Clinical trial NCT01901458: Two Different Collection Sets for Peripheral Blood Progenitor Cell Apheresis With Spectra Optia®
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Allogeneic Donors
Granulocyte Colony-stimulating Factor (G-CSF) Mobilized
Keywords: apheresis
peripheral blood progenitor cells
peripheral blood stem cells
Lead sponsor: Heinrich-Heine University, Duesseldorf
Sponsor class: OTHER
Collaborators: name: Terumo BCT
name: Chugai Pharma USA
First posted: 2013-07-17
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Throughput (TP)
timeFrame: Day 1
Secondary outcomes:
measure: CR per total blood volume (TBV)
timeFrame: Day 1
measure: Collection efficiency (CE) 1
timeFrame: Day 1
measure: CE2
timeFrame: Day 1
measure: Product T cells
timeFrame: Day 1
measure: Product NK cells
timeFrame: Day 1
Other outcomes:
measure: levels of electrolytes before and after apheresis
timeFrame: day 1, day 30
measure: kinetics of peripheral blood cell count
timeFrame: day 1, day30
measure: Peripheral blood CD62P before and after apheresis
timeFrame: day 1
Locations:
city: Cologne
country: Germany
facility: Cellex GmbH / Zentrum für Zellgewinnung (Standort Köln)
city: Duesseldorf
country: Germany
facility: Institut für Transplantantionsdiagnostik und Zelltherapeutika
Study officials:
affiliation: Heinrich Heine University Hospital Duesseldorf
name: Johannes C Fischer, MD
role: PRINCIPAL_INVESTIGATOR
References: