Immunoglobulin prophylaxis prevents hospital admissions for fever in pediatric acute lymphoblastic leukemia: results of a multicenter randomized trial
Kirsten A. Thus,
Hester A. de Groot-Kruseman,
Pauline Winkler-Seinstra,
Marta Fiocco,
Heidi Segers,
Cor van den Bos,
Inge M. van der Sluis,
Wim J.E. Tissing,
Margreet A. Veening,
Christian Michel Zwaan,
Cornelis M. van Tilburg,
Rob Pieters,
Marc Bierings
Affiliations
Kirsten A. Thus
Princess Máxima Center for Pediatric Oncology, Utrecht
Hester A. de Groot-Kruseman
Princess Máxima Center for Pediatric Oncology, Utrecht
Pauline Winkler-Seinstra
Princess Máxima Center for Pediatric Oncology, Utrecht
Marta Fiocco
Mathematical Institute Leiden University, Leiden University, Leiden, The Netherlands; Department of Biomedical Data Science, Section Medical Statistics, Leiden University Medical Center, Leiden, The Netherlands; Princess Máxima Center for Pediatric Oncology, Utrecht
Heidi Segers
Department of Pediatric Hemato-Oncology, University Hospitals Leuven, Leuven, Belgium
Cor van den Bos
Department of Pediatric Oncology, Emma Children’s Hospital, Amsterdam UMC, Amsterdam, the Netherlands; Princess Máxima Center for Pediatric Oncology, Utrecht
Inge M. van der Sluis
Department of Pediatric Oncology, Erasmus MC-Sophia Children’s Hospital, Rotterdam, the Netherlands; Princess Máxima Center for Pediatric Oncology, Utrecht
Wim J.E. Tissing
Department of Pediatric Oncology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands; Princess Máxima Center for Pediatric Oncology, Utrecht
Margreet A. Veening
Emma Children's Hospital, Amsterdam UMC, Vrije Universiteit Amsterdam, Pediatric Oncology, Cancer Center Amsterdam, Amsterdam, The Netherlands; Princess Máxima Center for Pediatric Oncology, Utrecht
Christian Michel Zwaan
Department of Pediatric Oncology, Erasmus MC-Sophia Children’s Hospital, Rotterdam, the Netherlands; Princess Máxima Center for Pediatric Oncology, Utrecht
Cornelis M. van Tilburg
Hopp Children’s Cancer Center Heidelberg (KiTZ), Heidelberg, Germany; Clinical Cooperation Unit Pediatric Oncology, German Cancer Research Center (DKFZ), Heidelberg, Germany; Department of Pediatric Oncology, Hematology, Immunology and Pulmonology, Heidelberg University Hospital, Heidelberg, Germany; German Cancer Consortium (DKTK), Heidelberg, Germany; National Center for Tumor diseases (NCT), Heidelberg
Rob Pieters
Princess Máxima Center for Pediatric Oncology, Utrecht
Marc Bierings
Princess Máxima Center for Pediatric Oncology, Utrecht
Infections lead to substantial morbidity during treatment of acute lymphoblastic leukemia (ALL) in which the adaptive immune system gets severely affected, leading to declining serum immunoglobulin levels. The aim of this trial was to investigate whether intravenous immunoglobulin (IVIG) prophylaxis in pediatric patients with ALL prevents admissions for fever. This randomized controlled trial was a subtrial of the national Dutch multicenter ALL study. Patients aged 1-19 years with medium risk (MR) ALL were randomized into two groups receiving either IVIG prophylaxis (0.7 g/kg IVIG given every three weeks, starting day 22 after diagnosis) or well defined standard of care (control group). Between October 2012 until March 2019, 91 (51%) patients were randomly assigned to IVIG prophylaxis and 86 (49%) to the control arm. In the IVIG prophylaxis group there were 206 admissions for fever versus 271 in the control group (p=0.011). IVIG prophylaxis was not associated with bacteremia. However, IVIG prophylaxis was associated with significantly less admissions for fever with negative blood cultures compared to the control group (N=113 versus 200, p
