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NCT Number: NCT02490163

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

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.

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Key information

Conditions

GVHD Lung Graft Dysfunction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

IRCCS Policlinic San Matteo Foundation

Pavia, 27100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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,

Treatment and study plan

Spectra Optia

Device

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.

Other names: Terumo BCT

Primary outcomes

  1. Yield of MNCs

    Time frame: on average at 1 month from ECP start

    absolute number of MNC/ml in bag

Secondary outcomes

  1. Collection efficiency (%)

    Time frame: on average at 1 month from ECP start

    MNC Collection efficiency %

  2. purity

    Time frame: on average at 1 month from ECP start

    percentage of MNC/ml in bag content

  3. safety as change in platelet count in peripheral blood

    Time frame: single timepoint point: 10 minutes after MNC collection

    patient's platelet loss

Other outcomes

  1. Yield of MNCs in GvDH vs CLAD

    Time frame: on average at 1 month from ECP start

    absolute number of MNC/ml in bag in the two groups

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia

Other

Registry information

Official study title

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

Acronym: CMNC_MNC

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Jul 3, 2015
Registry last updated
Jan 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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