Exploring Disease Immunogenicity and the Immunological Effects of Hypomethylating Agents in Acute Myeloid Leukemia
NCT ID: NCT03789981
Last Updated: 2024-09-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
75 participants
OBSERVATIONAL
2019-07-19
2025-12-31
Brief Summary
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Detailed Description
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Aim of the study is to evaluate the immunogenic profile of AML cases according to immune checkpoint molecule expression.
A total of 75 AML patients affected by primary or secondary AML, at diagnosis ( 45 patients) or relapse (30 patients) will be enrolled in the protocol (18 months for patient enrolment). Blood,BM and saliva samples will be collected from each patients; for patients enrolled at diagnosis, samples will be collected before and after treatment with hypomethylating agents.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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At diagnosis
Immunogenic profile in patients affected by primary or secondary AML at diagnosis
Immunogenic profile
RNA sequencing (RNAseq), Whole exome sequencing (WES), NeoAntigens (NeoAg), Immune checkpoints analysis, Gene expression profiling
At relapse
Immunogenic profile in patients affected by primary or secondary AML at relapse
Immunogenic profile
RNA sequencing (RNAseq), Whole exome sequencing (WES), NeoAntigens (NeoAg), Immune checkpoints analysis, Gene expression profiling
Interventions
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Immunogenic profile
RNA sequencing (RNAseq), Whole exome sequencing (WES), NeoAntigens (NeoAg), Immune checkpoints analysis, Gene expression profiling
Eligibility Criteria
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Inclusion Criteria
for each cohort:
2. Participant is willing and able to give informed consent for participation in the study
3. Male or Female, aged \>18 years
4. Availability of clinical data
Exclusion Criteria
2. AML M3 subtype according to FAB classification
18 Years
ALL
No
Sponsors
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Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
OTHER
Responsible Party
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Principal Investigators
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Giovanni Martinelli
Role: STUDY_CHAIR
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)
Locations
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AO Spedali Civili di Brescia
Brescia, BS, Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)
Meldola, FC, Italy
IRCCS Casa sollievo sofferenza
San Giovanni Rotondo, FOGGIA, Italy
IRCCS AOU S. Martino Genova
Genova, GE, Italy
Ospedale G. Da Saliceto
Piacenza, PC, Italy
Irccs Crob
Rionero in Vulture, PZ, Italy
Osp. S. Maria delle Croci
Ravenna, RA, Italy
Ospedale degli Infermi
Rimini, RN, Italy
AOU Senese
Siena, SI, Italy
Università di Torino
Orbassano, TO, Italy
AO Ordine Mauriziano di Torino
Torino, TO, Italy
Azienda ULSS2 Marca Trevigiana
Treviso, TV, Italy
AOU Maggiore della Carità
Novara, , Italy
AOU di Udine
Udine, , Italy
Countries
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Other Identifiers
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IRSTB082
Identifier Type: -
Identifier Source: org_study_id
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