title: Should immunoglobulin therapy be used in allogeneic stem-cell transplantation? A randomized, double-blind, dose effect, placebo-controlled, multicenter trial.
abstract: BACKGROUND
  The universal use of prophylactic immunoglobulin in stem-cell transplantation has not been supported by strong evidence of benefit. Results of most trials were reported before effective drugs for cytomegalovirus infection and disease were available, and no trial was placebo controlled.
  
  
  OBJECTIVE
  To assess the role and the dose-effect relationship of immunoglobulin in the prophylaxis of complications after allogeneic stem-cell transplantation.
  
  
  METHODS
  Multicenter randomized, double-blind, dose effect placebo-controlled study.
  
  
  METHODS
  19 stem-cell transplantation centers in France.
  
  
  METHODS
  200 patients who had allogeneic stem-cell transplantation from HLA-identical sibling donors between 1998 and 2000.
  
  
  METHODS
  Immunoglobulin at doses of 50 mg/kg of body weight, 250 mg/kg, or 500 mg/kg weekly from day -7 to day 100 after transplantation or placebo.
  
  
  METHODS
  Cumulative incidence of infection, graft-versus-host disease, veno-occlusive disease, interstitial pneumonia, and transplantation-related mortality at 6 months; overall survival at 2 years after transplantation.
  
  
  RESULTS
  Immunoglobulin had no benefit over placebo; 92% of patients in the pooled immunoglobulin group and 90% of patients in the placebo group had one or more infections (difference, 2 percentage points [95% CI, -8 to 12 percentage points]). Cumulative incidences of interstitial pneumonia, graft-versus-host disease, transplantation-related mortality, and overall survival were similar in patients receiving placebo and those receiving immunoglobulin; no dose-effect relationships were evident. Grade 3 (severe) veno-occlusive disease occurred more frequently as the immunoglobulin dose increased (P = 0.01).
  
  
  CONCLUSIONS
  Use of prophylactic immunoglobulin in allogeneic recipients of stem-cell transplant from HLA-identical sibling donors is not recommended.
authors.affiliation: Assistance Publique-Hôpitaux de Paris, Créteil, France. carlcord@club-internet.fr
authors.forename: Catherine
authors.initials: C
authors.lastname: Cordonnier
authors.forename: Sylvie
authors.initials: S
authors.lastname: Chevret
authors.forename: Marc
authors.initials: M
authors.lastname: Legrand
authors.forename: Homa
authors.initials: H
authors.lastname: Rafi
authors.forename: Nathalie
authors.initials: N
authors.lastname: Dhédin
authors.forename: Blandine
authors.initials: B
authors.lastname: Lehmann
authors.forename: François
authors.initials: F
authors.lastname: Bassompierre
authors.forename: Eliane
authors.initials: E
authors.lastname: Gluckman
mesh_terms: D000328:Adult; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006086:Graft vs Host Disease / Q000517:prevention & control; D006680:HLA Antigens; D018380:Hematopoietic Stem Cell Transplantation / Q000009:adverse effects* / Q000401:mortality; D006504:Hepatic Veno-Occlusive Disease / Q000517:prevention & control; D006648:Histocompatibility; D006801:Humans; D016756:Immunoglobulins, Intravenous / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D017563:Lung Diseases, Interstitial / Q000517:prevention & control; D008297:Male; D010349:Patient Compliance; D010352:Patient Dropouts; D010919:Placebos; D014184:Transplantation, Homologous
chemical_list: D006680:HLA Antigens; D016756:Immunoglobulins, Intravenous; D010919:Placebos