A phase II multicenter study of visilizumab, humanized anti-CD3 antibody, to treat steroid-refractory acute graft-versus-host disease

Biology of Blood and Marrow Transplantation

Volumn 11, Issue 6, 2005, Pages 465-471

  Carpenter, Paul A ^a,b   Lowder, James ^c   Johnston, Laura ^d   Frangoul, Haydar ^e   Khoury, Hanna ^f   Parker, Pablo ^g   Jerome, Keith R ^a,b   McCune, Jeannine S ^a,b   Storer, Barry ^a,b   Martin, Paul ^a,b   Appelbaum, Frederick ^a,b   Abonour, Rafat ^h   Westervelt, Peter ⁱ   Anasetti, Claudio ^j  

^a Fred Hutchinson Cancer Research Center   (United States)

^b UNIVERSITY OF WASHINGTON   (United States)

^c PROTEIN DESIGN LABS INC   (United States)

^d STANFORD UNIVERSITY   (United States)

^e VANDERBILT UNIVERSITY   (United States)

^f WASHINGTON UNIVERSITY   (United States)

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

^h INDIANA UNIVERSITY SCHOOL OF MEDICINE   (United States)

ⁱ UNIVERSITY OF MASSACHUSETTS MEDICAL SCHOOL   (United States)

^j H LEE MOFFITT CANCER CENTER AND RESEARCH INSTITUTE   (United States)

more..

Author keywords

Anti CD3; Graft versus host disease; Hematopoietic cell transplantation; Monoclonal antibody; Steroid refractory; Visilizumab

Indexed keywords

CALCINEURIN INHIBITOR; CYCLOSPORIN; METHOTREXATE; METHYLPREDNISOLONE; MYCOPHENOLIC ACID 2 MORPHOLINOETHYL ESTER; RITUXIMAB; STEROID; TACROLIMUS; VIRUS DNA; VISILIZUMAB;

ACUTE GRAFT VERSUS HOST DISEASE; ADOLESCENT; ADULT; AGED; ARTICLE; CHILD; CHILL; CLINICAL ARTICLE; CLINICAL TRIAL; CONFIDENCE INTERVAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DEATH; DIGESTIVE SYSTEM DISEASE; DISEASE SEVERITY; DRUG BLOOD LEVEL; DRUG EFFICACY; DRUG FATALITY; DRUG FEVER; DRUG HALF LIFE; DRUG HYPERSENSITIVITY; DRUG SAFETY; ENCEPHALITIS; EPSTEIN BARR VIRUS; FEMALE; GRAFT SURVIVAL; HUMAN; HYPOTENSION; KAPLAN MEIER METHOD; MALE; MULTICENTER STUDY; MYCOSIS; PAIN; PHASE 2 CLINICAL TRIAL; TACHYCARDIA; TREATMENT FAILURE;

ACUTE DISEASE; ADOLESCENT; ADULT; AGED; ANTIBODIES, MONOCLONAL; CHILD; CHILD, PRESCHOOL; FEMALE; GRAFT VS HOST DISEASE; HEMATOLOGIC NEOPLASMS; HEMATOPOIETIC STEM CELL TRANSPLANTATION; HUMANS; MALE; MIDDLE AGED; STEROIDS; SURVIVAL ANALYSIS;

EID: 19944415907     PISSN: 10838791     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.bbmt.2005.03.002     Document Type: Article

References (24)

1. P.J. Martin B.J. Nelson F.R. Appelbaum et al. Evaluation of a CD5-specific immunotoxin for treatment of acute graft-versus-host disease after allogeneic marrow transplantation Blood 88 1996 824-830
2. S.J. Lee D. Zahrieh E. Agura et al.Effect of up-front daclizumab when combined with steroids for the treatment of acute graft versus host disease: Results of a randomized trial Blood 104 2004 1559-1564
3. M. Remberger J. Aschan L. Barkholt J. Tolleman O. Ringden Treatment of severe acute graft-versus-host disease with anti-thymocyte globulin Clin Transplant 15 2001 147-153
4. L.K. McCaul T.J. Nevill M.J. Barnett et al. Treatment of steroid-resistant acute graft-versus-host disease with rabbit antithymocyte globulin J Hematother Stem Cell Res 9 2000 367-374
5. H. Khoury A. Kashyap D.R. Adkins et al. Treatment of steroid-resistant acute graft-versus-host disease with antithymocyte globulin Bone Marrow Transplant 27 2001 1059-1064
6. S. Durrant P. Mollee A.J. Morton et al. Combination therapy with tacrolimus and antithymocyte globulin for the treatment of steroid-resistant acute graft-versus-host disease developing during cyclosporine prophylaxis Br J Haematol 113 2001 217-223
7. M. Cole C. Anasetti J.Y. Tso Human IgG2 variants of chimeric anti-CD3 are non-mitogenic to T cells J Immunol 159 1997 3613-3621
8. M.S. Cole K.W. Stellrecht J.D. Shi et al. HuM291, a humanized anti-CD3 antibody, is immunosuppressive to T cells while exhibiting reduced mitogenicity in vitro Transplantation 68 1999 563-571
9. P.A. Carpenter S. Pavlovic J.Y. Tso et al. Non-Fc receptor-binding humanized anti-CD3 antibodies induce apoptosis of activated human T cells J Immunol 165 2000 6205-6213
10. P.A. Carpenter F.R. Appelbaum L. Corey et al. A humanized non-FcR-binding anti-CD3 antibody, visilizumab, for treatment of steroid-refractory acute graft-versus-host disease Blood 99 2002 2712-2719
11. M.F. Folstein S.E. Folstein P.R. McHugh Mini-Mental State: A practical method for grading the state of patients for the clinician J Psychiatr Res 12 1975 189-198
12. R.M. Crum J.C. Anthony S.S. Bassett M.F. Folstein Population-based norms for the Mini-Mental State Examination by age and educational level JAMA 18 1993 2386-2391
13. H. Glucksberg R. Storb A. Fefer et al. Clinical manifestations of graft-versus-host disease in human recipients of marrow from HLA-matched sibling donors Transplantation 18 1974 295-304
14. P. Ljungman F.Z. Wang D.A. Clark et al. High levels of human herpesvirus DNA in peripheral blood leucocytes are correlated to platelet engraftment and disease in allogeneic stem cell transplant patients Br J Haematol 111 2000 774-781
15. D.M. Zerr L. Corey H.W. Kim M.-L. Huang L. Nguy M. Boeckh Clinical outcomes of human herpesvirus 6 reactivation after hematopoietic stem cell transplantation Clin Infect Dis 40 2005 932-940
16. J.D. Meyers P. Lungman L.D. Fisher Cytomegalovirus excretion as a predictor of cytomegalovirus disease after marrow transplantation: Importance of cytomegalovirus viremia J Infect Dis 162 1990 373-380
17. R.E. Curtis L.B. Travis P.A. Rowlings et al. Risk of lymphoproliferative disorders after bone marrow transplantation: A multi-institutional study Blood 94 1999 2208-2216
18. H.-J. Wagner Y.C. Cheng M.H. Huls et al. Prompt versus pre-emptive intervention for EBV lymphoproliferative disease Blood 103 2004 3979-3981
19. T.G. Gross M. Steinbuch T. DeFor et al. B cell lymphoproliferative disorders following hematopoietic stem cell transplantation: Risk factors, treatment and outcome Bone Marrow Transplant 23 1999 251-258
20. I.N.M. Micallef M. Chhanabhai R.D. Gascoyne et al. Lymphoproliferative disorders following allogeneic bone marrow transplantation: The Vancouver experience Bone Marrow Transplant 22 1998 981-987
21. J.W.J. Van Esser H.G.M. Niesters B. Van der Holt et al.Prevention of Epstein-Barr virus-lymphoproliferative disease by molecular monitoring and preemptive rituximab in high-risk patients after allogeneic stem cell transplantation Blood 99 2002 4363-4369
22. D. Przepiorka N.A. Kernan C. Ippoliti et al. Daclizumab, a humanized anti-interleukin-2 receptor alpha chain antibody, for treatment of acute graft-versus-host disease Blood 95 2000 83-89
23. D. Couriel R. Saliba K. Hicks et al. Tumor necrosis factor-alpha blockade for the treatment of acute GVHD Blood 104 2004 649-654
24. V.T. Ho D. Zahrieh E. Hochberg et al.Safety and efficacy of denileukin diftitox in patients with steroid-refractory acute graft-versus-host disease after allogeneic stem cell transplantation Blood 104 2004 1224-1226