CTOTC-08: A multicenter randomized controlled trial of rituximab induction to reduce antibody development and improve outcomes in pediatric lung transplant recipients

Stuart C. Sweet, Brian Armstrong, Joshua Blatter, Hyunsook Chin, Carol Conrad, Samuel Goldfarb, Don Hayes, Peter S. Heeger, Victoria Lyou, Ernestina Melicoff-Portillo, Thalachallour Mohanakumar, Jonah Odim, Ranjithkumar Ravichandran, Marc Schecter, Gregory A. Storch, Gary Visner, Nikki M. Williams, Lara Danziger-Isakov

Research output: Contribution to journalArticlepeer-review

2 Scopus citations

Abstract

We conducted a randomized, placebo-controlled, double-blind study of pediatric lung transplant recipients, hypothesizing that rituximab plus rabbit anti-thymocyte globulin induction would reduce de novo donor-specific human leukocyte antigen antibodies (DSA) development and improve outcomes. We serially obtained clinical data, blood, and respiratory samples for at least one year posttransplant. We analyzed peripheral blood lymphocytes by flow cytometry, serum for antibody development, and respiratory samples for viral infections using multiplex PCR. Of 45 subjects enrolled, 34 were transplanted and 27 randomized to rituximab (n = 15) or placebo (n = 12). No rituximab-treated subjects versus five placebo-treated subjects developed de novo DSA with mean fluorescence intensity >2000. There was no difference between treatment groups in time to the primary composite outcome endpoint (death, bronchiolitis obliterans syndrome [BOS] grade 0-p, obliterative bronchiolitis or listing for retransplant). A post-hoc analysis substituting more stringent chronic lung allograft dysfunction criteria for BOS 0-p showed no difference in outcome (p =.118). The incidence of adverse events including infection and rejection episodes was no different between treatment groups. Although the study was underpowered, we conclude that rituximab induction may have prevented early DSA development in pediatric lung transplant recipients without adverse effects and may improve outcomes (Clinical Trials: NCT02266888).

Original languageEnglish
Pages (from-to)230-244
Number of pages15
JournalAmerican Journal of Transplantation
Volume22
Issue number1
DOIs
StatePublished - Jan 2022

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