Maertens, Johan and Logan, Aaron C. and Jang, Junho and Long, Gwynn and Tang, Jih-Luh and Hwang, William Y. K. and Koh, Liang Piu and Chemaly, Roy and Gerbitz, Armin and Winkler, Julia and Yeh, Su-Peng and Hiemenz, John and Christoph, Sandra and Lee, Dong-Gun and Wang, Po-Nan and Holler, Ernst and Mielke, Stephan and Akard, Luke and Yeo, Adeline and Ramachandra, Sangana and Smith, Kristin and Pertel, Peter and Segal, Florencia (2020) Phase 2 Study of Anti-Human Cytomegalovirus Monoclonal Antibodies for Prophylaxis in Hematopoietic Cell Transplantation. ANTIMICROBIAL AGENTS AND CHEMOTHERAPY, 64 (4): e02467-19. ISSN 0066-4804, 1098-6596
Full text not available from this repository. (Request a copy)Abstract
Human 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 (UP538 and UP539) 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.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | VERSUS-HOST-DISEASE; RISK-FACTORS; LETERMOVIR; INFECTION; DONOR; hematopoietic stem cell transplantation; human cytomegalovirus; prophylaxis |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Innere Medizin III (Hämatologie und Internistische Onkologie) |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 29 Mar 2021 08:09 |
| Last Modified: | 29 Mar 2021 08:09 |
| URI: | https://pred.uni-regensburg.de/id/eprint/44863 |
Actions (login required)
 |
View Item |
