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Clinical Trials in Italy / NCT06513273
Recruiting Observational

Observational Study on the Outcome of AML Patients Treated With New Drugs in Real-life (BoxTrial)

NCT06513273 · tracked via the Priya Life Science Italy tracker
Sponsor
Gruppo Italiano Malattie EMatologiche dell'Adulto
Phase
Observational
Started
2025-07-11
Last updated
2025-08-13

Condition(s) studied

Acute Myeloid LeukemiaAML, AdultAcute Myeloid Leukemia, Adult

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • New therapies efficacy in terms of Overall survival — at 24 months
    evaluation of the efficacy of the new therapies or their combinations in the real-life for AML patients in terms of Overall Survival

Trial sites (2)

FacilityCityRegionStatus
Ematologia Ente Ecclesiastico Casa Sollievo Della Sofferenza San Giovanni Rotondo Italy Recruiting
UOC Ematologia AOU di SASSARI Sassari Italy Recruiting

More Gruppo Italiano Malattie EMatologiche dell'Adulto trials in Italy

Novel Approaches to Target MECOM/EVI1 in AML Recruiting
Gemtuzumab Chemotherapy MRD Levels; Adult Untreated, de Novo, Fav Interm Risk AML Recruiting
Front-line VenObi Combination Followed by Ven or VenZan Combination in Patients With Residual Disease: a MRD Tailored Treatment for Young Patients With High-risk CLL Active, not recruiting
Trial in AML Secondary to MPNs Patients, Unfit for Intensive Chemotherapy, Investigating a Treatment Combination Including Decitabine and Venetoclax Active, not recruiting
Molecular Mechanisms of Disease Relapse After Allogenic Stem Cell Transplantation in MDS Patients Recruiting

Other trials for the same condition

Novel Approaches to Target MECOM/EVI1 in AML Recruiting
Gemtuzumab Chemotherapy MRD Levels; Adult Untreated, de Novo, Fav Interm Risk AML Recruiting
Venetoclax and Decitabine Assessment in Patients (≥60 - <75 Years) with Newly Diagnosed AML Eligible for Allo-SCT Active, not recruiting
A Multi-phase Study of ASTX030 (Azacitidine and Cedazuridine) in Myeloid Neoplasm Alone or in Combination With Venetoclax in AML (AZTOUND Study) Recruiting
Trial in AML Secondary to MPNs Patients, Unfit for Intensive Chemotherapy, Investigating a Treatment Combination Including Decitabine and Venetoclax Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06513273 on ClinicalTrials.gov ↗ ← All trials in Italy