Decoding the Inflammasome Influence on Treatment Response in Acute Myeloid Leukemia
ConditionAcute Myeloid Leukemia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCiceri Fabio
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Any gender,
Adults (>18 years old),
New suspect diagnosis of acute myeloid leukemia (ELN2022 Criteria)
Capable of comprehend the study and the consent form,
Disqualifiers
Pediatric patients (<18 years old),
Patients unable or unwilling to sign the informed consent.
Trial 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).
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Clinical Practice
Other interventionAll 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.
Treatment groups
80 Participants
are divided into 1 treatment groupGroup A: acute myeloid leukemia (AML) patients treated in the clinical units1 intervention
Trial outcomes
Primary outcomes
1
Inflammasome Activity
The outcome variable is the inflammasome activation in AML blasts (PB e BM)
Time frame
At diagnosis, in case of treatment failure and at 6 months after first line chemotherapy initiationSecondary outcomes
1
Correlation Inflammasome and Therapy
To evaluate the correlation between inflammasome activity and response to chemotherapy in patients with AML
Time frame
At diagnosis, in case of treatment failure and at 6 months after first line chemotherapy initiationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Ciceri Fabio
Lead sponsor
IRCCS San Raffaele
Sponsor institution
Azienda Ospedaliera Bianchi-Melacrino-Morelli
Collaborator
Source ClinicalTrials.gov