Clinical trial NCT03789981: 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 type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Acute Myeloid Leukemia
Keywords: AML
Acute Myeloid Leukemia
Immunogenic profile
transcriptome analysis
Lead sponsor: Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
Sponsor class: OTHER
First posted: 2018-12-31
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: AML patients affected by primary or secondary AML, at diagnosis or relapse

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 criteria: Inclusion Criteria:

1. 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:
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:

1. Age \< 18 years
2. AML M3 subtype according to FAB classification

Primary outcomes:
measure: Evaluation of the Immunogenic profile of primary or secondary AML patients in according to the variations in expression of molecules involved in immune checkpoint
timeFrame: up to 30 months
Secondary outcomes:
measure: Investigation of the relationship between leukemia immunogenicity and immune checkpoint activation
timeFrame: up to 30 months
measure: Investigation of the activation of immune checkpoint molecules
timeFrame: up to 30 months
measure: The investigation of the association of the immune checkpoint status with clinical outcomes
timeFrame: up to 30 months
measure: The investigation of the association of the immunogenic profile with clinical outcomes
timeFrame: up to 30 months
Other outcomes:
Locations:
city: Brescia
country: Italy
facility: AO Spedali Civili di Brescia
state: BS
city: Meldola
country: Italy
facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)
state: FC
city: San Giovanni Rotondo
country: Italy
facility: IRCCS Casa sollievo sofferenza
state: Foggia
city: Genova
country: Italy
facility: IRCCS AOU S. Martino Genova
state: GE
city: Piacenza
country: Italy
facility: Ospedale G. Da Saliceto
state: PC
city: Rionero in Vulture
country: Italy
facility: Irccs Crob
state: PZ
city: Ravenna
country: Italy
facility: Osp. S. Maria delle Croci
state: RA
city: Rimini
country: Italy
facility: Ospedale degli Infermi
state: RN
city: Siena
country: Italy
facility: AOU Senese
state: SI
city: Orbassano
country: Italy
facility: Università di Torino
state: TO
city: Torino
country: Italy
facility: AO Ordine Mauriziano di Torino
state: TO
city: Treviso
country: Italy
facility: Azienda ULSS2 Marca Trevigiana
state: TV
city: Novara
country: Italy
facility: AOU Maggiore della Carità
city: Udine
country: Italy
facility: AOU di Udine
Study officials:
affiliation: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)
name: Giovanni Martinelli
role: STUDY_CHAIR
References: