PMID- 36655281
OWN - NLM
STAT- MEDLINE
DCOM- 20230706
LR  - 20230706
IS  - 1098-1101 (Electronic)
IS  - 0733-2459 (Linking)
VI  - 38
IP  - 4
DP  - 2023 Aug
TI  - Safety and performance of the Spectra Optia apheresis system for white blood cell 
      depletion in patients with elevated white blood cell counts.
PG  - 396-405
LID - 10.1002/jca.22038 [doi]
AB  - BACKGROUND: For the past 30 years, white blood cell depletion (WBCD) or 
      leukocytapheresis has been conducted to rapidly reduce excessive circulating 
      white blood cell (WBC) concentrations in patients at risk for or with symptoms of 
      leukostasis due to hyperleukocytosis. The goal of leukocytapheresis is to prevent 
      or treat acute complications from leukostasis, thereby enabling patients to 
      receive potentially curative chemotherapy. METHODS: This report details the 
      results from a retrospective and a prospective clinical study conducted in the 
      European Union and the People's Republic of China, which assessed the use of the 
      Spectra Optia Apheresis System for leukocytapheresis in patients with 
      hyperleukocytosis. The primary objective of both studies was to the assess the 
      safety and performance of the WBCD procedure in patients with elevated WBC 
      counts. RESULTS: Data were collected from 72 participants completing 87 WBCD 
      procedures. The mean percent change in participant WBC counts post-procedure was 
      50.3 +/- 21.2% and the collection efficiency (CE1) of the WBCD procedures was 
      53.7 +/- 19.8%. Sixty-one participants (95.3%) experienced a total of 279 adverse 
      events (AEs) with the majority of the AEs related to post-procedure changes in 
      laboratory values, which is an anticipated AE in this patient population. 
      CONCLUSION: The data collected within these studies indicate that the WBCD 
      procedure is safe and well tolerated in patients with hyperleukocytosis as 
      evaluated by percent decrease in WBC count, CE1, and AE incidence.
CI  - (c) 2023 Terumo BCT. Journal of Clinical Apheresis published by Wiley Periodicals 
      LLC.
FAU - Lopert, Pamela
AU  - Lopert P
AUID- ORCID: 0000-0002-6625-7832
AD  - Terumo BCT, Inc., Lakewood, Colorado, USA.
FAU - Abdelrahman, Sohair
AU  - Abdelrahman S
AD  - Terumo BCT, Inc., Lakewood, Colorado, USA.
FAU - Graybill, Christopher A
AU  - Graybill CA
AD  - Terumo BCT, Inc., Lakewood, Colorado, USA.
FAU - Rhodes, Jack
AU  - Rhodes J
AD  - Terumo BCT, Inc., Lakewood, Colorado, USA.
FAU - Dierickx, Daan
AU  - Dierickx D
AD  - UZ Leuven, Leuven, Belgium.
FAU - Schafer, Richard
AU  - Schafer R
AD  - Institute for Transfusion Medicine and Immunohaematology, German Red Cross Blood 
      Donor Service Baden-Wurttemberg-Hessen gGmbH, Frankfurt, Germany.
FAU - Reti, Marienn
AU  - Reti M
AD  - Central Hospital of Southern Pest, National Institute of Hematology and 
      Infectious Diseases, Szent Laszla Hospital Campus, Budapest, Hungary.
FAU - Wu, Depei
AU  - Wu D
AD  - The First Affiliated Hospital of Soochow University, Suzhou, China.
FAU - Hu, Yu
AU  - Hu Y
AD  - Wuhan Union Hospital, Wuhan, China.
FAU - Huang, Fen
AU  - Huang F
AD  - Nanfang Hospital, Guangzhou, China.
FAU - Hu, Jianda
AU  - Hu J
AD  - Fujian Medical University Union Hospital, Fujian, China.
FAU - He, Pengcheng
AU  - He P
AD  - The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.
FAU - Liu, Ligen
AU  - Liu L
AD  - Tongren Hospital Shanghai Jiaotong University School of Medicine, Shanghai, 
      China.
FAU - Li, Ming
AU  - Li M
AD  - The Second People's Hospital of Shenzhen, Shenzhen, China.
FAU - Zhang, Xuejun
AU  - Zhang X
AD  - The Second Hospital of Hebei Medical University, Xi'an, China.
FAU - Bill, Jerry
AU  - Bill J
AD  - Terumo BCT, Inc., Lakewood, Colorado, USA.
LA  - eng
GR  - Terumo BCT/
PT  - Journal Article
DEP - 20230118
PL  - United States
TA  - J Clin Apher
JT  - Journal of clinical apheresis
JID - 8216305
SB  - IM
MH  - Humans
MH  - *Leukostasis/therapy
MH  - Retrospective Studies
MH  - Prospective Studies
MH  - Leukocytes
MH  - Leukapheresis/methods
MH  - Leukocyte Count
OTO - NOTNLM
OT  - hyperleukocytosis
OT  - leukemia
OT  - leukocytapheresis
OT  - leukocyte depletion
OT  - leukocytes
OT  - leukostasis
OT  - therapeutic apheresis
EDAT- 2023/01/20 06:00
MHDA- 2023/07/06 06:42
CRDT- 2023/01/19 02:05
PHST- 2022/12/14 00:00 [revised]
PHST- 2022/03/04 00:00 [received]
PHST- 2022/12/15 00:00 [accepted]
PHST- 2023/07/06 06:42 [medline]
PHST- 2023/01/20 06:00 [pubmed]
PHST- 2023/01/19 02:05 [entrez]
AID - 10.1002/jca.22038 [doi]
PST - ppublish
SO  - J Clin Apher. 2023 Aug;38(4):396-405. doi: 10.1002/jca.22038. Epub 2023 Jan 18.