IRSTB082 - Exploring Disease Immunogenicity and the Immunological Effects of Hypomethylating Agents in Acute Myeloid Leukemia (Immune-AML).

Studio Clinico

Patologia: Neoplasie ematologiche

Osservazionale-Sperimentale: Osservazionale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: No

Fase di studio: Non applicabile

Linee di trattamento: Non applicabile

Criteri di inclusione: 

- Patients with new diagnosis of primary or secondary AML candidate to first line treatment with hypomethylating agents (specific for Cohort 1) Patients with primary or secondary AML who relapse after/during first line treatment with hypomethylating agents (specific for Cohort 2)

for each cohort:

- Participant is willing and able to give informed consent for participation in the study
- Male or Female, aged >18 years
- Availability of clinical data.

Criteri di esclusione: 

- Age < 18 years
- AML M3 subtype according to FAB classification.

Trattamento sperimentale: 

Immunogenic profile
RNA sequencing (RNAseq), Whole exome sequencing (WES), NeoAntigens (NeoAg), Immune checkpoints analysis, Gene expression profiling.

Trattamento di controllo: 

NA

Obiettivi primari dello studio: 

Evaluation of the Immunogenic profile of primary or secondary AML patients in according to the variations in expression of molecules involved in immune checkpoint [ Time Frame: up to 30 months ]
    The immunogenic profile of AML cases obtained by NeoAgprediction will be related with established biological and clinical parameters (including karyotype, percentage of blasts, clinical outcome) performing RNA sequencing (RNAseq) and whole exome sequencing (WES) analysis.

Obiettivi secondari dello studio: 

- Investigation of the relationship between leukemia immunogenicity and immune checkpoint activation [ Time Frame: up to 30 months ]
    the relationship between leukemia immunogenicity and immune checkpoint activation through transcriptome analysis of downstream pathways by flow cytometric analysis

- Investigation of the activation of immune checkpoint molecules [ Time Frame: up to 30 months ]
    Investigation of the activation of immune checkpoint molecules under the selective pressure of hypomethylating agents treatment by gene expression profilling

- The investigation of the association of the immune checkpoint status with clinical outcomes [ Time Frame: up to 30 months ]
    Investigation of the association of the immune checkpoint status with clinical outcomes (OS, PFS) estimated according to Kaplan-Meier.

- The investigation of the association of the immunogenic profile with clinical outcomes [ Time Frame: up to 30 months ]
    Investigation of the association of the immunogenic profile with clinical outcomes (OS, PFS) estimated according to Kaplan-Meier.

Centri partecipanti

Nord Italia

Centro Italia

Sud Italia e isole

Informazioni Generali

Protocollo

Numero di iscrizione a registro: NCT03789981

Data di inserimento: 20.09.2022

Promotore

Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

Principal Investigator ITALIA

Istituto Romagnolo per lo Studio dei Tumori 'Dino Amadori'- IRCCS

Riferimento: Prof. Giovanni Martinelli

Telefono: 0543739100

Email: giovanni.martinelli@irst.emr.it

Localita: Meldola (FC)