Spots Global Cancer Trial Database for Exploring Disease Immunogenicity and the Immunological Effects of Hypomethylating Agents in Acute Myeloid Leukemia
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Trial Identification
Brief Title: Exploring Disease Immunogenicity and the Immunological Effects of Hypomethylating Agents in Acute Myeloid Leukemia
Official Title: Exploring Disease Immunogenicity and the Immunological Effects of Hypomethylating Agents in Acute Myeloid Leukemia
Study ID: NCT03789981
Conditions
Interventions
Study Description
Brief Summary: This is a multicenter, prospective, translational study, to evaluate the immunogenic profile of AML cases according to immune checkpoint molecule expression.
Detailed Description: This is a multicenter, prospective, translational study. Pharmacological treatments will not be object of the present study. Patients will follow the prescribed therapeutic indications according to regular clinical practice. Biological samples and clinical data will be collected at fixed timepoints. 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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
Contact Details
Name: Giovanni Martinelli
Affiliation: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)
Role: STUDY_CHAIR
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