Adult PatientsITP0614NCT02063763
TPO-mimetics Before Splenectomy in Adult Primary Immune Thrombocytopenia Patients.
An observational study of Adult Patients and Immune Primary Thrombocytopenia, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 14 sites in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adult Patients, Immune Primary Thrombocytopenia, Splenectomy
- How many people
- 31 participants
- Where
- 14 sitesItaly
- Study dates
- 14 May 2014to 26 Feb 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ITP adult patients having undergone splenectomy after a bridge therapy with eltrombopag or romiplostim.
Who may be able to join
- 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.
Who cannot join
- No informed consent.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Italy14 sites
U.O.C di Ematologia P.O. "S.Giuseppe Moscati"
Aversa
UOC Ematologia Ospedale " Mons. Dimiccoli"
Barletta
Policlinico di Careggi
Florence
ASL Le/1 P.O. Vito Fazzi - U.O. di Ematologia ed UTIE
Lecce
Unità Operativa Complessa) - Medicina Generale - Sezione di Ematologia - Ospedale Versilia USL 12 Toscana
Lido di Camaiore
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico UOC Oncoematologia- Padiglione Marcora 2° piano
Milan
Ospedale Niguarda " Ca Granda" - SC Ematologia Blocco SUD, Ponti Est, Scala E, 4° piano
Milan
Unità Trapianto di Midollo Ist. Nazionale Tumori
Milan
Azienda Ospedaliera "S.Gerardo"
Monza
S.C.D.U. Ematologia - DIMECS e Dipartimento Oncologico - Università del Piemonte Orientale Amedeo Avogadro
Novara
Università degli Studi "Sapienza" - Dip Biotecnologie Cellulari ed Ematologia - Divisione di Ematologia
Roma
A.O. Santa Maria - Terni S.C Oncoematologia
Terni
Clinica Ematologica - Policlinico Universitario
Udine
Università degli Studi di Verona - A. O. - Istituti Ospitalieri di Verona- Div. di Ematologia - Policlinico G.B. Rossi
Verona
About this study
Official title: 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.
Read the 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.
- Keywords
- Adult patients, Immune primary thrombocytopenia, Splenectomy, TPO-mimetics, Eltrombopag, Romiplostim
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients responding to TPO-mimetics
According to platelet count and presence or absence of hemorrhagic events.
Measured: Six months.
Secondary outcomes (4)
Number of patients on TPO-mimetics eltrombopag and romiplostim as bridge therapy before splenectomy.
Measured: Six months.
Frequency and ways of administration.
Measured: Six months
Number of hemorrhagic events.
Number and seriousness of hemorrhagic, thrombotic and infectious events at 30 days from splenectomy.
Measured: At thirty days from splenectomy.
Frequency of toxicity.
NCI CTCAE v. 4.0
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2014 (estimated)
- Study start14 May 2014
- Primary completion26 Feb 2015
- Study completion26 Feb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gruppo Italiano Malattie EMatologiche dell'Adulto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francesco Zaja, Pr., Study chair, Clinica Ematologica, DISM, Azienda Ospedaliera Universitaria S. M. Misericordia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02063763
- Sponsor's protocol ID
- ITP0614
- Acronym
- ITP0614
- Status last verified
- Oct 2020
- First submitted
- 13 Feb 2014
- Last updated
- 14 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of TPO-mimetics to Prepare for Splenectomy in Adult Patients With Primary Immune Thrombocytopenia. Brooklyn Observational Retrospective Study.
- ClinicalTrials.gov ID
- NCT02063763
- Acronym / sponsor ID
- ITP0614 / ITP0614
- Keywords
- Adult patients, Immune primary thrombocytopenia, Splenectomy, TPO-mimetics, Eltrombopag, Romiplostim
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Gruppo Italiano Malattie EMatologiche dell'AdultoUniversity, hospital or other
- Study start
- 14 May 2014 (actual)
- Primary completion
- 26 Feb 2015 (actual)
- Study completion
- 26 Feb 2015 (actual)
- First posted
- 14 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ITP adult patients having undergone splenectomy after a bridge therapy with eltrombopag or romiplostim.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- No informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of patients responding to TPO-mimetics
Time frame: Six months.
According to platelet count and presence or absence of hemorrhagic events.
4 secondary outcomes
Number of patients on TPO-mimetics eltrombopag and romiplostim as bridge therapy before splenectomy.
Time frame: Six months.
Frequency and ways of administration.
Time frame: Six months
Number of hemorrhagic events.
Time frame: At thirty days from splenectomy.
Frequency of toxicity.
Time frame: Six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2020.
- GIMEMA FoundationLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francesco Zaja, Pr. study chair
Clinica Ematologica, DISM, Azienda Ospedaliera Universitaria S. M. Misericordia
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adult Patients and Immune Primary Thrombocytopenia, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 14 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients responding to TPO-mimetics (time frame: Six months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2020.