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

Phase 3

Completed

• Conditions: GvHD; Lung Graft Dysfunction
• Interventions: Device: Spectra Optia

• Registration Number: NCT02490163
• Lead Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2015-05-28
• Study First Submitted QC: 2015-07-02
• Study First Posted: 2015-07-03
• Study Start: 2015-08
• Primary Completion: 2015-11
• Status Verified: 2016-01
• Study Completion: 2016-01
• Last Update Submitted: 2016-01-08
• Last Update Posted: 2016-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
CMNC	Spectra Optia	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.
MNC	Spectra Optia	The Spectra Optia MNC collects MNCs by intermittent flow: MNCs accumulate and are flushed from a secondary chamber at intervals during the procedure.

Primary Outcome Measures

Name	Time	Method
Yield of MNCs	on average at 1 month from ECP start	absolute number of MNC/ml in bag

Secondary Outcome Measures

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

Trial Locations

Locations (1)

IRCCS Policlinic San Matteo Foundation; 🇮🇹 Pavia, Italy