Two Different Collection Sets for Peripheral Blood Progenitor Cell Apheresis With Spectra Optia® (optiMaL)

Prospective Randomized Trial Comparing Efficiency of Peripheral Blood Progenitor Cell Collection in Allogeneic Donors Using the Spectra Optia® IDL Set in Comparison With the Spectra Optia® MNC Collection Set

The study will determine the advantage of the Spectra Optia® IDL set compared to the standard collection set for collection of peripheral blood progenitor cells using the Spectra Optia® apheresis system. The study will assess the reduction of apheresis time to obtain the required amount of hematopoietic progenitor cells.

Study Overview

• Status: Completed
• Conditions: Healthy Allogeneic Donors; Granulocyte Colony-stimulating Factor (G-CSF) Mobilized
• Intervention / Treatment: Device: Spectra Optia® IDL-Set; Device: Spectra Optia® Collection Set

Detailed Description

Peripheral blood progenitor cells (PBPC) collected by apheresis are the most common stem cell source for allogeneic hematopoietic stem cell transplantation.

Recently, Terumo BCT introduced a novel automated apheresis system for PBPC collection. The Spectra Optia® apheresis system uses the Spectra Optia® Collection set and the MNC software for PBPC collection. This system combines continuous centrifugation (high g) and subsequent cellular collection into an elutriation chamber, where the platelets are elutriated from mononuclear cells. An optical sensor detects when red blood cells begin to be elutriated and subsequently triggers the collection of the buffy coat into the product bag by flushing the chamber with donor plasma. Thus PBPCs are harvested intermittently. In contrast, the same apheresis systems in combination with the Spectra Optia® IDL set and the WBC-D software, which has been designed to perform leukodepletion procedures, permits continuous PBPC centrifugation (low g) and harvesting.

The investigators hypothesis is that the use of the IDL set with manual adaption of the WBC-D-software allows a more efficient PBPC collection compared to the collection set which is recommended for PBPC collection. The apheresis time to collect the same amount of target cells dependent on the donors peripheral blood count will be shortened. In addition, the investigators want to compare both systems with respect to the cellular composition of the apheresis product and the donors platelet loss and coagulation parameters during apheresis.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Cologne, Germany, 50670
    • Cellex GmbH / Zentrum für Zellgewinnung (Standort Köln)
  • Duesseldorf, Germany, 40225
    • Institut für Transplantantionsdiagnostik und Zelltherapeutika

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 58 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• ability to give informed consent to participate in the study
• meets german eligibility criteria (ZKRD-Standards, hemotherapy guidelines) for peripheral blood stem cell donation
• has been treated with G-CSF 10 µg per kg per day for 5 days

Exclusion Criteria:

• demand of concurrent plasma

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IDL-Set; Peripheral blood progenitor cell apheresis in G-CSF mobilized allogeneic donors using the Spectra Optia® IDL-Set in combination with the Spectra Optia® cell separator and the WBC-D program	Device: Spectra Optia® IDL-Set; Peripheral blood progenitor cell apheresis in G-CSF mobilized allogeneic donors using the Spectra Optia® cell separator
Active Comparator: MNC-Set; Peripheral blood progenitor cell apheresis in G-CSF mobilized allogeneic donors using the Spectra Optia® Collection Set in combination with the Spectra Optia® cell separator and the MNC program	Device: Spectra Optia® Collection Set; Peripheral blood progenitor cell apheresis in G-CSF mobilized allogeneic donors using the Spectra Optia® cell separator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Throughput (TP)	Efficiency of peripheral blood progenitor cell collection measured as throughput (collection rate (CR) per minute)	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CR per total blood volume (TBV)	Efficiency of peripheral blood progenitor cell collection measured as CR per TBV	Day 1
Collection efficiency (CE) 1	Percentage of harvested cells per processed cells (calculated by use of the peripheral blood progenitor cell counts pre and post apheresis)	Day 1
CE2	Percentage of harvested cells per processed cells (calculated by use of the peripheral blood progenitor cell count pre apheresis)	Day 1
Product T cells	% T cells as a definition of the cellular composition of the product	Day 1
Product NK cells	% NK cells as a definition of the cellular composition of the product	Day 1

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
levels of electrolytes before and after apheresis	sodium, potassium and calcium are measured before and after apherese and 30 days after collection	day 1, day 30
kinetics of peripheral blood cell count	measurement of the peripheral blood cell count before and after apheresis and 30 days after collection	day 1, day30
Peripheral blood CD62P before and after apheresis	Percentage of CD62P positive platelets as a measure of platelet activation during apheresis	day 1

Collaborators and Investigators

• Sponsor: Heinrich-Heine University, Duesseldorf
• Collaborators: Chugai Pharma USA; Terumo BCT
• Investigators: Principal Investigator: Johannes C Fischer, MD, Heinrich Heine University Hospital Duesseldorf

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: July 10, 2013
• First Submitted That Met QC Criteria: July 15, 2013
• First Posted (Estimate): July 17, 2013

Study Record Updates

• Last Update Posted (Estimate): March 19, 2015
• Last Update Submitted That Met QC Criteria: March 18, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: apheresis; peripheral blood progenitor cells; peripheral blood stem cells
• Other Study ID Numbers: ITZ-003; CIV-13-10-011663 (Other Identifier: EUDAMED)