Clinical trial NCT05613296: Real World Evaluation of the Activity and Safety of Fostamatinib in Consecutive Adult Patients With ITP
Official title: Real World Evaluation Among Italian Centers of the Activity and Safety of Fostamatinib in Consecutive Adult Patients With Immune Thrombocytopenia (ITP)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ITP - Immune Thrombocytopenia
Chronic ITP
Refractory ITP
Lead sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto
Sponsor class: OTHER
First posted: 2022-11-14
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

Brief summary: 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.

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.

Eligibility criteria: 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.

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