Clinical trial · Observational
Observational Study on the Outcome of AML Patients Treated With New Drugs in Real-life (BoxTrial)
Observational GIMEMA Study on the Outcome of Acute Myeloid Leukemia (AML) Patients Treated With New Drugs in Real-life
NCT06513273CI-TRIAL-00093587BoxrecruitingClinicalTrials.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 multicenter, prospective and retrospective observational study aims to evaluate the use and efficacy of new drugs or their combinations in real-life in a population of adult AML patients.
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 |
| Acute Myeloid Leukemia, Adult | Adult Acute Myeloid Leukemia | ONTOLOGY_EXACT | 0.98 |
| AML, Adult | Adult Acute Myeloid Leukemia | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- New therapies efficacy in terms of Overall survival
- timeFrame
- at 24 months
- description
- evaluation of the efficacy of the new therapies or their combinations in the real-life for AML patients in terms of Overall Survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Aged 18 years or older 2. AML diagnosis according to the ELN guidelines, excluding M3 3. Signed Informed consent, if applicable 4. Treatment initiation with novel drugs in monotherapy or combination, in accordance with the AIFA authorizations, from the AIFA registration up to 31.12.2027 with particular attention to: * patients affected by FLT3-mutated AML treated with gilteritinib. * patients affected by IDH-mutated AML treated with IDH inhibitors. * patients affected by AML in maintenance therapy with oral azacytidine. * patients affected by AML treated with glasdegib. * patients affected by AML treated with gemtuzumab ozogamicin. * other novel drugs or combination for the treatment of AML approved during the study period. Exclusion Criteria: Patients included in interventional clinical trials.
References
Publications (0)
Data not yet available
No reference posted for this study.