Comparison of Two Automated Mononuclear Collection Systems in Patients Undergoing Extracorporeal Photochemotherapy. A Cross-over Equivalence Study. (MNC_CMNC)

Study Overview
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Brief Summary
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In a study performed in 2012, the investigators demonstrated that in ECP setting , the new automated device (Spectra Optia-MNC) released by Terumo BCT for MNCs collection based on intermittent flow is safe and ensures high-quality MNC collection and yield.(5, 6) More recently (in 2013), Terumo BCT released another automated system that allows to collect stem cells and MNCs basing on a continuous collection flow.(7, 8) The aim of this cross-over study is to compare yield (i.e. collection efficiency, CE) and quality (i.e. purity and contamination) of MNCs collected from patients undergoing ECP with two different automated systems: MNC and CMNC (Terumo BCT) processing 1.5 blood volumes during every collection procedure.

Detailed Description
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Two-sequences-in-four-periods cross-over, with the same patients randomized to both devices within each ECP cycle in two consecutive cycles, open-label. Cycle 1 Cycle 1 Cycle 2 Cycle 2 Day 1 Day 2 Day 1 Day 2 Sequence A CMNC MNC MNC CMNC Sequence B MNC CMNC CMNC MNC There might be some carry over effect between procedure 1 and 2 within each cycle, because during the procedure the patient is administered fluids, and therefore cell counts/ml in the second day might be lower than in the first day; this it is intrinsic to the clinical procedure and can not be modified, but will be taken into account in statistical analyses. Carry over effect between first and second cycle is not expected, since they are performed at least 7 days apart; this allow the patient's cell blood count to be restored to baseline values; however, this will also be considered in statistical analyses.

Official Title
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Comparison of Two Automated Mononuclear Collection Systems (Spectra Optia CMNC and MNC) in Patients Undergoing Extracorporeal Photochemotherapy. A Cross-over Equivalence Study.

Conditions
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GvHD, Lung Graft Dysfunction

Intervention / Treatment
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* Device: Spectra Optia


Participation Criteria
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Eligibility Criteria
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adult (>18 years) patients undergoing extracorporeal photochemotherapy for either CLAD or GvHD Inclusion criteria: age >18 years on extracorporeal photochemotherapy for either CLAD or GvHD exclusion criteria: age <18 years,

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CMNC<br>the very recently released Spectra Optia CMNC (developed especially to collect stem cells that reside in the MNCs layer) is able to collect MNCs by continuous flow. | Device: Spectra Optia<br>* The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself, 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. Terumo BCT developed a completely automated apheresis system: the Spectra Optia MNC and CMNC based on an automatic interface-controlled technology that allows MNCs collection without the intervention of an operator. The optical sensors continuously control and adjust the buffy coat layer by adjusting the plasma flow. The Spectra Optia MNC collects MNCs by intermittent flow: MNCs accumulate and are flushed from a secondary chamber at intervals during the procedure. On the other hand, the very recently released Spectra Optia CMNC (developed especially to collect stem cells that reside in the MNCs layer) is able to collect MNCs by continuous flow.<br>* Other names: Terumo BCT;|
| Active Comparator: MNC<br>The Spectra Optia MNC collects MNCs by intermittent flow: MNCs accumulate and are flushed from a secondary chamber at intervals during the procedure. | Device: Spectra Optia<br>* The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself, 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. Terumo BCT developed a completely automated apheresis system: the Spectra Optia MNC and CMNC based on an automatic interface-controlled technology that allows MNCs collection without the intervention of an operator. The optical sensors continuously control and adjust the buffy coat layer by adjusting the plasma flow. The Spectra Optia MNC collects MNCs by intermittent flow: MNCs accumulate and are flushed from a secondary chamber at intervals during the procedure. On the other hand, the very recently released Spectra Optia CMNC (developed especially to collect stem cells that reside in the MNCs layer) is able to collect MNCs by continuous flow.<br>* Other names: Terumo BCT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Yield of MNCs | absolute number of MNC/ml in bag | on average at 1 month from ECP start | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Collection efficiency (%) | MNC Collection efficiency % | on average at 1 month from ECP start | 
| purity | percentage of MNC/ml in bag content | on average at 1 month from ECP start | 
| safety as change in platelet count in peripheral blood | patient's platelet loss | single timepoint point: 10 minutes after MNC collection |