FRINK Linked Data Fragments server

Matches in SemOpenAlex for { <https://semopenalex.org/work/W4386087005> ?p ?o ?g. }

• W4386087005 endingPage "e3278692" @default.
• W4386087005 startingPage "e3278692" @default.
• W4386087005 abstract "Topic: 19. Aggressive Non-Hodgkin lymphoma - Clinical Background: The nearly 40% of patients with large B-cell lymphoma (LBCL) who are refractory to or relapse after current first-line standard-of-care (SOC) regimens, such as R-CHOP (rituximab [R] + cyclophosphamide [C], doxorubicin [H], vincristine [O], and prednisone [P]) and DA-EPOCH-R (dose-adjusted etoposide [DA-E]), have poor prognoses. High International Prognostic Index (IPI) score and the subtype of high-grade B-cell lymphoma are associated with shorter progression-free and overall survival (PFS and OS; Nastoupil LJ and Bartlett NL. J Clin Oncol. 2023). Strategies to improve outcomes in these subgroups have been largely unsuccessful; therefore, therapeutic options with a different mechanism of action are needed. Axicabtagene ciloleucel (axi-cel) is an autologous anti-CD19 chimeric antigen receptor (CAR) T-cell therapy approved to treat patients with relapsed/refractory LBCL after demonstrating significant clinical benefit as 2L (ZUMA-7; Locke FL, et al. N Engl J Med. 2022) and ≥3L (ZUMA-1; Neelapu SS, et al. N Engl J Med. 2017) therapy. Additionally, in the Phase 2 ZUMA-12 study in patients with refractory first-line LBCL, axi-cel showed a high rate of durable responses with an objective response rate of 89% (complete response rate, 78%) and an ongoing response rate of 73% (median follow-up, 15.9 months; Neelapu SS, et al. Nat Med. 2022). Aims: ZUMA-23 is the first Phase 3, randomized controlled study to evaluate CAR T-cell therapy as a first-line regimen for any cancer and will assess axi-cel versus SOC in patients with high-risk LBCL, defined as IPI 4-5. Methods: The Phase 3 trial design will enroll approximately 300 adult patients with high-risk, histologically confirmed LBCL based on the 2016 WHO classification, including diffuse large B-cell lymphoma, high-grade B-cell lymphoma, and transformed follicular or marginal zone lymphoma (Swerdlow SH, et al. Blood. 2016). Eligible patients will receive 1 cycle of R-chemotherapy and then be randomized 1:1 to receive axi-cel or continue with SOC. Patients in the axi-cel arm will undergo leukapheresis and then receive R-CHOP or DA-EPOCH-R as bridging therapy, followed by lymphodepleting chemotherapy (fludarabine/cyclophosphamide), and a single axi-cel infusion (2×106 CAR T cells/kg). Prophylactic corticosteroids may be administered to reduce the incidence and severity of cytokine release syndrome at the investigator’s discretion. Patients in the SOC arm will receive 5 additional cycles of R-CHOP or DA-EPOCH-R (investigator’s choice). The primary endpoint is event-free survival by blinded central review. Key secondary endpoints are OS and PFS. Safety, quality of life, and pharmacokinetics will also be assessed. Patients with a history of HIV and/or hepatitis B or C and undetectable viral loads may enroll. Key exclusion criteria include LBCL of the central nervous system. Results: ZUMA-23 is open for enrollment (NCT05605899). Summary/Conclusion: ZUMA-23 will examine the efficacy and safety of axi-cel versus SOC as first-line therapy in patients with high-risk LBCL. Keywords: CD19, High risk, CAR-T, Diffuse large B cell lymphoma" @default.
• W4386087005 created "2023-08-24" @default.
• W4386087005 creator A5000959540 @default.
• W4386087005 creator A5010979808 @default.
• W4386087005 creator A5012489616 @default.
• W4386087005 creator A5016457541 @default.
• W4386087005 creator A5016684714 @default.
• W4386087005 creator A5021496101 @default.
• W4386087005 creator A5022077356 @default.
• W4386087005 creator A5027277177 @default.
• W4386087005 creator A5028012131 @default.
• W4386087005 creator A5035100399 @default.
• W4386087005 creator A5037526878 @default.
• W4386087005 creator A5039235274 @default.
• W4386087005 creator A5046355832 @default.
• W4386087005 creator A5051605599 @default.
• W4386087005 creator A5058757098 @default.
• W4386087005 creator A5069477380 @default.
• W4386087005 creator A5070693731 @default.
• W4386087005 creator A5077430940 @default.
• W4386087005 creator A5084789778 @default.
• W4386087005 creator A5085013906 @default.
• W4386087005 date "2023-08-01" @default.
• W4386087005 modified "2023-10-12" @default.
• W4386087005 title "PB2319: ZUMA-23: A GLOBAL, PHASE 3, RANDOMIZED CONTROLLED STUDY OF AXICABTAGENE CILOLEUCEL VERSUS STANDARD OF CARE AS FIRST-LINE THERAPY IN PATIENTS WITH HIGH-RISK LARGE B-CELL LYMPHOMA" @default.
• W4386087005 doi "https://doi.org/10.1097/01.hs9.0000975996.32786.92" @default.
• W4386087005 hasPublicationYear "2023" @default.
• W4386087005 type Work @default.
• W4386087005 citedByCount "0" @default.
• W4386087005 crossrefType "journal-article" @default.
• W4386087005 hasAuthorship W4386087005A5000959540 @default.
• W4386087005 hasAuthorship W4386087005A5010979808 @default.
• W4386087005 hasAuthorship W4386087005A5012489616 @default.
• W4386087005 hasAuthorship W4386087005A5016457541 @default.
• W4386087005 hasAuthorship W4386087005A5016684714 @default.
• W4386087005 hasAuthorship W4386087005A5021496101 @default.
• W4386087005 hasAuthorship W4386087005A5022077356 @default.
• W4386087005 hasAuthorship W4386087005A5027277177 @default.
• W4386087005 hasAuthorship W4386087005A5028012131 @default.
• W4386087005 hasAuthorship W4386087005A5035100399 @default.
• W4386087005 hasAuthorship W4386087005A5037526878 @default.
• W4386087005 hasAuthorship W4386087005A5039235274 @default.
• W4386087005 hasAuthorship W4386087005A5046355832 @default.
• W4386087005 hasAuthorship W4386087005A5051605599 @default.
• W4386087005 hasAuthorship W4386087005A5058757098 @default.
• W4386087005 hasAuthorship W4386087005A5069477380 @default.
• W4386087005 hasAuthorship W4386087005A5070693731 @default.
• W4386087005 hasAuthorship W4386087005A5077430940 @default.
• W4386087005 hasAuthorship W4386087005A5084789778 @default.
• W4386087005 hasAuthorship W4386087005A5085013906 @default.
• W4386087005 hasBestOaLocation W43860870051 @default.
• W4386087005 hasConcept C121332964 @default.
• W4386087005 hasConcept C126322002 @default.
• W4386087005 hasConcept C142424586 @default.
• W4386087005 hasConcept C143998085 @default.
• W4386087005 hasConcept C2776694085 @default.
• W4386087005 hasConcept C2776755627 @default.
• W4386087005 hasConcept C2777257650 @default.
• W4386087005 hasConcept C2778476033 @default.
• W4386087005 hasConcept C2779338263 @default.
• W4386087005 hasConcept C2779429289 @default.
• W4386087005 hasConcept C2780653079 @default.
• W4386087005 hasConcept C2781214270 @default.
• W4386087005 hasConcept C2781413609 @default.
• W4386087005 hasConcept C71924100 @default.
• W4386087005 hasConcept C87355193 @default.
• W4386087005 hasConceptScore W4386087005C121332964 @default.
• W4386087005 hasConceptScore W4386087005C126322002 @default.
• W4386087005 hasConceptScore W4386087005C142424586 @default.
• W4386087005 hasConceptScore W4386087005C143998085 @default.
• W4386087005 hasConceptScore W4386087005C2776694085 @default.
• W4386087005 hasConceptScore W4386087005C2776755627 @default.
• W4386087005 hasConceptScore W4386087005C2777257650 @default.
• W4386087005 hasConceptScore W4386087005C2778476033 @default.
• W4386087005 hasConceptScore W4386087005C2779338263 @default.
• W4386087005 hasConceptScore W4386087005C2779429289 @default.
• W4386087005 hasConceptScore W4386087005C2780653079 @default.
• W4386087005 hasConceptScore W4386087005C2781214270 @default.
• W4386087005 hasConceptScore W4386087005C2781413609 @default.
• W4386087005 hasConceptScore W4386087005C71924100 @default.
• W4386087005 hasConceptScore W4386087005C87355193 @default.
• W4386087005 hasIssue "S3" @default.
• W4386087005 hasLocation W43860870051 @default.
• W4386087005 hasOpenAccess W4386087005 @default.
• W4386087005 hasPrimaryLocation W43860870051 @default.
• W4386087005 hasRelatedWork W1970186535 @default.
• W4386087005 hasRelatedWork W2006707835 @default.
• W4386087005 hasRelatedWork W2067139305 @default.
• W4386087005 hasRelatedWork W2144434216 @default.
• W4386087005 hasRelatedWork W2144795394 @default.
• W4386087005 hasRelatedWork W2155499847 @default.
• W4386087005 hasRelatedWork W2356363213 @default.
• W4386087005 hasRelatedWork W2361676018 @default.
• W4386087005 hasRelatedWork W2379928158 @default.
• W4386087005 hasRelatedWork W2906751067 @default.
• W4386087005 hasVolume "7" @default.
• W4386087005 isParatext "false" @default.
• W4386087005 isRetracted "false" @default.

• next