Randomized, placebo-controlled, double-blind study of a cytomegalovirus-specific monoclonal antibody (MSL-109) for prevention of cytomegalovirus infection after allogeneic hematopoietic stem cell transplantation

Biology of Blood and Marrow Transplantation

Volumn 7, Issue 6, 2001, Pages 343-351

  Boeckh, Michael ^a,e   Bowden, Raleigh ^a,e   Storer, Barry ^a,e   Chao, Nelson ^b   Spielberger, Ricardo ^c   Tierney, D Kathryn ^b   Gallez Hawkins, Ghislaine ^c   Cunningham, Terri ^a,e   Blume, Karl ^b   Levitt, Daniel ^d   Zaia, John ^c  

^a Fred Hutchinson Cancer Research Center   (United States)

^b UNIVERSITY OF WASHINGTON   (United States)

^c STANFORD UNIVERSITY   (United States)

^d CITY OF HOPE NATIONAL MEDICAL CENTER   (United States)

^e PROTEIN DESIGN LABS INC   (United States)

Author keywords

Cytomegalovirus; MSL 109; pp65 antigenemia; Stem cell transplantation

Indexed keywords

FOSCARNET; GANCICLOVIR; IMMUNOGLOBULIN G1; MONOCLONAL ANTIBODY; PLACEBO; SEVIRUMAB; VIRUS ANTIGEN; VIRUS DNA; VIRUS GLYCOPROTEIN; VIRUS PROTEIN;

ADULT; ALLOGRAFT; ARTICLE; BACTERIAL INFECTION; CHEMOPROPHYLAXIS; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CYTOMEGALOVIRUS INFECTION; DONOR; DOSE TIME EFFECT RELATION; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG TOLERABILITY; FEMALE; FOLLOW UP; GRAFT VERSUS HOST REACTION; HEMATOPOIETIC STEM CELL TRANSPLANTATION; HOSPITALIZATION; HUMAN; IMMUNE RESPONSE; MAJOR CLINICAL STUDY; MALE; MORTALITY; MULTICENTER STUDY; MYCOSIS; NEUTROPHIL; RANDOMIZED CONTROLLED TRIAL; RECIPIENT; SEROLOGY; SIDE EFFECT; STATISTICAL ANALYSIS; SURVIVAL RATE; THROMBOCYTE; VIREMIA; VIRUS CULTURE;

EID: 0034925349     PISSN: 10838791     EISSN: None     Source Type: Journal    
DOI: 10.1016/S1083-8791(01)80005-7     Document Type: Article

References (39)

1. Cytomegalovirus infection after BMT
2. Polymerase chain reaction monitoring reduces the incidence of cytomegalovirus disease and the duration and side effects of antiviral therapy after bone marrow transplantation
3. Cytomegalovirus pp65 antigenemia-guided early treatment with ganciclovir versus ganciclovir at engraftment after allogeneic marrow transplantation: A randomized double-blind study
4. Bone marrow transplants from unrelated donors for patients with chronic myeloid leukemia
5. Early treatment with ganciclovir to prevent cytomegalovirus disease after allogeneic bone marrow transplantation
6. Neutropenia in allogeneic marrow transplant recipients receiving ganciclovir for prevention of CMV disease: Risk factors and outcome
7. Recovery of HLA-restricted cytomegalovirus (CMV)-specific T-cell responses after allogeneic bone marrow transplant: Correlation with CMV disease and effect of ganciclovir prophylaxis
8. Increased incidence of late CMV disease in allogeneic marrow transplant recipients after ganciclovir prophylaxis is due to a lack of CMV-specific T cell responses
9. Prevention of cytomegalovirus infection by cytomegalovirus immune globulin after marrow transplantation
10. Cytomegalovirus (CMV)-specific intravenous immunoglobulin for the prevention of primary CMV infection and disease after marrow transplant
11. Human cytomegalovirus glycoproteins
12. In vitro neutralization of cytomegalovirus strain by a human monoclonal antibody, MSL-109
13. Human monoclonal anti-cytomegalovirus (CMV) antibody (MSL 109): Enhancement of in vitro foscarnet- and ganciclovir-induced inhibition of CMV replication
14. Phase I study of safety and pharmacokinetics of a human anticytomegalovirus monoclonal antibody in allogeneic bone marrow transplant recipients
15. Human monoclonal antibodies neutralizing cytomegalovirus (CMV) for prophylaxis of CMV disease: Report of a phase I trial in bone marrow transplant recipients
16. AIDS Clinical Trials Group. MSL-109 adjuvant therapy for cytomegalovirus retinitis in patients with acquired immunodeficiency syndrome: The Monoclonal Antibody Cytomegalovirus Retinitis Trial
17. Cytomegalovirus pneumonia after bone marrow transplantation successfully treated with the combination of ganciclovir and high-dose intravenous immune globulin
18. Ganciclovir/immunoglobulin combination therapy for the treatment of human cytomegalovirus-associated interstitial pneumonia in bone marrow allograft recipients
19. Treatment of cytomegalovirus pneumonia with ganciclovir and intravenous cytomegalovirus immunoglobulin in patients with bone marrow transplants
20. Cytomegalovirus immune globulin prophylaxis in liver transplantation. A randomized, double-blind, placebo-controlled trial
21. Results of different strategies for reducing cytomegalovirus-associated mortality in allogeneic stem cell transplant recipients
22. Evaluation of CMV Brite kit for detection of cytomegalovirus pp65 antigenemia in peripheral blood leukocytes by immunofluorescence
23. Preemptive ganciclovir administration based solely on asymptomatic pulmonary cytomegalovirus infection in allogeneic bone marrow transplant recipients: Long-term follow-up
24. Evaluation of a quantitative plasma PCR plate assay for detecting cytomegalovirus infection in marrow transplant recipients
25. 1994 Consensus Conference on Acute GVHD Grading
26. Chronic graft-versus-host syndrome in man. A long-term clinicopathologic study of 20 Seattle patients
27. Cyclosporine or cyclosporine plus methylprednisolone for prophylaxis of graft-versus-host disease: A prospective, randomized trial
28. Increased risk of infection in marrow transplant patients receiving methyl-prednisolone for graft-versus-host disease prevention
29. Pathogenesis of cytomegalovirus pneumonia in immunocompromised hosts
30. Cytotoxic T-lymphocyte response to cytomegalovirus after human allogeneic bone marrow transplantation: Pattern of recovery and correlation with cytomegalovirus infection and disease
31. The humoral immune response against human cytomegalovirus is characterized by a delayed synthesis of glycoprotein-specific antibodies
32. Kinetics of the antibody response against human cytomegalovirus-specific proteins in allogeneic bone marrow transplant recipients
33. Strain-specific neutralization of human cytomegalovirus isolates by human sera
34. The protective effects of hyperimmune anti-murine cytomegalovirus antiserum against lethal viral challenge: The case for passive-active immunization
35. Palivizumab, a humanized respiratory syncytial virus monoclonal antibody, reduces hospitalization from respiratory syncytial virus infection in high-risk infants
36. Valacyclovir for the prevention of cytomegalovirus disease after renal transplantation
37. Impact of prophylactic immediate posttransplant ganciclovir on development of transplant atherosclerosis: A post hoc analysis of a randomized, placebo-controlled study