TPO-mimetics Before Splenectomy in Adult Primary Immune Thrombocytopenia Patients. (ITP0614)

October 12, 2020 updated by: Gruppo Italiano Malattie EMatologiche dell'Adulto

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

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

31

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
      • Aversa, Italy
        • U.O.C di Ematologia P.O. "S.Giuseppe Moscati"
      • Barletta, Italy
        • UOC Ematologia Ospedale " Mons. Dimiccoli"
      • Firenze, Italy
        • Policlinico di Careggi
      • Lecce, Italy
        • ASL Le/1 P.O. Vito Fazzi - U.O. di Ematologia ed UTIE
      • Lido di Camaiore, Italy
        • Unità Operativa Complessa) - Medicina Generale - Sezione di Ematologia - Ospedale Versilia USL 12 Toscana
      • Milano, 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
      • Monza, Italy
        • Azienda Ospedaliera "S.Gerardo"
      • Novara, Italy
        • S.C.D.U. Ematologia - DIMECS e Dipartimento Oncologico - Università del Piemonte Orientale Amedeo Avogadro
      • Roma, Italy
        • Università degli Studi "Sapienza" - Dip Biotecnologie Cellulari ed Ematologia - Divisione di Ematologia
      • Terni, Italy
        • A.O. Santa Maria - Terni S.C Oncoematologia
      • Udine, Italy
        • Clinica Ematologica - Policlinico Universitario
      • Verona, Italy
        • Università degli Studi di Verona - A. O. - Istituti Ospitalieri di Verona- Div. di Ematologia - Policlinico G.B. Rossi

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

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

ITP adult patients having undergone splenectomy after a bridge therapy with eltrombopag or romiplostim.

Description

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.

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: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients responding to TPO-mimetics
Time Frame: Six months.
According to platelet count and presence or absence of hemorrhagic events.
Six months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients on TPO-mimetics eltrombopag and romiplostim as bridge therapy before splenectomy.
Time Frame: Six months.
Six months.
Frequency and ways of administration.
Time Frame: Six months
Six months
Number of hemorrhagic events.
Time Frame: At thirty days from splenectomy.
Number and seriousness of hemorrhagic, thrombotic and infectious events at 30 days from splenectomy.
At thirty days from splenectomy.
Frequency of toxicity.
Time Frame: Six months
NCI CTCAE v. 4.0
Six 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

  • Study Chair: Francesco Zaja, Pr., Clinica Ematologica, DISM, Azienda Ospedaliera Universitaria S. M. Misericordia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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 14, 2014

Primary Completion (Actual)

February 26, 2015

Study Completion (Actual)

February 26, 2015

Study Registration Dates

First Submitted

February 13, 2014

First Submitted That Met QC Criteria

February 13, 2014

First Posted (Estimate)

February 14, 2014

Study Record Updates

Last Update Posted (Actual)

October 14, 2020

Last Update Submitted That Met QC Criteria

October 12, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ITP0614

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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.

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