Controlled, randomized, open-label trial of risk-stratified corticosteroid prevention of acute graft-versus-host disease after haploidentical transplantation

Journal of Clinical Oncology

Volumn 34, Issue 16, 2016, Pages 1855-1863

  Chang, Ying Jun ^a,c   Xu, Lan Ping ^a   Wang, Yu ^a   Zhang, Xiao Hui ^a   Chen, Huan ^a   Chen, Yu Hong ^a   Wang, Feng Rong ^a   Han, Wei ^a   Sun, Yu Qian ^a   Yan, Chen Hua ^a   Tang, Fei Fei ^a   Mo, Xiao Dong ^a   Liu, Kai Yan ^a   Huang, Xiao Jun ^a,b,c  

^a PEKING UNIVERSITY PEOPLE S HOSPITAL   (China)

^b Tsinghua University   (China)

^c PEKING UNIVERSITY   (China)

Author keywords

[No Author keywords available]

Indexed keywords

BASILIXIMAB; CYCLOSPORIN; GLUCOCORTICOID; METHOTREXATE; MYCOPHENOLATE MOFETIL; CORTICOSTEROID;

ACUTE GRAFT VERSUS HOST DISEASE; ADOLESCENT; ADULT; ALLOGENEIC STEM CELL TRANSPLANTATION; ALLOGRAFT; BONE MARROW TRANSPLANTATION; CD4 CD8 RATIO; CHRONIC GRAFT VERSUS HOST DISEASE; CONFERENCE PAPER; CONTROLLED STUDY; CORTICOSTEROID THERAPY; DRUG DOSE REDUCTION; FEMALE; FEMUR HEAD NECROSIS; GRAFT SURVIVAL; HAPLOIDENTICAL TRANSPLANTATION; HUMAN; HYPERTENSION; INCIDENCE; INFECTION RATE; LOW DRUG DOSE; MAJOR CLINICAL STUDY; MALE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; THROMBOCYTE; ACUTE DISEASE; ADVERSE EFFECTS; ALLOTRANSPLANTATION; GRAFT VS HOST DISEASE; HEMATOPOIESIS; MIDDLE AGED;

ACUTE DISEASE; ADOLESCENT; ADRENAL CORTEX HORMONES; ADULT; BONE MARROW TRANSPLANTATION; FEMALE; GRAFT VS HOST DISEASE; HEMATOPOIESIS; HUMANS; MALE; MIDDLE AGED; TRANSPLANTATION, HOMOLOGOUS;

EID: 84973103722     PISSN: 0732183X     EISSN: 15277755     Source Type: Journal    
DOI: 10.1200/JCO.2015.63.8817     Document Type: Conference Paper

References (43)

1. Guinan EC, Boussiotis VA, Neuberg D, et al: Transplantation of anergic histoincompatible bone marrow allografts. N Engl J Med 340:1704-1714, 1999
2. Ferrara JL, Levine JE, Reddy P, et al: Graftversus-host disease. Lancet 373:1550-1561, 2009
3. Anasetti C, Logan BR, Lee SJ, et al: Peripheralblood stem cells versus bone marrow from unrelated donors. N Engl J Med 367:1487-1496, 2012
4. Chang YJ, Huang XJ: Haploidentical hematopoietic stem cell transplantation with unmanipulated granulocyte colony stimulating factor mobilized marrow and blood grafts. Curr Opin Hematol 19: 454-461, 2012
5. Wang Y, Chang YJ, Xu LP, et al: Who is the best donor for a related HLA haplotype-mismatched transplant? Blood 124:843-850, 2014
6. Di Bartolomeo P, Santarone S, De Angelis G, et al: Haploidentical, unmanipulated, G-CSF-primed bone marrow transplantation for patients with highrisk hematologic malignancies. Blood 121:849-857, 2013
7. Quellmann S, Schwarzer G, Hübel K, et al: Corticosteroids in the prevention of graft-vs-host disease after allogeneic myeloablative stem cell transplantation: A systematic review and metaanalysis. Leukemia 22:1801-1803, 2008
8. Chao NJ, Snyder DS, Jain M, et al: Equivalence of 2 effective graft-versus-host disease prophylaxis regimens: Results of a prospective double-blind randomized trial. Biol Blood Marrow Transplant 6:254-261, 2000
9. Ruutu T, Volin L, Parkkali T, et al: Cyclosporine, methotrexate, and methylprednisolone compared with cyclosporine and methotrexate for the prevention of graft-versus-host disease in bone marrow transplantation from HLA-identical sibling donor: A prospective randomized study. Blood 96:2391-2398, 2000
10. Deeg HJ, Lin D, Leisenring W, et al: Cyclosporine or cyclosporine plus methylprednisolone for prophylaxis of graft-versus-host disease: A prospective, randomized trial. Blood 89:3880-3887, 1997
11. Deeg HJ, Flowers ME, Leisenring W, et al: Cyclosporine (CSP)or CSP plus methylprednisolone for graft-versus-host disease prophylaxis in patients with high-risk lymphohemopoietic malignancies: long-term follow-up of a randomized trial. Blood 96: 1194-1195, 2000
12. Atkinson K, Biggs J, Concannon A, et al: A prospective randomised trial of cyclosporin and methotrexate versus cyclosporin, methotrexate and prednisolone for prevention of graft-versus-host disease after HLA-identical sibling marrow transplantation for haematological malignancy. Aust N Z J Med 21:850-856, 1991
13. Storb R, Pepe M, Anasetti C, et al: What role for prednisone in prevention of acute graft-versushost disease in patients undergoing marrow transplants? Blood 76:1037-1045, 1990
14. Wang Y, Xu LP, Liu KY, et al: Low-dose MTX combined with low-dose methylprednisolone as a first-line therapy for the treatment of acute GVHD: safety and feasibility. Bone Marrow Transplant 46: 892-898, 2011
15. Luo XH, Chang YJ, Xu LP, et al: The impact of graft composition on clinical outcomes in unmanipulated HLA-mismatched/haploidentical hematopoietic SCT. Bone Marrow Transplant 43:29-36, 2009
16. Zhao XY, Chang YJ, Xu LP, et al: Association of natural killer cells in allografts with transplant outcomes in patients receiving G-CSF-mobilized PBSC grafts and G-CSF-primed BM grafts from HLAhaploidentical donors. Bone Marrow Transplant 44: 721-728, 2009
17. Harris AC, Ferrara JL, Levine JE: Advances in predicting acute GVHD. Br J Haematol 160:288-302, 2013
18. Paczesny S: Discovery and validation of graftversus-host disease biomarkers. Blood 121:585-594, 2013
19. Mochizuki K, Kikuta A, Ito M, et al: Feasibility of tacrolimus, methotrexate, and prednisolone as a graft-versus-host disease prophylaxis in non-T-celldepleted haploidentical hematopoietic stem cell transplantation for children. Clin Transplant 25: 892-897, 2011
20. Wang Y, Fu HX, Liu DH, et al: Influence of two different doses of antithymocyte globulin in patients with standard-risk disease following haploidentical transplantation: A randomized trial. Bone Marrow Transplant 49:426-433, 2014
21. Huang XJ, Liu DH, Liu KY, et al: Haploidentical hematopoietic stem cell transplantation without in vitro T-cell depletion for the treatment of hematological malignancies. Bone Marrow Transplant 38: 291-297, 2006 [Erratum: Bone Marrow Transplant 42: 295, 2008]
22. Huang XJ, Liu DH, Liu KY, et al: Donor lymphocyte infusion for the treatment of leukemia relapse after HLA-mismatched/ haploidentical T-cell-replete hematopoietic stem cell transplantation. Haematologica 92:414-417, 2007
23. Huang XJ, Liu DH, Liu KY, et al: Modified donor lymphocyte infusion after HLA-mismatched/ haploidentical T cell-replete hematopoietic stem cell transplantation for prophylaxis of relapse of leukemia in patients with advanced leukemia. J Clin Immunol 28:276-283, 2008
24. Kong Y, Chang YJ, Wang YZ, et al: Association of an impaired bone marrow microenvironment with secondary poor graft function after allogeneic hematopoietic stem cell transplantation. Biol Blood Marrow Transplant 19:1465-1473, 2013
25. Chang YJ, Zhao XY, Xu LP, et al: Donorspecific anti-human leukocyte antigen antibodies were associated with primary graft failure after unmanipulated haploidentical blood and marrow transplantation: A prospective study with randomly assigned training and validation sets. J Hematol Oncol 8:84, 2015
26. Ramsay NK, Kersey JH, Robison LL, et al: A randomized study of the prevention of acute graftversus-host disease. N Engl J Med 306:392-397, 1982
27. Rowlings PA, Przepiorka D, Klein JP, et al: IBMTR Severity Index for grading acute graft-versushost disease: Retrospective comparison with Glucksberg grade. Br J Haematol 97:855-864, 1997
28. Filipovich AH, Weisdorf D, Pavletic S, et al: National Institutes of Health consensus development project on criteria for clinical trials in chronic graftversus-host disease: I. Diagnosis and staging working group report. Biol Blood Marrow Transplant 11: 945-956, 2005
29. Chang YJ, Zhao XY, Huo MR, et al: Immune reconstitution following unmanipulated HLA-mismatched/ haploidentical transplantation compared with HLAidentical sibling transplantation. J Clin Immunol 32: 268-280, 2012
30. Lu DP, Dong L, Wu T, et al: Conditioning including antithymocyte globulin followed by unmanipulated HLA-mismatched/haploidentical blood and marrow transplantation can achieve comparable outcomes with HLA-identical sibling transplantation. Blood 107:3065-3073, 2006
31. Armand P, Gibson CJ, Cutler C, et al: A disease risk index for patients undergoing allogeneic stem cell transplantation. Blood 120:905-913, 2012
32. McCurdy SR, Kanakry JA, Showel MM, et al: Risk-stratified outcomes of nonmyeloablative HLA-haploidentical BMT with high-dose posttransplantation cyclophosphamide. Blood 125: 3024-3031, 2015
33. Sayer HG, Longton G, Bowden R, et al: Increased risk of infection in marrow transplant patients receiving methylprednisolone for graftversus-host disease prevention. Blood 84: 1328-1332, 1994
34. Xu LP, Zhang CL, Mo XD, et al: Epstein-Barr virus-related post-transplantation lymphoproliferative disorder after unmanipulated human leukocyte antigen haploidentical hematopoietic stem cell transplantation: Incidence, risk factors, treatment, and clinical outcomes. Biol Blood Marrow Transplant 21: 2185-2191, 2015
35. Han TT, Xu LP, Liu DH, et al: Prevalence of EBV infection in patients with allogeneic hematopoietic stem cell transplantation (in Chinese). Zhonghua Xue Ye Xue Za Zhi 34:651-654, 2013
36. Sun YQ, Xu LP, Liu DH, et al: The incidence and risk factors of invasive fungal infection after haploidentical haematopoietic stem cell transplantation without in vitro T-cell depletion. Clin Microbiol Infect 18:997-1003, 2012
37. Choi SW, Kitko CL, Braun T, et al: Change in plasma tumor necrosis factor receptor 1 levels in the first week after myeloablative allogeneic transplantation correlates with severity and incidence of GVHD and survival. Blood 112:1539-1542, 2008
38. Hill GR, Crawford JM, Cooke KR, et al: Total body irradiation and acute graft-versus-host disease: The role of gastrointestinal damage and inflammatory cytokines. Blood 90:3204-3213, 1997
39. Bouazzaoui A, Spacenko E, Mueller G, et al: Steroid treatment alters adhesion molecule and chemokine expression in experimental acute graftvs.-host disease of the intestinal tract. Exp Hematol 39:238-249.e1, 2011
40. Theiss-Suennemann J, Jörß K, Messmann JJ, et al: Glucocorticoids attenuate acute graft-versushost disease by suppressing the cytotoxic capacity of CD8(+) T cells. J Pathol 235:646-655, 2015
41. Zheng G, Zhong S, Geng Y, et al: Dexamethasone promotes tolerance in vivo by enriching CD11clo CD40lo tolerogenic macrophages. Eur J Immunol 43:219-227, 2013
42. Xiao-Jun H, Lan-Ping X, Kai-Yan L, et al: Partially matched related donor transplantation can achieve outcomes comparable with unrelated donor transplantation for patients with hematologic malignancies. Clin Cancer Res 15:4777-4783, 2009
43. Zhang XH, Wang GX, Zhu HH, et al: Recruitment of CD8(+) T cells into bone marrow might explain the suppression of megakaryocyte apoptosis through high expression of CX3CR1(+) in prolonged isolated thrombocytopenia after allogeneic hematopoietic stem cell transplantation. Ann Hematol 94: 1689-1698, 2015