Effectiveness of supplemental oral calcium drink in preventing citrate-related adverse effects in peripheral blood progenitor cell collection

Fujii, Keiko; Fujii, Nobuharu; Kondo, Takumi; Mitsuhashi, Toshiharu; Nakamura, Makoto; Seike, Keisuke; Sando, Yasuhisa; Kimura, Maiko; Matsuda, Masayuki; Ikegawa, Shuntaro; Sugiura, Hiroyuki; Otsuka, Fumio; Maeda, Yoshinobu

doi:10.1016/j.transci.2021.103147

Cited by 6 publications

(4 citation statements)

References 16 publications

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“…In addition, some patients received a prophylactic oral calcium supplement (beverage containing 260 mg of ionized calcium; Calgen Pharmaceuticals, Osaka, Japan) just before the start of leukapheresis to prevent citrate toxicity. Experienced physicians assessed hypocalcemic symptoms such as dysesthesia, cramps, and nausea and graded them using the previously described approach 27,28 …”

Section: Study Design and Methodsmentioning

confidence: 99%

“…Experienced physicians assessed hypocalcemic symptoms such as dysesthesia, cramps, and nausea and graded them using the previously described approach. 27,28 The patients' TBV was provided by the Spectra Optia device calculator. The processing blood volume (PBV) for each leukapheresis was determined by the attending physician based on the pre-apheresis PB CD3 + cell counts, targeting the collection of 2-3 Â 10 9 CD3 + cells (as it has been reported that 31.3% of the manufacturing failure when only <2 Â 10 9 CD3 + cells were collected 23 ), and the assumed CD3 + collection efficiency 2 (CE2) of 30-50% (because of empirical establishment that all of leukaphereses will achieve a CE2 of 30% or greater [see below]).…”

Section: Apheresis Proceduresmentioning

confidence: 99%

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Collection efficiency and safety of large‐volume leukapheresis for the manufacturing of tisagenlecleucel

Kitamura,

Urata,

Fujii

et al. 2024

Transfusion

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BackgroundIn patients with relapsed or refractory B cell acute lymphoblastic leukemia or B cell non‐Hodgkin lymphoma (r/r B‐ALL/B‐NHL) with low CD3+ cells in the peripheral blood (PB), sufficient CD3+ cell yield in a single day may not be obtained with normal‐volume leukapheresis (NVL). Large‐volume leukapheresis (LVL) refers to the processing of more than three times the total blood volume (TBV) in a single session for PB apheresis; however, the efficiency and safety of LVL for manufacturing of tisagenlecleucel (tisa‐cel) remain unclear. This study aimed to investigate the tolerability of LVL.Study Design and MethodsWe retrospectively collected data on LVL (≥3‐fold TBV) and NVL (<3‐fold TBV) performed for patients with r/r B‐ALL/B‐NHL in our institution during November 2019 and September 2023. All procedures were performed using a continuous mononuclear cell collection (cMNC) protocol with the Spectra Optia.ResultsAlthough pre‐apheresis CD3+ cells in the PB were significantly lower in LVL procedures (900 vs. 348/μL, p < .01), all patients could obtain sufficient CD3+ cell yield in a single day with a comparably successful rate of final products (including out‐of‐specification) between the two groups (97.2% vs. 100.0%, p = 1.00). The incidence and severity of citrate toxicity (no patients with grade ≥ 3) during procedures was not significantly different between the two groups (22.2% vs. 26.1%, p = .43) and no patient discontinued leukapheresis due to any complications.ConclusionLVL procedures using Spectra Optia cMNC protocol was well tolerated and did not affect the manufacturing of tisa‐cel.

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Section: Study Design and Methodsmentioning

confidence: 99%

Section: Apheresis Proceduresmentioning

confidence: 99%

Collection efficiency and safety of large‐volume leukapheresis for the manufacturing of tisagenlecleucel

Kitamura,

Urata,

Fujii

et al. 2024

Transfusion

Self Cite

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“…For patients who are intubated, sedated, or who did not improve with oral calcium, intravenous calcium can be given for symptom relief and maintained through the collection 52 . The importance of maintaining ionized calcium at or above the normal range is indicated by the few adverse events otherwise encountered during collections when calcium is optimized 53,54 …”

Section: Cell Collectionsmentioning

confidence: 99%

“…52 The importance of maintaining ionized calcium at or above the normal range is indicated by the few adverse events otherwise encountered during collections when calcium is optimized. 53,54…”

Section: Calcium Optimizationmentioning

confidence: 99%

Apheresis collection of mononuclear cells for chimeric‐antigen receptor therapies

Maitta

2023

European J of Haematology

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Collections of lymphocytes to be genetically modified to treat hematologic malignancies have seen a dramatic increase over the last few years as commercial products have been approved. Reports of new products in development that can possibly treat solid organ malignancies represent a massive change in the field. Apheresis is at the center of the collection of cells for the manufacture of these chimeric‐antigen receptor therapy products. The expansion of these collections represents one of the areas of apheresis procedures growth. This review will summarize concepts important to this type of collection and variables that need to be optimized to obtain desired cell yields while increasing patients' safety.

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Collection of Hematopoietic Stem Cells and Cell Therapy Products

Maitta

2024

Comprehensive Hematology and Stem Cell Research

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Effectiveness of supplemental oral calcium drink in preventing citrate-related adverse effects in peripheral blood progenitor cell collection

Cited by 6 publications

References 16 publications

Collection efficiency and safety of large‐volume leukapheresis for the manufacturing of tisagenlecleucel

Collection efficiency and safety of large‐volume leukapheresis for the manufacturing of tisagenlecleucel

Apheresis collection of mononuclear cells for chimeric‐antigen receptor therapies

Collection of Hematopoietic Stem Cells and Cell Therapy Products

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