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Should Immunoglobulin Therapy Be Used in Allogeneic Stem-Cell Transplantation?: A Randomized, Double-Blind, Dose Effect, Placebo-Controlled, Multicenter Trial

Catherine Cordonnier, MD, PhD; Sylvie Chevret, MD, PhD; Marc Legrand; Homa Rafi, MD; Nathalie Dhédin, MD; Blandine Lehmann, PharmD; François Bassompierre, MD; Eliane Gluckman, MD, PhD, GREFIG Study Group*
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From Assistance Publique-Hôpitaux de Paris, Créteil, France.


The authors dedicate this article to Claude Chastang, MD, PhD, a friend and colleague whose vision and leadership have been cornerstones in the design and development of therapeutic trials in France. He played a major role in the design of this study. His friendship will be missed.

Acknowledgment: The authors thank the physicians, pharmacists, data managers, and nurses of the participating centers and the support staff of the Délégation de la Recherche Clinique, Hôpital Saint-Louis, Paris. The authors also thank Dr. Isabel Cunningham for her critical reading of the manuscript and Dr. Per Ljungman for his useful comments.

Grant Support: By the French Ministry of Health (PHRC 96029), Assistance Publique-Hôpitaux de Paris (GERMED 1996), and the Caisse Nationale d'Assurance Maladies des Professions Indépendantes.

Potential Financial Conflicts of Interest: None disclosed.

Requests for Single Reprints: Catherine Cordonnier, MD, Service d'Hématologie Clinique, Hôpital Henri Mondor, 51, Av. Maréchal de Lattre de Tassigny, 94000 Créteil, France; e-mail, carlcord@club-internet.fr.

Current Author Addresses: Drs. Cordonnier and Rafi: Service d'Hématologie Clinique, Hôpital Henri Mondor, 51, Av. Maréchal de Lattre de Tassigny, 94000 Créteil, France.

Dr. Chevret: Département de Biostatistique et Informatique Médicale, Hôpital Saint-Louis, 1, Avenue Claude Vellefaux, 75475 Paris Cedex 10, France.

Mr. Legrand: Département d'Information Médicale, Hôpital Robert Debré, 49, Boulevard Serurier, 75019 Paris, France.

Dr. Dhédin: Service d'Hématologie, Hôpital Pitié-Salpétriêre, 47-83, Boulevard de l'hôpital, 75013 Paris, France.

Dr. Lehmann: Unité Essais Cliniques, Etablissement Pharmaceutique des Hôpitaux de Paris, 7, rue du Fer à Moulin, 75005 Paris, France.

Dr. Bassompierre: Délégation Régionale à la Recherche Clinique, Hôpital Saint-Louis Aile Hillairet, 1, Avenue Claude Vellefaux, 75475 Paris Cedex 10, France.

Dr. Glückman: Unité de Greffe de Moelle, Hôpital Saint-Louis, 1, Avenue Claude Vellefaux, 75475 Paris Cedex 10, France.

Author Contributions: Conception and design: C. Cordonnier, F. Bassompierre, E. Gluckman.

Analysis and interpretation of the data: C. Cordonnier, S. Chevret.

Drafting of the article: C. Cordonnier.

Critical revision of the article for important intellectual content: H. Rafi, B. Lehmann.

Final approval of the article: C. Cordonnier, S. Chevret, E. Gluckman.

Provision of study materials or patients: C. Cordonnier, H. Rafi, N. Dhédin, B. Lehmann.

Statistical expertise: S. Chevret.

Obtaining of funding: C. Cordonnier, F. Bassompierre, E. Gluckman.

Administrative, technical, or logistic support: M. Legrand, H. Rafi, B. Lehmann, F. Bassompierre.

Collection and assembly of data: M. Legrand.


Ann Intern Med. 2003;139(1):8-18. doi:10.7326/0003-4819-139-1-200307010-00007
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We sought to demonstrate the benefit of using immunoglobulin to prevent infections in geno-identical transplant recipients. We hypothesized that there may be a relationship between dose of immunoglobulin and effect. Our findings did not show that immunoglobulin had any substantive benefit over placebo in preventing infection; the 95% CI of the difference in cumulative incidences of infected patients between the pooled immunoglobulin groups and the placebo group was −8% to 12%. In other words, the data are statistically compatible with both an 8% advantage and a 12% disadvantage for the pooled immunoglobulin groups in preventing infection; a true difference near or at those extremes is comparatively unlikely. Nevertheless, this 12% disadvantage for the immunoglobulin group did not seem to be clinically relevant. Thus, this result suggests the clinical equivalence for the primary end point, although this was not specified before data analysis. Otherwise, we found no difference in incidences of interstitial pneumonia and acute or chronic graft-versus-host disease. Moreover, no dose-effect relationships for immunoglobulin were observed, with one exception: Severe veno-occlusive disease occurred more frequently when the immunoglobulin dose was increased. Finally, transplantation-related mortality at 6 months and overall survival at 24 months after transplantation were similar among groups.

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Figures

Grahic Jump Location
Figure 1.
Flow diagram of the trial.

IVIG = intravenous immunoglobulin.

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Grahic Jump Location
Figure 2.
Estimated overall survival in the placebo and pooled immunoglobulin groups.

The administration of immunoglobulin did not statistically affect the overall survival.

Grahic Jump Location

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Summary for Patients

Immunoglobulin in Patients with Stem-Cell Transplants

The summary below is from the full report titled “Should Immunoglobulin Therapy Be Used in Allogeneic Stem-Cell Transplantation? A Randomized, Double-Blind, Dose Effect, Placebo-Controlled, Multicenter Trial.” It is in the 1 July 2003 issue of Annals of Internal Medicine (volume 139, pages 8-18). The authors are C. Cordonnier, S. Chevret, M. Legrand, H. Rafi, N. Dhédin, B. Lehmann, F. Bassompierre, and E. Gluckman, for the GREFIG Study Group.

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