Observational Study on the Outcome of AML Patients Treated With New Drugs in Real-life (BoxTrial)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Acute Myeloid Leukemia, AML, Adult, Acute Myeloid Leukemia, Adult. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Observational GIMEMA Study on the Outcome of Acute Myeloid Leukemia (AML) Patients Treated With New Drugs in Real-life
Overview
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.
Detailed description
This multicenter, prospective and retrospective observational study (model: case only) aims to evaluate the use and efficacy of new drugs or their combinations in real-life in a population of adult AML patients treated at Italian GIMEMA centers. No additional procedures or visits other than those required by normal clinical practice will be required. every patient will be followed for a minimum of 24 months.
Primary outcome measures
- New therapies efficacy in terms of Overall survival [Time frame: at 24 months]
Eligibility criteria
Inclusion criteria
- Aged 18 years or older
- AML diagnosis according to the ELN guidelines, excluding M3
- Signed Informed consent, if applicable
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Italy · 2 centers
- Ematologia Ente Ecclesiastico Casa Sollievo Della Sofferenza — San Giovanni Rotondo
- UOC Ematologia AOU di SASSARI — Sassari
Identifiers
NCT: NCT06513273 · AML2824