Clinical trial NCT05694325: Biologic Characterization of Patients With ITP
Official title: Biologic Characterization of Patients With Immune Thrombocytopenia (ITP)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Immune Thrombocytopenia
Lead sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto
Sponsor class: OTHER
First posted: 2023-01-23
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This is a no-profit, multicenter, biological, non-pharmacologic study aimed to characterize from a biological point of view previously untreated primary ITP patients. To this end, peripheral blood, fecal and bone marrow samples will be collected at baseline and at 30 days and 180 days after treatment initiation - for each line of therapy - and the results of the biological analysis performed at each time point will then be compared.

Detailed description: This is a no-profit, multicenter, biological, non-pharmacologic study aimed to characterize from a biological point of view ITP patients. Patients with previously untreated primary ITP who need first-line therapy will be included in the study.

To this end, peripheral blood, fecal and bone marrow samples will be collected at baseline and at 30 days and 180 days after treatment initiation. The same assessments will be repeated in case of any potential new line of therapy.

The results of the biological analysis performed at each time point will then be compared, in order to seek changes related to the natural history of the disease, the therapy administered and the response achieved.

Eligibility criteria: Inclusion Criteria:

1. Patients with primary ITP, in need for first line treatment according to 2019 ITP consensus2.
2. Previously untreated patients. Patients who have already started first-line therapy because of life-threatening bleeding are admitted to the study if samples are collected within 24 hours of starting treatment. In such cases, as first-line treatment steroids and platelet transfusions would be preferable over high-dose IVIg. Treatment received before the collection of samples will be carefully documented.
3. Age ≥ 18 years
4. Signed written informed consent according to ICH/EU/GCP and national local laws.

Exclusion Criteria:

1. Secondary ITP. Patients with ANA positivity without a diagnosis of SLE are admitted to the study. As far as patients with ITP and antiphospholipid antibodies positivity, those with triple positivity (anti-beta2glicoprotein antibodies, anti-cardiolipin antibodies, lupus anticoagulans positivity) are excluded.

Primary outcomes:
measure: B-cell mediated disease incidence
timeFrame: at baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: UOC ematologia AOU di Bologna
city: Piacenza
country: Italy
facility: Ematologia e centro trapianti ASL Piacenza
city: Roma
country: Italy
facility: Ematologia Policlinico Universitario A.Gemelli
city: Torino
country: Italy
facility: Sc Ematologia Ospedale S.G. Battista Molinette - Università Degli Studi Di Torino
city: Trieste
country: Italy
facility: SC Ematologia ASUGI
Study officials:
affiliation: SC Ematologia ASUGI
name: Elisa Lucchini
role: PRINCIPAL_INVESTIGATOR
References: