FRINK Linked Data Fragments server

Matches in SemOpenAlex for { <https://semopenalex.org/work/W4310125688> ?p ?o ?g. }

• W4310125688 endingPage "10418" @default.
• W4310125688 startingPage "10416" @default.
• W4310125688 abstract "Background: CAR T cell therapies are generally administered in inpt settings owing to concerns of AE management. Prospective data on treatment and outcomes with CAR T cell therapy, encompassing infusion and outpt monitoring, in community settings is of interest. Liso-cel is an autologous, CD19-directed, 4-1BB CAR T cell product administered at equal target doses of CD8+ and CD4+ CAR+ T cells. In TRANSCEND NHL 001 (NCT02631044) in pts with third-line or later LBCL, liso-cel showed meaningful efficacy (ORR, 73%; CR rate, 53%) and a manageable safety profile (grade [gr] ≥ 3 cytokine release syndrome [CRS], 2%; gr ≥ 3 neurological events [NE], 10%; gr ≥ 3 prolonged cytopenia, 37%; gr ≥ 3 infections, 12%) (Abramson et al. Lancet 2020). Here we present an update from OUTREACH (NCT03744676), which evaluated liso-cel in pts with R/R LBCL (a population similar to TRANSCEND NHL 001) across outpt and inpt settings at community sites in the United States. The primary analysis (PA) will be presented at the meeting. Methods: Adults with R/R PET-positive LBCL after ≥ 2 lines of therapy and ECOG PS ≤ 1 were enrolled at community sites. Pts with gr 3‒4 cytopenias, mild-moderate organ dysfunction (LVEF ≥ 40%; serum CrCl > 30 mL/min), secondary CNS lymphoma, and prior autologous HSCT were eligible. After leukapheresis and lymphodepleting chemotherapy (LDC), pts received liso-cel at a target dose of 100 × 106 CAR+ T cells. Outpt versus inpt monitoring was at the investigator's discretion. Primary endpoint (safety) was incidence of gr ≥ 3 CRS, NEs, prolonged cytopenias (Day 29 gr ≥ 3 laboratory values), and infections. Secondary endpoints included safety, ORR, CR rate, duration of response (DOR), and PFS. CRS was graded per Lee 2014 criteria. Study sites had a multidisciplinary CAR T cell therapy team and standard operating procedures (SOP) for outpt monitoring of toxicity and admission for CRS/NE management. Pts had to have a caregiver and stay ≤ 1 h travel time to study site. Results: At data cutoff, 79 pts received liso-cel at community sites, with 66%/34% at FACT/non-FACT sites, including CAR T-inexperienced sites; 54 (68%) pts were monitored as outpts and 25 (32%) as inpts. Median age was 66 y (range, 28‒86; ≥ 65 y, 53%); 61% of pts had DLBCL NOS, 68% had screening ECOG PS 1, and 3% had secondary CNS lymphoma. Pts received a median of 2 prior lines of systemic therapy (range, 2‒6), 34% had ≥ 3 prior therapies, 82% were chemotherapy refractory, and 53% received bridging therapy. 28% had LDH ≥ 500 U/L and 38% had sum of the product of perpendicular diameters (SPD) ≥ 50 cm2 before LDC. Most common reasons for inpt monitoring (n = 25) were disease characteristics (40%), investigator decision (32%), distance from site (12%), or no caregiver support (8%). Most common treatment-emergent AEs were neutropenia (68%), leukopenia (44%), CRS (39%), thrombocytopenia (35%), anemia (33%), and fatigue (30%). No gr ≥ 3 CRS was reported. Any-grade NEs occurred in 30% (gr 3‒4, 10%). 28% of pts received tocilizumab and/or corticosteroids for CRS or NEs (Table). In outpts and inpts, respectively, any-grade CRS was reported in 37% and 44%, NEs in 30% and 32% (gr ≥ 3 in 13% and 4%), infections in 33% and 32% (gr ≥ 3 in 13% and 4%) and gr ≥ 3 prolonged cytopenias in 33% and 32%. For outpts, 24% were never hospitalized after infusion, 31% were hospitalized ≤ 4 days after infusion, and median time to hospitalization was 5.0 (range, 2‒310) days. Reasons for admission were AEs (63%) and other (13%). Two (4%) outpts were admitted to ICU during initial hospital stay (median [range] time in ICU, 3.5 [2‒5] days). Median (range) duration of initial hospital stay after liso-cel was 6.0 (1‒28) days (n = 41) for outpts and 13.0 (1‒31) days (n = 25) for inpts. All pts were efficacy evaluable. ORR was 80% (CR rate, 52%) (Table). Longer follow-up, DOR, and PFS will be presented for the PA. Conclusions: Pts with R/R LBCL treated with liso-cel were successfully infused and monitored as outpts in the community setting using SOPs and multidisciplinary teams. Liso-cel demonstrated clinical activity with a manageable safety profile in both outpts and inpts regardless of prior HSCT. 24% of outpts were never hospitalized after liso-cel infusion and only 31% were hospitalized ≤ 4 days after infusion. These data, along with shorter hospital stays in outpts vs inpts, suggest CAR T cell therapy costs could be reduced by outpt monitoring at qualified sites. The data support liso-cel monitoring at community sites and in the outpt setting. Figure 1View largeDownload PPTFigure 1View largeDownload PPT Close modal" @default.
• W4310125688 created "2022-11-30" @default.
• W4310125688 creator A5001172723 @default.
• W4310125688 creator A5001198370 @default.
• W4310125688 creator A5005446862 @default.
• W4310125688 creator A5008759107 @default.
• W4310125688 creator A5009390327 @default.
• W4310125688 creator A5014213278 @default.
• W4310125688 creator A5023980350 @default.
• W4310125688 creator A5024431512 @default.
• W4310125688 creator A5026503525 @default.
• W4310125688 creator A5029530100 @default.
• W4310125688 creator A5029900394 @default.
• W4310125688 creator A5030404045 @default.
• W4310125688 creator A5043537720 @default.
• W4310125688 creator A5044422916 @default.
• W4310125688 creator A5046354300 @default.
• W4310125688 creator A5062272590 @default.
• W4310125688 creator A5066180365 @default.
• W4310125688 creator A5067771775 @default.
• W4310125688 creator A5072266160 @default.
• W4310125688 date "2022-11-15" @default.
• W4310125688 modified "2023-09-28" @default.
• W4310125688 title "Results from Outreach: A Phase 2 Study of Lisocabtagene Maraleucel (Liso-cel) Administered As Outpatient (Outpt) or Inpatient (Inpt) Treatment in the Community/Nonuniversity Setting in Patients (Pts) with Relapsed or Refractory (R/R) Large B-Cell Lymphoma (LBCL)" @default.
• W4310125688 doi "https://doi.org/10.1182/blood-2022-159595" @default.
• W4310125688 hasPublicationYear "2022" @default.
• W4310125688 type Work @default.
• W4310125688 citedByCount "0" @default.
• W4310125688 crossrefType "journal-article" @default.
• W4310125688 hasAuthorship W4310125688A5001172723 @default.
• W4310125688 hasAuthorship W4310125688A5001198370 @default.
• W4310125688 hasAuthorship W4310125688A5005446862 @default.
• W4310125688 hasAuthorship W4310125688A5008759107 @default.
• W4310125688 hasAuthorship W4310125688A5009390327 @default.
• W4310125688 hasAuthorship W4310125688A5014213278 @default.
• W4310125688 hasAuthorship W4310125688A5023980350 @default.
• W4310125688 hasAuthorship W4310125688A5024431512 @default.
• W4310125688 hasAuthorship W4310125688A5026503525 @default.
• W4310125688 hasAuthorship W4310125688A5029530100 @default.
• W4310125688 hasAuthorship W4310125688A5029900394 @default.
• W4310125688 hasAuthorship W4310125688A5030404045 @default.
• W4310125688 hasAuthorship W4310125688A5043537720 @default.
• W4310125688 hasAuthorship W4310125688A5044422916 @default.
• W4310125688 hasAuthorship W4310125688A5046354300 @default.
• W4310125688 hasAuthorship W4310125688A5062272590 @default.
• W4310125688 hasAuthorship W4310125688A5066180365 @default.
• W4310125688 hasAuthorship W4310125688A5067771775 @default.
• W4310125688 hasAuthorship W4310125688A5072266160 @default.
• W4310125688 hasBestOaLocation W43101256881 @default.
• W4310125688 hasConcept C121332964 @default.
• W4310125688 hasConcept C126322002 @default.
• W4310125688 hasConcept C142424586 @default.
• W4310125688 hasConcept C17744445 @default.
• W4310125688 hasConcept C199539241 @default.
• W4310125688 hasConcept C2781400479 @default.
• W4310125688 hasConcept C31760486 @default.
• W4310125688 hasConcept C512399662 @default.
• W4310125688 hasConcept C535046627 @default.
• W4310125688 hasConcept C71924100 @default.
• W4310125688 hasConcept C87355193 @default.
• W4310125688 hasConceptScore W4310125688C121332964 @default.
• W4310125688 hasConceptScore W4310125688C126322002 @default.
• W4310125688 hasConceptScore W4310125688C142424586 @default.
• W4310125688 hasConceptScore W4310125688C17744445 @default.
• W4310125688 hasConceptScore W4310125688C199539241 @default.
• W4310125688 hasConceptScore W4310125688C2781400479 @default.
• W4310125688 hasConceptScore W4310125688C31760486 @default.
• W4310125688 hasConceptScore W4310125688C512399662 @default.
• W4310125688 hasConceptScore W4310125688C535046627 @default.
• W4310125688 hasConceptScore W4310125688C71924100 @default.
• W4310125688 hasConceptScore W4310125688C87355193 @default.
• W4310125688 hasIssue "Supplement 1" @default.
• W4310125688 hasLocation W43101256881 @default.
• W4310125688 hasOpenAccess W4310125688 @default.
• W4310125688 hasPrimaryLocation W43101256881 @default.
• W4310125688 hasRelatedWork W2068316626 @default.
• W4310125688 hasRelatedWork W2110818089 @default.
• W4310125688 hasRelatedWork W2351796763 @default.
• W4310125688 hasRelatedWork W2351985199 @default.
• W4310125688 hasRelatedWork W2403502999 @default.
• W4310125688 hasRelatedWork W2567738959 @default.
• W4310125688 hasRelatedWork W2923882796 @default.
• W4310125688 hasRelatedWork W2954318774 @default.
• W4310125688 hasRelatedWork W4297834875 @default.
• W4310125688 hasRelatedWork W4366141624 @default.
• W4310125688 hasVolume "140" @default.
• W4310125688 isParatext "false" @default.
• W4310125688 isRetracted "false" @default.
• W4310125688 workType "article" @default.