ServiziMenu principale

<< Torna a "Tutti gli studi"

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

ASST Spedali Civili di Brescia
Piazzale Spedali Civili 1 - 25123 Brescia - BS
NB: Arruolamento pazienti non ancora attivo

 

IRCCS - IRST Meldola Dino Amadori
Via P. Maroncelli 40 - 47014 Meldola - FC

Riferimento: Prof. Giovanni Martinelli
Telefono: 0543739100
Email: giovanni.martinelli@irst.emr.it

 

IRCCS A.O.U. San Martino - IST
Largo Rosanna Benzi 10 - 16132 Genova - GE

 

A.O.U. Maggiore della Carità
Corso Mazzini 18 - 28100 Novara - NO

 

Ospedale di Piacenza
Via Taverna 49 - 29121 Piacenza - PC
Ospedale G. Da Saliceto

 

Ospedale S. Maria delle Croci, Ravenna
Viale Randi 5 - 48121 Ravenna - RA

 

Ospedale “Infermi” Rimini
Via Settembrini 2 - 47923 Rimini - RN

 

A.O.U San Luigi Gonzaga
Regione Gonzole 10 - 10043 Orbassano - TO
NB: Arruolamento pazienti non ancora attivo

 

AO - Ordine Mauriziano
Largo Turati 62 - 10128 Torino - TO
NB: Arruolamento pazienti non ancora attivo

 

Ospedale S. Maria di Ca’ Foncello
Piazzale Ospedale 1 - 31100 Treviso - TV
Azienda ULSS2 Marca Trevigiana

 

Azienda Ospedaliera Santa Maria della Misericordia
Piazzale Santa Maria della Misericordia 15 - 33100 Udine - UD

 

Centro Italia

Azienda Ospedaliera Universitaria Senese
Viale Bracci 16 - 53100 Siena - SI

 

Sud Italia e isole

IRCCS Ospedale Casa Sollievo della Sofferenza
Viale Cappuccini 1 - 71013 San Giovanni Rotondo - FG

 

IRCCS CROB
Via Padre Pio 1 - 85028 Rionero In Vulture - PZ

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)

 

<< Torna a "Tutti gli studi"