Understanding how inflammation affects treatment response in acute myeloid leukemia
Decoding the Inflammasome Influence on Treatment Response in Acute Myeloid Leukemia
This study looks at how inflammation affects the response to treatment in newly diagnosed acute myeloid leukemia patients to see if it can help improve their care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IRCCS San Raffaele Academic / other |
| Drugs / interventions | chemotherapy, gemtuzumab |
| Locations | 2 sites (Reggio Calabria, Calabria and 1 other locations) |
| Trial ID | NCT06535113 on ClinicalTrials.gov |
What this trial studies
This observational study collects biological samples from newly diagnosed acute myeloid leukemia (AML) patients to analyze their inflammasome profiles before and after first-line chemotherapy. The research aims to explore the relationship between inflammation and AML treatment response, focusing on how inflammasome activity may influence the disease's progression and patient outcomes. By examining samples of peripheral blood and bone marrow, the study seeks to uncover mechanisms that could lead to improved treatment strategies for AML patients.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old who have a new diagnosis of acute myeloid leukemia.
Not a fit: Patients under 18 years old or those unable to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better understanding and potentially improved treatment options for patients with acute myeloid leukemia.
How similar studies have performed: While the specific approach of analyzing inflammasome profiles in AML is novel, there is growing evidence linking inflammation to cancer treatment responses in other studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Any gender, * Adults (\>18 years old), * New suspect diagnosis of acute myeloid leukemia (ELN2022 Criteria) * Capable of comprehend the study and the consent form, * Willing to sign the informed consent for the study. For the retrospective population we will select: biological samples (BM Biopsies, BM Aspirates and PB) already banked upon research purpose informed consent and collected from the 01/06/2006 up to 01/06/2024 from adults patients with diagnosis of acute myeloid leukemia according to ELN2017 Criteria. Exclusion Criteria: * Pediatric patients (\<18 years old), * Patients unable or unwilling to sign the informed consent.
Where this trial is running
Reggio Calabria, Calabria and 1 other locations
- GOM Bianchi Melacrino Morelli — Reggio Calabria, Calabria, Italy (Recruiting)
- IRCCS Ospedale San Raffaele — Milan, Milan, Italy (Recruiting)
Study contacts
- Study coordinator: Sara Mastaglio, Haematologist MD
- Email: ciceri.clinicaltrials@hsr.it
- Phone: +39 0226433917
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.