Biologic Characterization of Patients With ITP

Not Applicable

Recruiting

• Conditions: Immune Thrombocytopenia

• Registration Number: NCT05694325
• Lead Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto

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.

Study Timeline

• Study First Submitted: 2023-01-12
• Study First Submitted QC: 2023-01-12
• Study First Posted: 2023-01-23
• Study Start: 2023-11-27
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-20
• Last Update Posted: 2024-05-21
• Primary Completion: 2026-11
• Study Completion: 2026-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
B-cell mediated disease incidence	at baseline	evaluation of percentage of patients with a predominant B-cell mediated disease

Trial Locations

Locations (5)

UOC ematologia AOU di Bologna; 🇮🇹 Bologna, Italy

Ematologia e centro trapianti ASL Piacenza; 🇮🇹 Piacenza, Italy

Ematologia Policlinico Universitario A.Gemelli; 🇮🇹 Roma, Italy

Sc Ematologia Ospedale S.G. Battista Molinette - Università Degli Studi Di Torino; 🇮🇹 Torino, Italy

SC Ematologia ASUGI; 🇮🇹 Trieste, Italy