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Outpatient Treatment with Lisocabtagene Maraleucel (liso-cel) in 3 Ongoing Clinical Studies in Relapsed/Refractory (R/R) Large B Cell Non-Hodgkin Lymphoma (NHL), Including Second-Line Transplant Noneligible (TNE) Patients: Transcend NHL 001, Outreach, and PILOT

CAR T cell therapy has generally been limited to inpatient treatment. Infusion and management of CAR T cell therapy in the outpatient setting may lead to wider use in nonuniversity centers and improved access. We report on patients (pts) with R/R large B cell NHL treated with liso-cel in the outpati...

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Published in:Biology of blood and marrow transplantation 2020-03, Vol.26 (3), p.S25-S26
Main Authors: Bachier, Carlos R., Palomba, M. Lia, Abramson, Jeremy S., Andreadis, Charalambos, Sehgal, Alison, Godwin, John, Hildebrandt, Gerhard C, Siddiqi, Tanya, Stevens, Don, Farazi, Thalia, Kostic, Ana, Trede, Nikolaus S, Wang, Lei, Lymp, James, Thelen, Tennille, Ogasawara, Ken, Maloney, David G.
Format: Article
Language:English
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Summary:CAR T cell therapy has generally been limited to inpatient treatment. Infusion and management of CAR T cell therapy in the outpatient setting may lead to wider use in nonuniversity centers and improved access. We report on patients (pts) with R/R large B cell NHL treated with liso-cel in the outpatient setting in TRANSCEND NHL 001 (NCT02631044) and two phase 2 studies (≥3rd-line therapy: OUTREACH, NCT03744676; 2nd-line TNE: PILOT, NCT03483103). Eligible pts had R/R large B cell NHL (TRANSCEND/OUTREACH: ≥2 lines of prior therapy and ECOG PS ≤1; PILOT: 1 line of prior therapy and deemed TNE for autologous hematopoietic stem cell transplant based on ECOG PS, organ function, or age). After lymphodepletion with fludarabine/cyclophosphamide, liso-cel was administered. All studies allowed outpatient treatment at nonuniversity (OUTREACH) or university and nonuniversity medical centers (TRANSCEND/PILOT), with hospitalization at the first sign of fever or neurological events (NEs) per management guidelines. At data cutoff, 37 pts across studies received liso-cel on study Day 1 and were monitored as outpatients, including pts aged ≥65 years (n = 15) and those with SPD ≥50 cm2 (n = 10) or LDH ≥500 UL (n = 2). Results are shown in the Table. Sixteen pts had any grade cytokine release syndrome (CRS) and 12 had any grade NEs (19 pts had CRS and/or NEs). Only 2 pts had had grade 3 or 4 CRS or NEs, which were reversible. Three pts received tocilizumab and corticosteroids for CRS and/or NEs; none received tocilizumab alone. Overall, 59% of pts (n = 22/37) required hospitalization at any time; all were from TRANSCEND or OUTREACH. Of 37 pts, 3 (8%) were admitted on study Day 3 or earlier (all for CRS) and 1 (3%) required ICU-level care (length of stay, 3 days). Median time to hospitalization post treatment was 5 (range, 2‒22) days; median length of stay was 6 (range, 2‒23) days. Overall, 41% of pts (15/37), including all 5 pts from PILOT, did not require hospitalization in the first 29 days post liso-cel infusion. Across all studies, most pts achieved an objective response (76%), including complete responses. A subset of pts with R/R large B cell NHL were successfully treated with liso-cel and monitored for CAR T cell–related toxicity in the outpatient setting, including elderly pts and pts with high tumor burden. Incidences of severe CRS, NEs, and early hospitalization were low; 41% of pts did not require hospitalization in the first month post treatment. Most pts achieved a
ISSN:1083-8791
1523-6536
DOI:10.1016/j.bbmt.2019.12.093