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dc.titlePhase 2 study of anti-human cytomegalovirus monoclonal antibodies for prophylaxis in hematopoietic cell transplantation
dc.contributor.authorMaertens, J
dc.contributor.authorLogan, AC
dc.contributor.authorJang, J
dc.contributor.authorLong, G
dc.contributor.authorTang, JL
dc.contributor.authorHwang, WYK
dc.contributor.authorKoh, LP
dc.contributor.authorChemaly, R
dc.contributor.authorGerbitz, A
dc.contributor.authorWinkler, J
dc.contributor.authorYeh, SP
dc.contributor.authorHiemenz, J
dc.contributor.authorChristoph, S
dc.contributor.authorLee, DG
dc.contributor.authorWang, PN
dc.contributor.authorHoller, E
dc.contributor.authorMielke, S
dc.contributor.authorAkard, L
dc.contributor.authorYeo, A
dc.contributor.authorRamachandra, S
dc.contributor.authorSmith, K
dc.contributor.authorPertel, P
dc.contributor.authorSegal, F
dc.identifier.citationMaertens, J, Logan, AC, Jang, J, Long, G, Tang, JL, Hwang, WYK, Koh, LP, Chemaly, R, Gerbitz, A, Winkler, J, Yeh, SP, Hiemenz, J, Christoph, S, Lee, DG, Wang, PN, Holler, E, Mielke, S, Akard, L, Yeo, A, Ramachandra, S, Smith, K, Pertel, P, Segal, F (2020-01-01). Phase 2 study of anti-human cytomegalovirus monoclonal antibodies for prophylaxis in hematopoietic cell transplantation. Antimicrobial Agents and Chemotherapy 64 (4) : e02467-e02419. ScholarBank@NUS Repository.
dc.description.abstractHuman cytomegalovirus (HCMV) can cause significant disease in immunocompromised patients, and treatment options are limited by toxicities. CSJ148 is a combination of two anti-HCMV human monoclonal antibodies (LJP538 and LJP539) that bind to and inhibit the functions of viral HCMV glycoprotein B (gB) and the pentameric complex, consisting of glycoproteins gH, gL, UL128, UL130, and UL131. In this phase 2, randomized, placebo-controlled trial, we evaluated the safety and efficacy of CSJ148 for prophylaxis of HCMV in patients undergoing allogeneic hematopoietic stem cell transplantation. As would be expected in the study population, all the patients (100%) reported at least one treatment-emergent adverse event. There were 22 deaths during this study, and over 80% of the patients receiving placebo or CSJ148 developed at least one adverse event of grade 3 or higher severity. No subject who received antibody developed a hypersensitivity- or infusion-related reaction. CSJ148-treated patients showed trends toward decreased viral load, shorter median duration of preemptive therapy, and fewer courses of preemptive therapy. However, the estimated probability that CSJ148 decreases the need for preemptive therapy compared to placebo was 69%, with a risk ratio of 0.89 and a 90% credible interval of 0.61 to 1.31. The primary efficacy endpoint was therefore not met, indicating that CSJ148 did not prevent clinically significant HCMV reactivation in recipients of allogeneic hematopoietic cell transplants.
dc.publisherAmerican Society for Microbiology
dc.subjecthematopoietic stem cell transplantation
dc.subjecthuman cytomegalovirus
dc.subjectAdministration, Intravenous
dc.subjectAntibodies, Viral
dc.subjectAntiviral Agents
dc.subjectCytomegalovirus Infections
dc.subjectGraft vs Host Disease
dc.subjectHematopoietic Stem Cell Transplantation
dc.subjectMiddle Aged
dc.subjectTreatment Outcome
dc.subjectViral Load
dc.subjectYoung Adult
dc.contributor.departmentDUKE-NUS MEDICAL SCHOOL
dc.description.sourcetitleAntimicrobial Agents and Chemotherapy
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