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

GvHD Clinical Trial

— CMNC_MNC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02490163
• Other study ID #: doc20150414113301_CDF
• Status: Completed
• Phase: Phase 3
• First received: May 28, 2015
• Last updated: January 8, 2016
• Start date: August 2015
• Est. completion date: January 2016

Study information

• Verified date: January 2016
• Source: IRCCS Policlinico S. Matteo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: January 2016
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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,

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• GvHD
• Lung Graft Dysfunction

Intervention

Device:
• Spectra Optia
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.

Locations

Country	Name	City	State
Italy	IRCCS Policlinic San Matteo Foundation	Pavia

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Policlinico S. Matteo

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Yield of MNCs in GvDH vs CLAD	absolute number of MNC/ml in bag in the two groups	on average at 1 month from ECP start	No
Primary	Yield of MNCs	absolute number of MNC/ml in bag	on average at 1 month from ECP start	No
Secondary	Collection efficiency (%)	MNC Collection efficiency %	on average at 1 month from ECP start	No
Secondary	purity	percentage of MNC/ml in bag content	on average at 1 month from ECP start	No
Secondary	safety as change in platelet count in peripheral blood	patient's platelet loss	single timepoint point: 10 minutes after MNC collection	Yes