Actively Recruiting
Molecular Characterization of Patients With Acute Myeloid Leukemia and the Impact of Clonal Evolution in the Response to Therapeutic Treatments
Led by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Updated on 2025-01-30
20
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying patients with acute myeloid leukemia (AML) who have mutations in the FLT3 gene. The goal is to analyze these patients using advanced molecular techniques to identify different groups of cancer cells present at the start and observe how these groups change during treatment. This study focuses on understanding how the genetic makeup of the leukemia evolves under therapy, which may help explain why some patients do not respond well to treatment. The study uses single-cell molecular characterization methods to closely monitor the presence of cancer cell clones and subclones before and during therapy. By tracking these changes, researchers aim to detect genetic alterations that might cause resistance to FLT3 inhibitor treatments. This approach may lead to the development of new molecular markers to identify patients who are likely to be resistant or refractory to this therapy early on. Participants will be monitored to evaluate their response to therapy over time, with researchers focusing on treatment refractoriness as a primary outcome measured at the end of a three-year enrollment period. The study involves collecting and analyzing molecular data to better understand changes in the leukemia cells during treatment. This observational study is led by IRCCS Azienda Ospedaliero-Universitaria di Bologna and does not involve experimental treatments but rather detailed patient monitoring and molecular analysis.
CONDITIONS
Brief Title
Molecular Characterization of Patients With Acute Myeloid Leukemia and the Impact of Clonal Evolution in the Response to Therapeutic Treatments
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosis of acute myeloid leukemia with a FLT3 mutation
You will not qualify if you...
- Patients who have responded to therapy
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.
Duration - At enrollment
Participants undergo molecular characterization to identify clones and subclones of their leukemia at onset.
1 visit (in-person)
Duration - Up to 3 years
Participants are followed over time to observe clonal evolution and response to therapeutic treatments.
Periodic visits depending on treatment and assessments
Trial Site Locations
Total: 1 location
1
IRCCS Azienda Ospedaliero-Universitaria di Bologna Policlinico di Sant'Orsola
Bologna, Italy, 40138
Actively Recruiting
Research Team
E
Emanuela Ottaviani, MD
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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