyelocytic leukemia (APL) * Patients with secondary type AML (post myelodysplastic syndrome MDS or therapy-related AML) * Severe pshyciatric or organic disorder, supposed to be independent from AML, that would contraindicate treatment * Subjects for which allogeneic HSCT is planned in CR1 * Known allergic or hypersensitivity to idarubicin or cytarabine or to any of the test compounds, materials * Concurrent, uncontrolled medical condition, laboratory abnormality, or psychiatric illness which could place the subject at unacceptable risk * A co-morbid condition which, in the view of the Investigators, renders the subject at high risk from treatment complications
References
Publications (0)
Data not yet available
No reference posted for this study.