Understanding how inflammation affects treatment response in acute myeloid leukemia
Official title: Decoding the Inflammasome Influence on Treatment Response in Acute Myeloid Leukemia
Run by IRCCS San Raffaele · NCT06535113 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | IRCCS San Raffaele Academic / other |
| Drugs / interventions | chemotherapy, gemtuzumab |
| Locations | 2 sites (Reggio Calabria, Calabria and 1 other locations) |
| Status | Recruiting |
| Started | February 22, 2025 |
| Main results expected | May 11, 2026 |
| Study ends | August 31, 2026 |
| Registry record updated | June 8, 2026 |
| Trial ID | NCT06535113 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults over 18 years old who have a new diagnosis of acute myeloid leukemia.
✕Probably not a fit
Patients under 18 years old or those unable to provide informed consent may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.