Decoding the Inflammasome Influence on Treatment Response in Acute Myeloid Leukemia

NCT06535113 | Recruiting

• 1 other identifier: PNRR-MCNT1-2023-12377456
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 2

Brief Summary

The study is designed as a collection of biological samples of newly diagnosed acute myeloid leukemia (AML) patients treated in the clinical units involved. Samples of peripheral blood (PB) and bone marrow (BM) will be analyzed to determine the Inflammasome profile before and after a first-line chemotherapy treatment.

Conditions

Acute Myeloid Leukemia

Keywords

Leukemia; Chemotherapy; inflammation; transplant

Outcome Measures

Primary Outcomes (1)

• Inflammasome Activity

  The outcome variable is the inflammasome activation in AML blasts (PB e BM)

  At diagnosis, in case of treatment failure and at 6 months after first line chemotherapy initiation

Secondary Outcomes (1)

• Correlation Inflammasome and Therapy

  At diagnosis, in case of treatment failure and at 6 months after first line chemotherapy initiation

Study Arms (1)

acute myeloid leukemia (AML) patients treated in the clinical units

acute myeloid leukemia (AML) patients treated in the clinical units

Other: Clinical Practice

Interventions

Clinical Practice OTHER

All the procedures in Study will be conducted as per Clinical practice for the pathology and all the samples will be collected according to ELN guidelines. There are no additional procedures but will be additionally collected up 20ml of peripheral blood and up to 15ml of Bone Marrow Aspirate at the same time of clinically indicated diagnostic procedures.

acute myeloid leukemia (AML) patients treated in the clinical units

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will be conducted on the population seen at the clinical centers as per common practice. The subjects eligible will be identified during the clinical practice diagnostic process for AML. The study will involve a total of 80 subjects based on the statistical design for the Study. The Coordinating Unit of the Study will include at least 55 subjects, the Other cooperating Centers will provide the remaining subjects. The retrospective samples will be identified through Biobanking Records in the pool of samples stocked and we estimate around 25% of the total population included (\~20 subjects).

You may qualify if:

• 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.

You may not qualify if:

• Pediatric patients (\<18 years old),
• Patients unable or unwilling to sign the informed consent.

Sponsors & Collaborators

• Ciceri Fabio: lead
• Azienda Ospedaliera Bianchi-Melacrino-Morelli: collaborator

Study Sites (2)

GOM Bianchi Melacrino Morelli

Reggio Calabria, Calabria, 89133, Italy

RECRUITING

IRCCS Ospedale San Raffaele

Milan, Milan, 20132, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

bone marrow, biopsies, and peripheral blood.

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Leukemia; Inflammation

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Sara Mastaglio, Haematologist MD

CONTACT

+39 0226433917; ciceri.clinicaltrials@hsr.it

Vincenzo Mercurio, Ph.D Trial Office Coordinator

CONTACT

+390226439396; regolatorio.scp@hsr.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. MD Director

Study Record Dates

• First Submitted: July 29, 2024
• First Posted: August 2, 2024
• Study Start: February 22, 2025
• Primary Completion: January 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: May 8, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)