TPO-mimetics Before Splenectomy in Adult Primary Immune Thrombocytopenia Patients.

Adult Patients Clinical Trial

— ITP0614  

Official title:

Use of TPO-mimetics to Prepare for Splenectomy in Adult Patients With Primary Immune Thrombocytopenia. Brooklyn Observational Retrospective Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02063763
• Other study ID #: ITP0614
• Status: Completed
• Start date: May 14, 2014
• Est. completion date: February 26, 2015

Study information

• Verified date: October 2020
• Source: Gruppo Italiano Malattie EMatologiche dell'Adulto
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study aims at analyzing the therapeutic activity of TPO-mimetics Eltrombopag and Romiplostim as bridge therapy for splenectomy in adult patients with primary immune thrombocytopenia.

Description:

Adult immune primary thrombocytopenia is an autoimmune malignancy characterized by platelet destruction and inadequate platelet production. Its incidence is of three cases per 100,000 people a year, with a prevalence in women in young and older adults.

Splenectomy is, still today, the therapeutic approach that offers a bigger guarantee of a long term response (around 60+70%). Nevertheless, splenectomy may be accompanied by peri-operative complications in almost 10% of patients, which in rare cases may be fatal. These are normally hemorrhagic complications due to low platelet count. Thus, a previous therapy to increase platelets is advisable before any splenectomy.

In patients who are refractory to corticosteroids and immunoglobulins or when its use is not indicated, splenectomy has a potential risk of more complications. Since the last few years, we count with TPO-mimetic drugs, specific for c-MPL receptor, able to stimulate platelet production, such as romiplostim and eltrombopag.

Nowadays, TPO-mimetics are allowed in Italy when patients refuse splenectomy or when splenectomy is not contraindicated, but being ITP with a low platelet count (< 20-50.000/mmc) a potential contraindication to splenectomy due to hemorrhagic events, these drugs should be considered. Nevertheless, there are no data on therapeutic risks and safety of these agents when used for this indication. The aim of the present study is to verify, on an Italian national scale, the frequency of use, its impact and the safety profile.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: February 26, 2015
• Est. primary completion date: February 26, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Persistent or chronic ITP in symtomatic phase.

• 18 years of age or older.

• Indication for splenectomy due to refractory response to a previous therapy.

• Have used eltrombopag or romiplostim to increase platelet count before splenectomy.

• Have undergone splenectomy.

Exclusion Criteria:

• No informed consent.

Related Conditions & MeSH terms

• Adult Patients
• Immune Primary Thrombocytopenia
• Purpura, Thrombocytopenic, Idiopathic
• Splenectomy
• Thrombocytopenia
• TPO-mimetics

Locations

Country	Name	City	State
Italy	U.O.C di Ematologia P.O. "S.Giuseppe Moscati"	Aversa
Italy	UOC Ematologia Ospedale " Mons. Dimiccoli"	Barletta
Italy	Policlinico di Careggi	Firenze
Italy	ASL Le/1 P.O. Vito Fazzi - U.O. di Ematologia ed UTIE	Lecce
Italy	Unità Operativa Complessa) - Medicina Generale - Sezione di Ematologia - Ospedale Versilia USL 12 Toscana	Lido di Camaiore
Italy	Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico UOC Oncoematologia- Padiglione Marcora 2° piano	Milano
Italy	Ospedale Niguarda " Ca Granda" - SC Ematologia Blocco SUD, Ponti Est, Scala E, 4° piano	Milano
Italy	Unità Trapianto di Midollo Ist. Nazionale Tumori	Milano
Italy	Azienda Ospedaliera "S.Gerardo"	Monza
Italy	S.C.D.U. Ematologia - DIMECS e Dipartimento Oncologico - Università del Piemonte Orientale Amedeo Avogadro	Novara
Italy	Università degli Studi "Sapienza" - Dip Biotecnologie Cellulari ed Ematologia - Divisione di Ematologia	Roma
Italy	A.O. Santa Maria - Terni S.C Oncoematologia	Terni
Italy	Clinica Ematologica - Policlinico Universitario	Udine
Italy	Università degli Studi di Verona - A. O. - Istituti Ospitalieri di Verona- Div. di Ematologia - Policlinico G.B. Rossi	Verona

Sponsors (1)

Lead Sponsor	Collaborator
Gruppo Italiano Malattie EMatologiche dell'Adulto

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients responding to TPO-mimetics	According to platelet count and presence or absence of hemorrhagic events.	Six months.
Secondary	Number of patients on TPO-mimetics eltrombopag and romiplostim as bridge therapy before splenectomy.		Six months.
Secondary	Frequency and ways of administration.		Six months
Secondary	Number of hemorrhagic events.	Number and seriousness of hemorrhagic, thrombotic and infectious events at 30 days from splenectomy.	At thirty days from splenectomy.
Secondary	Frequency of toxicity.	NCI CTCAE v. 4.0	Six months

External Links

•   GIMEMA Foundation