Real World Evaluation of the Activity and Safety of Fostamatinib in Consecutive Adult Patients With ITP

April 28, 2025 updated by: Gruppo Italiano Malattie EMatologiche dell'Adulto

Real World Evaluation Among Italian Centers of the Activity and Safety of Fostamatinib in Consecutive Adult Patients With Immune Thrombocytopenia (ITP)

This is a retrospective and prospective multicenter observational study with the aim to evaluate the real-life use of Fostamatinib in adult patients with chronic ITP, refractory to other treatments.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a retrospective and prospective multicenter observational study with the aim to evaluate the real-life use of Fostamatinib in adult patients with chronic ITP, refractory to other treatments.

All patients who received at least one dose of Fostamatinib between October 1st, 2021 and April 1st, 2023 outside interventional clinical trials in Italy in the participating centers will be invited to participate in the study. Every patient will be observed for at least 6 months until October 1st, 2023.

Study Type

Observational

Enrollment (Actual)

95

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Alessandria, Italy
        • AON SS. ANTONIO E BIAGIO E C. ARRIGO - SS emostasi e trombosi
      • Ancona, Italy
        • SOD Clinica Ematologica AOU Ospedali Riuniti Umberto I GM Lancisi G Salesi
      • Bari, Italy
        • UO Ematologia con trapianto-Università degli Studi di Bari Aldo Moro
      • Bologna, Italy
        • Istituto di Ematologia "Lorenzo e A. Seragnoli" Policlinico S. Orsola
      • Brescia, Italy
        • Asst Degli Spedali Civili Di Brescia - Uo Ematologia
      • Catania, Italy
        • Unità di Onco-Ematologia - Azienda Ospedaliera Garibaldi
      • Firenze, Italy
        • Ematologia A.O.U. Careggi
      • Milano, Italy
        • Milano Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico UOC Oncoematologia
      • Napoli, Italy
        • Ematologia AOU Università degli Studi di Napoli "Federico II"
      • Novara, Italy
        • .C.D.U. Ematologia - Università del Piemonte Orientale Amedeo Avogadro
      • Palermo, Italy
        • Aou Policlinico P. Giaccone Uo Ematologia
      • Palermo, Italy
        • Casa Di Cura La Maddalena S.P.A. - Dipartimento Oncologico Di Iii Livello - Uo Oncoematologia E Tmo
      • Pisa, Italy
        • Aou Pisana - Uo Ematologia Universitaria
      • Reggio Emilia, Italy
        • S.C. di Ematologia, Arcispedale Santa Maria Nuova I.R.C.C.S.
      • Roma, Italy
        • Aou Policlinico Tor Vergata Uoc Trapianto Cellule Staminali
      • Roma, Italy
        • Fondazione P.U. Agostino Gemelli Irccs - Area Ematologica
      • Torino, Italy
        • Divisione di Ematologia "Città della Salute e della Scienza di Torino"
      • Tricase, Italy
        • Azienda Ospedaliera "Cardinale G. Panico", Ematologia e Centro Trapianti midollo osseo
      • Trieste, Italy
        • Clinica Ematologica-Azienda Sanitaria Universitaria Integrata di Trieste
      • Verona, Italy
        • Aou Integrata Di Verona, Policlinico G.B. Rossi - Uoc Ematologia
      • Vicenza, Italy
        • ULSS N.6 Ospedale S. Bortolo - Ematologia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All adult ITP patients, refractory to other treatment, who received at least one dose of Fostamatinib between October 1st, 2021 and April 1st, 2023 outside interventional clinical trials in Italy in the participating Centers will be invited to participate in the study.

Description

Inclusion Criteria:

  1. Patients with chronic ITP who are refractory to other treatments and who received Fostamatinib according to standard clinical practice between October 1st, 2021 and April 1st, 2023
  2. Age greater or equal to 18 years at the treatment start
  3. Signed written informed consent document (if feasible) according to ICH/EU/GCP and national local laws

Exclusion Criteria:

  1. Contraindications or hypersensitivity to Fostamatinib, its active substance or any of its excipients
  2. Patients participating in an interventional clinical trial at the time of enrollment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Study group
All patients being observed during the study duration.
Drug: Fostamatinib
Patients with Chronic ITP, refractory to other treatment who received at least one dose of Fostamatinib outside clinical trials in Italy will be enrolled and observed for at least 6 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of ITP patients who receive Fostamatinib
Time Frame: 6 months
effectiveness evaluation of fostamatinib
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gruppo Italiano Malattie EMatologiche dell'Adulto

Investigators

  • Principal Investigator: Francesco Zaja, Ematologia ASUGI Trieste

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 5, 2023

Primary Completion (Actual)

May 31, 2024

Study Completion (Actual)

May 31, 2024

Study Registration Dates

First Submitted

November 4, 2022

First Submitted That Met QC Criteria

November 4, 2022

First Posted (Actual)

November 14, 2022

Study Record Updates

Last Update Posted (Actual)

April 30, 2025

Last Update Submitted That Met QC Criteria

April 28, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ITP1122

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on ITP - Immune Thrombocytopenia

Clinical Trials on Fostamatinib

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Lebanon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe