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

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

Sponsors

Lead Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto

Source Gruppo Italiano Malattie EMatologiche dell'Adulto
Brief 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.

Detailed 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.

Overall Status Unknown status
Start Date May 2014
Completion Date October 2018
Primary Completion Date October 2018
Study Type Observational
Primary Outcome
Measure Time Frame
Number of patients responding to TPO-mimetics Six months.
Secondary Outcome
Measure Time Frame
Number of patients on TPO-mimetics eltrombopag and romiplostim as bridge therapy before splenectomy. Six months.
Frequency and ways of administration. Six months
Number of hemorrhagic events. At thirty days from splenectomy.
Frequency of toxicity. Six months
Enrollment 40
Condition
Eligibility

Sampling Method: Non-Probability Sample

Criteria:

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Francesco Zaja, Pr. Study Chair Clinica Ematologica, DISM, Azienda Ospedaliera Universitaria S. M. Misericordia
Overall Contact

Last Name: Enrico Crea

Email: [email protected]

Location
Facility: Status: Contact: Investigator:
U.O.C di Ematologia P.O. "S.Giuseppe Moscati" | Aversa, Italy Recruiting Giuseppe Caparrotti Giuseppe Caparrotti Principal Investigator Daniela Esposito Sub-Investigator
UOC Ematologia Ospedale " Mons. Dimiccoli" | Barletta, Italy Recruiting Giuseppe Tarantini Giuseppe Tarantini Principal Investigator Caterina Buquicchio Sub-Investigator
Policlinico di Careggi | Firenze, Italy Recruiting Alberto Bosi Alberto Bosi Principal Investigator Valentina Carrai Sub-Investigator
ASL Le/1 P.O. Vito Fazzi - U.O. di Ematologia ed UTIE | Lecce, Italy Recruiting Nicola Di Renzo Nicola Di Renzo Principal Investigator Margherita Giannoccaro Sub-Investigator
Unità Operativa Complessa) - Medicina Generale - Sezione di Ematologia - Ospedale Versilia USL 12 Toscana | Lido di Camaiore, Italy Recruiting Paola Lambelet Paola Lambelet Principal Investigator Federico Simonetti Sub-Investigator
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico UOC Oncoematologia- Padiglione Marcora 2° piano | Milano, Italy Recruiting Wilma Barcellini Wilma Barcellini Principal Investigator
Ospedale Niguarda " Ca Granda" - SC Ematologia Blocco SUD, Ponti Est, Scala E, 4° piano | Milano, Italy Recruiting Silvia Cantoni Silvia Cantoni Principal Investigator
Unità Trapianto di Midollo Ist. Nazionale Tumori | Milano, Italy Recruiting Massimo Di Nicola Massimo Di Nicola Principal Investigator Michele Magni Sub-Investigator
Azienda Ospedaliera "S.Gerardo" | Monza, Italy Recruiting Monica Carpenedo Monica Carpenedo Principal Investigator Veronica Coccini Sub-Investigator
S.C.D.U. Ematologia - DIMECS e Dipartimento Oncologico - Università del Piemonte Orientale Amedeo Avogadro | Novara, Italy Not yet recruiting Gianluca Gaidano Gianluca Gaidano Principal Investigator Mariangela Greco Sub-Investigator
Università degli Studi "Sapienza" - Dip Biotecnologie Cellulari ed Ematologia - Divisione di Ematologia | Roma, Italy Recruiting Maria Gabriella Mazzucconi Maria Gabriella Mazzucconi Principal Investigator
A.O. Santa Maria - Terni S.C Oncoematologia | Terni, Italy Recruiting Anna Maria Liberati Anna Maria Liberati Principal Investigator Angelo Genna Sub-Investigator
Clinica Ematologica - Policlinico Universitario | Udine, Italy Recruiting Francesco Zaja Francesco Zaja Principal Investigator
Università degli Studi di Verona - A. O. - Istituti Ospitalieri di Verona- Div. di Ematologia - Policlinico G.B. Rossi | Verona, Italy Recruiting Dino Veneri Dino Veneri Principal Investigator Giovanni Pizzolo Sub-Investigator
Location Countries

Italy

Verification Date

August 2018

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Acronym ITP0614
Patient Data No
Study Design Info

Observational Model: Case-Only

Time Perspective: Retrospective

Source: ClinicalTrials.gov