Actively Recruiting
Observational GIMEMA Study on the Outcome of Acute Myeloid Leukemia Patients Treated With New Drugs in Real-life
Led by Gruppo Italiano Malattie EMatologiche dell'Adulto · Updated on 2025-08-13
397
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a multicenter observational study to evaluate how new drugs or drug combinations are used and how effective they are in treating adult patients with Acute Myeloid Leukemia (AML). This study focuses on real-life treatment outcomes in patients treated at Italian GIMEMA centers, aiming to gain better understanding of novel therapies in everyday clinical practice. The study observes adult AML patients who start treatment with new drugs, either alone or in combination, as authorized by AIFA. Special attention is given to patients with specific genetic mutations such as FLT3 and IDH, treated with targeted drugs like gilteritinib and IDH inhibitors, as well as those on maintenance therapy with oral azacytidine or treated with glasdegib or gemtuzumab ozogamicin. No experimental treatments or additional visits beyond routine care are involved. Participants will be followed for at least 24 months using their regular clinical visits. Researchers will collect data on treatment use and measure outcomes such as overall survival at 24 months. The study does not require extra procedures beyond normal medical care, and participants' health will be monitored through standard clinical practice during this period.
CONDITIONS
Brief Title
Observational Study on the Outcome of AML Patients Treated With New Drugs in Real-life (BoxTrial)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 years or older
- Diagnosed with Acute Myeloid Leukemia according to ELN guidelines, excluding M3 subtype
- Signed informed consent, if applicable
- Treatment started with novel drugs or combinations approved by AIFA up to 31.12.2027, including gilteritinib for FLT3-mutated AML, IDH inhibitors for IDH-mutated AML, oral azacytidine maintenance therapy, glasdegib, gemtuzumab ozogamicin, or other approved new drugs for AML during the study period
You will not qualify if you...
- Participation in interventional clinical trials
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Minimum of 24 months
Participants who undergo routine care are observed to evaluate the use and efficacy of new drugs in real-life.
Visits as part of normal clinical practice
Trial Site Locations
Total: 2 locations
1
Ematologia Ente Ecclesiastico Casa Sollievo Della Sofferenza
San Giovanni Rotondo, Italy
Actively Recruiting
2
UOC Ematologia AOU di SASSARI
Sassari, Italy
Actively Recruiting
Research Team
P
Paola Fazi
E
Enrico Crea
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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