LeukocytosisWBCDNCT02302365

Data Collection of Routine Clinical Use With the Spectra Optia® Apheresis System for White Blood Cell Depletion

An observational study of Leukocytosis, run by Terumo BCT at 3 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This study is a multicenter, retrospective data collection of routine clinical use with the Spectra Optia® apheresis system for white blood cell depletion. Read more about this study

Who is it for?: Any age
Conditions the study is for: Leukocytosis
What is being tested?: Spectra Optia® Apheresis System
Type of treatment: Medical device
How many people: 43 participants
Where: 3 sitesin 3 countries
Study dates: Apr 2014to Jul 2017
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: Patients who have undergone white blood cell depletion via the Spectra Optia Apheresis System which is likely to include patients with severe leukocytosis in acute leukemia (acute myeloid leukemia, acute lymphoblastic leukemia, or in chronic myelogenous leukemia) or to prevent tumor lysis syndrome.

Who may be able to join

Patients having received a minimum of 1 white blood cell depletion procedure via the Spectra Optia Apheresis System

Who cannot join

none

Trial locations and contacts

3 sites in 3 countries.

Country

City, postcode or hospital

3 sites in 3 countries

Belgium1 site

UZ Gasthuisberg
Leuven, 3000

Other trials in Belgium

Germany1 site

Institute for Transfusion Medicine and Immunohaematology, German Red Cross Blood Donor Service Baden-Württemberg-Hessen gGmbH, Johann-Wolfgang-Goethe-University Hospital
Frankfurt am Main, 60528

Other trials in Germany

Hungary1 site

Szent Istvan and Szent Laszlo Hospital of Budapest
Budapest, 1097

Other trials in Hungary

About this study

Official title: Multicenter, Retrospective Data Collection of Routine Clinical Use With the Spectra Optia® Apheresis System for White Blood Cell Depletion

This study is a multicenter, retrospective data collection of routine clinical use with the Spectra Optia® apheresis system for white blood cell depletion.

Read the detailed description

The goal of this study is to gather a broader knowledge and information from routine clinical use on the performance and safety of white blood cell depletion procedures with the Spectra Optia® apheresis system.

In order to do so, retrospective data on white blood cell depletion procedures with the Spectra Optia® apheresis system done in routine use in 3 different centers will be collected and analyzed.

Conditions: Leukocytosis
Being tested: Spectra Optia® Apheresis System
Keywords: white blood cell depletion, apheresis
Medical subject headings: Leukocytosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Spectra Optia® Apheresis SystemDevice
White Blood Cell Depletion

What is being measured

The primary outcome is the main question the study is designed to answer.

Percent Decrease in White Blood Cell Count in Patient Following Apheresis Procedure
Percent decrease in WBC count calculation: (WBCpre - WBCpost) / WBCpre x 100%
Measured: immediately after apheresis procedure: on average this will be within 15 minutes after the end of the procedure
Collection Efficiency (CE) for WBC (or Percent of Processed WBCs) Achieved by Spectra Optia.
Collection efficiency for WBC achieved by Spectra Optia System calculation: (WBC/µL depletion product x depletion product volume) / (WBCpre + WBCpost) / 2 x total processed blood volume)
Measured: immediately after apheresis procedure: on average this will be within 15 minutes after the end of the procedure
Adverse Events
Adverse events were defined as any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medical device, whether or not considered related to the medical device and/or procedure. Therefore, an AE could have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of the medical device and/or procedure.
Measured: Participants were followed for the duration of the procedure and for up to 24 hours after the procedure.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2014Jul 2017

First posted27 Nov 2014 (estimated)
Study startApr 2014
Primary completionJul 2017
Study completionJul 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for LeukocytosisStudies 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: 43 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02302365
Sponsor's protocol ID: CTS-5043
Acronym: WBCD
Status last verified: Jul 2018
First submitted: 18 Nov 2014
Last updated: 3 Jul 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 3 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Multicenter, Retrospective Data Collection of Routine Clinical Use With the Spectra Optia® Apheresis System for White Blood Cell Depletion
ClinicalTrials.gov ID: NCT02302365
Acronym / sponsor ID: WBCD / CTS-5043
Conditions: Leukocytosis
Keywords: white blood cell depletion, apheresis
Study type: Observational
Recruitment status: Completed
Enrolment: 43 participants (actual)
Lead sponsor: Terumo BCTIndustry (pharma, biotech, devices)
Study start: Apr 2014
Primary completion: Jul 2017 (actual)
Study completion: Jul 2017 (actual)
First posted: 27 Nov 2014 (estimated)
Results: Posted 3 Mar 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study is a multicenter, retrospective data collection of routine clinical use with the Spectra Optia® apheresis system for white blood cell depletion.

Detailed description

In order to do so, retrospective data on white blood cell depletion procedures with the Spectra Optia® apheresis system done in routine use in 3 different centers will be collected and analyzed.

Study design

Observational model: Case only
Time perspective: Retrospective

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Patients who have undergone white blood cell depletion via the Spectra Optia Apheresis System which is likely to include patients with severe leukocytosis in acute leukemia (acute myeloid leukemia, acute lymphoblastic leukemia, or in chronic myelogenous leukemia) or to prevent tumor lysis syndrome.

Key inclusion criteria (1 listed)

Patients having received a minimum of 1 white blood cell depletion procedure via the Spectra Optia Apheresis System

Key exclusion criteria (1 listed)

none

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
Spectra Optia® Apheresis SystemWhite Blood Cell Depletion	Device	–

Primary outcome

Percent Decrease in White Blood Cell Count in Patient Following Apheresis Procedure
Time frame: immediately after apheresis procedure: on average this will be within 15 minutes after the end of the procedure
Percent decrease in WBC count calculation: (WBCpre - WBCpost) / WBCpre x 100%
Collection Efficiency (CE) for WBC (or Percent of Processed WBCs) Achieved by Spectra Optia.
Time frame: immediately after apheresis procedure: on average this will be within 15 minutes after the end of the procedure
Collection efficiency for WBC achieved by Spectra Optia System calculation: (WBC/µL depletion product x depletion product volume) / (WBCpre + WBCpost) / 2 x total processed blood volume)
Adverse Events
Time frame: Participants were followed for the duration of the procedure and for up to 24 hours after the procedure.
Adverse events were defined as any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medical device, whether or not considered related to the medical device and/or procedure. Therefore, an AE could have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of the medical device and/or procedure.

Results and safety

Results posted to the registry on 3 Mar 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Subjects Who Received a Minimum of 1 WBCD Procedure	43	41

Primary outcome: Percent Decrease in White Blood Cell Count in Patient Following Apheresis Procedure

Time frame: immediately after apheresis procedure: on average this will be within 15 minutes after the end of the procedure. Mean (Standard Deviation). Unit: % change in subject's WBC count

Measure	WBCD Procedures Performed n = 43
Value	54.5 (21.40)

Population analysed: The Full Analysis Set comprised all 43 patients (58 procedures) for whom WBCD data were collected. One patient terminated the first procedure prematurely and therefore did not have post-procedure data, resulting in a total of 57 units analyzed.

Primary outcome: Collection Efficiency (CE) for WBC (or Percent of Processed WBCs) Achieved by Spectra Optia.

Time frame: immediately after apheresis procedure: on average this will be within 15 minutes after the end of the procedure. Mean (Standard Deviation). Unit: percent of processed WBCs

Measure	WBCD Procedures Performed n = 34
Value	58.7 (16.1)

Population analysed: The CE of the WBCD procedures was measured from the waste bag (depletion product) contents from Sites 2 and 3. WBC counts were not available from the waste bags for subjects treated at Site 1.

Primary outcome: Adverse Events

Time frame: Participants were followed for the duration of the procedure and for up to 24 hours after the procedure.. Number. Unit: Number of subjects with at least 1 TEAE

Measure	Safety Data Collection 0-2 Hours Post Apheresis Procedure n = 43	Safety Data Collection 0-24 Hours Post Apheresis Procedure n = 32
Value	37	30

Population analysed: Full and Safety Analysis Sets. 53.5% of subjects with acute myeloid leukemia (AML), 18.6% of subjects with chronic lymphocytic leukemia, \< 10% of subjects with other diagnoses. The WBCD procedure was performed most frequently to treat leukocytosis (44.2%), to prevent tumor lysis syndrome (34.9%), or to treat increased blood viscosity (20.9%).

Adverse events

Time frame: Adverse event data (including serious adverse events [SAEs]) were collected from the time of the start of the WBCD procedure through 2 hours post-procedure for 43 patients and 58 procedures. Adverse event data (including serious adverse events [SAEs]) were collected from the time of the start of the WBCD procedure through 24 hours post-procedure for 32 patients and 41 procedures.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
0-2 Hour Safety Data Collection	0 of 43 (0%)	37 of 43 (86%)	0 of 43
0-24 Hour Safety Data Collection	1 of 32 (3.1%)	30 of 32 (93.8%)	0 of 32

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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.

Isobelle Galeon, MD, MPH, MSCS study director

Medical Monitor, Clinical Safety

3 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Leukocytosis, run by Terumo BCT at 3 sites in 3 countries.

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 1 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 3 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Belgium, Germany, Hungary. 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?

Yes. Results are posted in the registry (first posted 3 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percent Decrease in White Blood Cell Count in Patient Following Apheresis Procedure (time frame: immediately after apheresis procedure: on average this will be within 15 minutes after the end of the procedure). The study lists 3 primary outcomes in all. 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 NCT02302365.

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 3 Jul 2018.