LeukemiaPhase 3IPTASNCT01642563
Italian Platelet Technology Assessment Study
A Phase 3 study testing Platelet transfusion in people with Leukemia and Lymphoma, run by Centro Nazionale Sangue at 9 sites in Italy.
Trial summary
Italian Platelet Technology Assessment Study (IPTAS) aims at comparing bleeding frequency and severity after transfusion of standard platelets versus platelets prepared with two commercial pathogen reduction technologies (PRT) and to perform a proteomic analysis of standard versus PRT platelets. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Platelet transfusion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 456 participants
- Where
- 9 sitesItaly
- Study dates
- Oct 2010to Mar 2015
- Phase
- Phase 3
- 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
Who may be able to join
- adults (> 18 years)
- a hematooncology diagnosis (includes patients newly diagnosed and previously diagnosed)
- expected to require 2 or more PLT transfusions in 4 weeks
- hospital admission (patients admitted to out-patient clinics will not be enrolled)
- chemotherapy, related and matched unrelated donor (MUD)transplant recipients
- recurrent auto-transplanted patients, requiring chemotherapy
- negative pregnancy test in female patients less than 60 years old
Who cannot join
- presence of HLA class I abs on admission with PRA >20%
- historical documented record of 2 or more 1 hour post-TX PLT corrected count increments <5,000 per microliter
- previously included in IPTAS
- diagnosis of a solid tumor
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Italy9 sites
Azienda Ospedaliera Universitaria San Martino
Genova
Fondazione Ca' Granda Ospedale Maggiore Policlinico
Milan
Azienda Ospedaliera Universitaria Federico II
Naples
Ospedale di Padova
Padova
Fondazione IRCCS Policlinico San Matteo
Pavia
Azienda Ospedaliera Policlinico Umberto I
Roma
Ospedale di Udine
Udine
Azienda Ospedaliera Verona
Verona
Proteomics Laboratory, Università della Tuscia
Viterbo
About this study
Official title: A Multi-center, Single-blind, Randomized, Parallel, Non Inferiority Study to Separately Investigate the Effect of Standard Platelets Versus Platelets Prepared With Two Commercial Procedures of Pathogen Reduction Technologies (PRT) on Bleeding Incidence and Severity in Thrombocytopenic Recipients
Italian Platelet Technology Assessment Study (IPTAS) aims at comparing bleeding frequency and severity after transfusion of standard platelets versus platelets prepared with two commercial pathogen reduction technologies (PRT) and to perform a proteomic analysis of standard versus PRT platelets. The two technologies will be analyzed separately.
Primary endpoint: incidence of bleeding of grade 2 or greater in recipients of PRT platelets versus incidence in recipients of control (standard) platelets.
Read more
Secondary endpoints: time to the first grade 2 or greater bleeding event after the first study transfusion; proportion of transfusions given to treat breakthrough bleeding; number of days with grade 2 or greater bleeding during the period of platelet transfusion support; number of platelet units transfused and total dose of platelets transfused per day of thrombocytopenic platelet support; proportion of patients with acute transfusion reactions; post-transfusion platelet count increments
Observational endpoints: frequency of human leukocyte antigen (HLA) alloimmunization, frequency of clinical refractoriness to platelet transfusion with demonstrated HLA alloimmunization, frequency of clinical refractoriness to platelet transfusion that is persistent during the period of platelet support in the absence of HLA or human platelet antigen (HPA) alloimmunization
Patients will be evaluated for 4 weeks after randomization.
Read the detailed description
When patient's platelet count, done in early morning every day, falls below 10000/microliter, physician in charge issues a platelet transfusion request to transfusion service. Transfusion service (which knows patient treatment arm) issues a PRT product or a standard product as indicated, typically within hours of request receipt; patient's physician identifies unit code and intended recipient's code and determines vital signs (pulse, blood pressure, body temp). Transfusion is started and completed in 30 min. Adverse reactions are monitored by ward personnel and once a day IPTAS local coordinator visits the ward, checks IPTAS patients' records, fills IPTAS forms, examines and interviews each enrolled patient and transfers filled forms to data coordinating center in Milan.
- Being tested
- Platelet transfusion
- Keywords
- Platelet transfusion, Leukemia, Transfusion transmissible infections, Chemotherapy, Allogeneic hemopoietic stem cell transplant
- Medical subject headings
- Leukemia, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet transfusionProcedure or surgery
Also called Intercept, Mirasol
One dose of pathogen reduced platelets
Platelet transfusionProcedure or surgery
One dose of standard platelets
| Study group | Role | What they receive |
|---|---|---|
| Pathogen reduced platelets | Experimental | Transfusion Receives: Procedure: Platelet transfusion |
| Standard platelets | Active comparator | Transfusion Receives: Procedure: Platelet transfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of bleeding of grade 2 or greater in recipients of PRT platelets versus incidence in recipients of control (standard) platelets
Measured: Within 4 weeks after randomization
Secondary outcomes (7)
Time to the first grade 2 or greater bleeding event after the first study transfusion
Measured: Within 4 weeks after randomization
Proportion of transfusions given to treat breakthrough bleeding
Measured: Within 4 weeks after randomization
Number of days with grade 2 or greater bleeding during the period of platelet transfusion support
Measured: Within 4 weeks after randomization
Number of platelet units transfused per day of thrombocytopenic platelet support
Measured: Within 4 weeks after randomization
Proportion of patients with acute transfusion reactions
Measured: Within 4 weeks after randomization
Post-transfusion platelet count increments
Measured: Within 4 weeks after randomization
Total dose of platelets transfused per day of thrombocytopenic platelet support
Measured: Within 4 weeks after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2012 (estimated)
- Study startOct 2010
- Primary completionOct 2014
- Study completionMar 2015
Why it stopped: Patient enrolment below planned schedule
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LeukemiaStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 456 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro Nazionale Sangue
- Sponsor type
- Other government
- Collaborators
- Cerus Corporation, Terumo BCT
- Responsible party
- Sponsor
- Investigators
- Paolo Rebulla, MD, Principal investigator, Fondazione Ca' Granda Ospedale Maggiore PoliclinicoStefania Frasca, Eng, Study director, Data ManagementLaura Angelici, MD, Study director, Fondazione Ca' Granda ospedale Maggiore Policlinico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01642563
- Sponsor's protocol ID
- ISS-2007646931
- Acronym
- IPTAS
- Status last verified
- Sep 2014
- First submitted
- 13 Jul 2012
- Last updated
- 28 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rebulla P, Grazzini G, Liumbruno GM, Aprili G, Formisano S, Girelli G, Marconi M, Salvaneschi L, Strada P, Zolla L. Pathogen inactivated platelets and prevention of immunological adverse reactions: the Italian Platelet Technology Assessment Study (IPTAS). Blood Transfus 2009;7 Suppl 1:s19-s21. DOI 10.2450/2009.0013-09.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Single-blind, Randomized, Parallel, Non Inferiority Study to Separately Investigate the Effect of Standard Platelets Versus Platelets Prepared With Two Commercial Procedures of Pathogen Reduction Technologies (PRT) on Bleeding Incidence and Severity in Thrombocytopenic Recipients
- ClinicalTrials.gov ID
- NCT01642563
- Acronym / sponsor ID
- IPTAS / ISS-2007646931
- Keywords
- Platelet transfusion, Leukemia, Transfusion transmissible infections, Chemotherapy, Allogeneic hemopoietic stem cell transplant
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Patient enrolment below planned schedule
- Enrolment
- 456 participants (actual)
- Lead sponsor
- Centro Nazionale SangueOther government
- Collaborators
- Cerus Corporation, Terumo BCT
- Study start
- Oct 2010
- Primary completion
- Oct 2014 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 17 Jul 2012 (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.
Italian Platelet Technology Assessment Study (IPTAS) aims at comparing bleeding frequency and severity after transfusion of standard platelets versus platelets prepared with two commercial pathogen reduction technologies (PRT) and to perform a proteomic analysis of standard versus PRT platelets. The two technologies will be analyzed separately.
Primary endpoint: incidence of bleeding of grade 2 or greater in recipients of PRT platelets versus incidence in recipients of control (standard) platelets.
Secondary endpoints: time to the first grade 2 or greater bleeding event after the first study transfusion; proportion of transfusions given to treat breakthrough bleeding; number of days with grade 2 or greater bleeding during the period of platelet transfusion support; number of platelet units transfused and total dose of platelets transfused per day of thrombocytopenic platelet support; proportion of patients with acute transfusion reactions; post-transfusion platelet count increments
Observational endpoints: frequency of human leukocyte antigen (HLA) alloimmunization, frequency of clinical refractoriness to platelet transfusion with demonstrated HLA alloimmunization, frequency of clinical refractoriness to platelet transfusion that is persistent during the period of platelet support in the absence of HLA or human platelet antigen (HPA) alloimmunization
Patients will be evaluated for 4 weeks after randomization.
Detailed description
When patient's platelet count, done in early morning every day, falls below 10000/microliter, physician in charge issues a platelet transfusion request to transfusion service. Transfusion service (which knows patient treatment arm) issues a PRT product or a standard product as indicated, typically within hours of request receipt; patient's physician identifies unit code and intended recipient's code and determines vital signs (pulse, blood pressure, body temp). Transfusion is started and completed in 30 min. Adverse reactions are monitored by ward personnel and once a day IPTAS local coordinator visits the ward, checks IPTAS patients' records, fills IPTAS forms, examines and interviews each enrolled patient and transfers filled forms to data coordinating center in Milan.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pathogen reduced platelets | Experimental | Procedure: Platelet transfusionTransfusion |
| Standard platelets | Active comparator | Procedure: Platelet transfusionTransfusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- adults (> 18 years)
- a hematooncology diagnosis (includes patients newly diagnosed and previously diagnosed)
- expected to require 2 or more PLT transfusions in 4 weeks
- hospital admission (patients admitted to out-patient clinics will not be enrolled)
- chemotherapy, related and matched unrelated donor (MUD)transplant recipients
Key exclusion criteria (4 listed)
- presence of HLA class I abs on admission with PRA >20%
- historical documented record of 2 or more 1 hour post-TX PLT corrected count increments <5,000 per microliter
- previously included in IPTAS
- diagnosis of a solid tumor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Platelet transfusionAlso: Intercept, MirasolOne dose of pathogen reduced platelets | Procedure or surgery | Pathogen reduced platelets |
| Platelet transfusionOne dose of standard platelets | Procedure or surgery | Standard platelets |
Primary outcome
Incidence of bleeding of grade 2 or greater in recipients of PRT platelets versus incidence in recipients of control (standard) platelets
Time frame: Within 4 weeks after randomization
7 secondary outcomes
Time to the first grade 2 or greater bleeding event after the first study transfusion
Time frame: Within 4 weeks after randomization
Proportion of transfusions given to treat breakthrough bleeding
Time frame: Within 4 weeks after randomization
Number of days with grade 2 or greater bleeding during the period of platelet transfusion support
Time frame: Within 4 weeks after randomization
Number of platelet units transfused per day of thrombocytopenic platelet support
Time frame: Within 4 weeks after randomization
Proportion of patients with acute transfusion reactions
Time frame: Within 4 weeks after randomization
Post-transfusion platelet count increments
Time frame: Within 4 weeks after randomization
Total dose of platelets transfused per day of thrombocytopenic platelet support
Time frame: Within 4 weeks after randomization
Results and safety
The study was stopped early (reason given: Patient enrolment below planned schedule). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2015.
- BackgroundRebulla P, Grazzini G, Liumbruno GM, Aprili G, Formisano S, Girelli G, Marconi M, Salvaneschi L, Strada P, Zolla L. Pathogen inactivated platelets and prevention of immunological adverse reactions: the Italian Platelet Technology Assessment Study (IPTAS). Blood Transfus 2009;7 Suppl 1:s19-s21. DOI 10.2450/2009.0013-09.
Related trials for Leukemia
RecruitingPhase 3
Pivotal Open-label Phase 3 Clinical Study of QTX-2101 in Adult Patients With Acute Promyelocytic Leukemia
Acute Promyelocytic Leukemia (APL), Acute Promyelocytic Leukaemia
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Active, not recruitingPhase 1/2
Study to Evaluate the Safety and Preliminary Efficacy of Ibrutinib and Pembrolizumab in Patients With Chronic Lymphocytic Leukemia (CLL) or Mantle Cell Lymphoma (MCL)
Chronic Lymphocytic Leukemia, Mantle Cell Lymphoma
RecruitingPhase 1
Anti-CRLF2-R/TSLPR Chimeric Antigen Receptor T Cells (TSLPR-CART) in Participants With Recurrent or Refractory CRLF2-R/TSLPR-Overexpressing B-Cell Acute Lymphoblastic Leukemia (B-ALL)
B-All, Acute Lymphoblastic Leukemia
Active, not recruiting
High-Intensity Parent Intervention Program in Improving Learning and School Functioning in Latino Children With Acute Leukemia or Lymphoblastic Lymphoma
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
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.
Paolo Rebulla, MD principal investigator
Fondazione Ca' Granda Ospedale Maggiore Policlinico
Stefania Frasca, Eng study director
Data Management
Laura Angelici, MD study director
Fondazione Ca' Granda ospedale Maggiore Policlinico
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Platelet transfusion in people with Leukemia and Lymphoma, run by Centro Nazionale Sangue at 9 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 7 inclusion and 4 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: stopped early, as of the sponsor's last update on 28 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Patient enrolment below planned schedule). Results are not available in the source record.
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?
Incidence of bleeding of grade 2 or greater in recipients of PRT platelets versus incidence in recipients of control (standard) platelets (time frame: Within 4 weeks after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01642563, which also lists 1 linked publication.
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 28 Jul 2015.