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資料4 Ⅳ-112,140_メトトレキサート［1.5MB］ (34 ページ)
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| 出典情報 | 医療上の必要性の高い未承認薬・適応外薬検討会議（第67回 2／6）《厚生労働省》 |
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（公知申請への該当性に係る企業見解の様式）
要望番号；IV-112
transplantation from unrelated donors. Blood 2000;96(6):2062-8.
25. Hamilton BK, Liu Y, Hemmer MT, et al. Inferior Outcomes with Cyclosporine and
Mycophenolate Mofetil after Myeloablative Allogeneic Hematopoietic Cell Transplantation.
Biol Blood Marrow Transplant 2019;25(9):1744-55.
26. Chhabra S, Liu Y, Hemmer MT, et al. Comparative Analysis of Calcineurin Inhibitor-Based
Methotrexate and Mycophenolate Mofetil-Containing Regimens for Prevention of Graft-versusHost Disease after Reduced-Intensity Conditioning Allogeneic Transplantation. Biol Blood
Marrow Transplant 2019;25(1):73-85.
27. Cutler C, Logan B, Nakamura R, et al. Tacrolimus/sirolimus vs tacrolimus/methotrexate as
GVHD prophylaxis after matched, related donor allogeneic HCT. Blood 2014;124(8):1372-7.
28. Bensinger W, Stem Cell Trialists’ Collaborative Group. Individual patient data meta-analysis of
allogeneic peripheral blood stem cell transplant vs bone marrow transplant in the management
of hematological malignancies: indirect assessment of the effect of day 11 methotrexate
administration. Bone Marrow Transplant 2006;38(8):539-46.
29. Ram R, Gafter-Gvili A, Yeshurun M, et al. Prophylaxis regimens for GVHD: systematic review
and meta-analysis. Bone Marrow Transplant 2009;43(8):643-53.
30. Kharfan-Dabaja MA, Reljic T, Kumar A, et al. Omission of day +11 methotrexate dose and
allogeneic hematopoietic cell transplantation outcomes: results of a systematic review/metaanalysis. Bone Mrrow Transplant 2022;57(1):65-71.
31. Appelbaum FR. Harrison's Principles of Internal Medicine, 20e, Chapter 110: Hematopoietic
Cell Transplantation. McGraw-Hill, 2021.
32. Forman SJ, Negrin RS, Antin JH, et al. Thomas' Hematopoietic Cell Transplantation: Stem Cell
Transplantation, 5th Ed. Wiley Blackwell;2016.
33. Kaushansky K, Lichtman MA, Prchal JT, et al, Williams Hematology. 9th ed. McGrawHill;2016.
34. Greer JP, Arber DA, Glader BE, et al. Wintrobe's Clinical Hematology. 14th ed. Wolters Kluwer,
2019.
35. 造血幹細胞移植の基礎と臨床 改訂 3 版 神田善伸編, p465.
36. GVHD（移植片対宿主病）の基礎と臨床 豊嶋崇徳編, p208-11.
37. 日本造血・免疫細胞療法学会. 造血細胞移植ガイドライン GVHD（第 6 版）2025.
38. Kanda J, Brazauskas R, Hu Z-H, et al. Graft-versus-Host Disease after HLA-Matched Sibling
Bone Marrow or Peripheral Blood Stem Cell Transplantation: Comparison of North American
Caucasian and Japanese Populations. Biol Blood Marrow Transplant 2016;22(4):744-51.
39. Terakura S, Atsuta Y, Tsukada N, et al. Comparison of Outcomes of 8/8 and 7/8 Allele-Matched
Unrelated Bone Marrow Transplantation and Single-Unit Cord Blood Transplantation in Adults
with Acute Leukemia. Biol Blood Marrow Transplant 2016;22(2):330-8.
40. Gondo H, Harada M, Taniguchi S, et al. Cyclosporine combined with methylprednisolone or
30
要望番号；IV-112
transplantation from unrelated donors. Blood 2000;96(6):2062-8.
25. Hamilton BK, Liu Y, Hemmer MT, et al. Inferior Outcomes with Cyclosporine and
Mycophenolate Mofetil after Myeloablative Allogeneic Hematopoietic Cell Transplantation.
Biol Blood Marrow Transplant 2019;25(9):1744-55.
26. Chhabra S, Liu Y, Hemmer MT, et al. Comparative Analysis of Calcineurin Inhibitor-Based
Methotrexate and Mycophenolate Mofetil-Containing Regimens for Prevention of Graft-versusHost Disease after Reduced-Intensity Conditioning Allogeneic Transplantation. Biol Blood
Marrow Transplant 2019;25(1):73-85.
27. Cutler C, Logan B, Nakamura R, et al. Tacrolimus/sirolimus vs tacrolimus/methotrexate as
GVHD prophylaxis after matched, related donor allogeneic HCT. Blood 2014;124(8):1372-7.
28. Bensinger W, Stem Cell Trialists’ Collaborative Group. Individual patient data meta-analysis of
allogeneic peripheral blood stem cell transplant vs bone marrow transplant in the management
of hematological malignancies: indirect assessment of the effect of day 11 methotrexate
administration. Bone Marrow Transplant 2006;38(8):539-46.
29. Ram R, Gafter-Gvili A, Yeshurun M, et al. Prophylaxis regimens for GVHD: systematic review
and meta-analysis. Bone Marrow Transplant 2009;43(8):643-53.
30. Kharfan-Dabaja MA, Reljic T, Kumar A, et al. Omission of day +11 methotrexate dose and
allogeneic hematopoietic cell transplantation outcomes: results of a systematic review/metaanalysis. Bone Mrrow Transplant 2022;57(1):65-71.
31. Appelbaum FR. Harrison's Principles of Internal Medicine, 20e, Chapter 110: Hematopoietic
Cell Transplantation. McGraw-Hill, 2021.
32. Forman SJ, Negrin RS, Antin JH, et al. Thomas' Hematopoietic Cell Transplantation: Stem Cell
Transplantation, 5th Ed. Wiley Blackwell;2016.
33. Kaushansky K, Lichtman MA, Prchal JT, et al, Williams Hematology. 9th ed. McGrawHill;2016.
34. Greer JP, Arber DA, Glader BE, et al. Wintrobe's Clinical Hematology. 14th ed. Wolters Kluwer,
2019.
35. 造血幹細胞移植の基礎と臨床 改訂 3 版 神田善伸編, p465.
36. GVHD（移植片対宿主病）の基礎と臨床 豊嶋崇徳編, p208-11.
37. 日本造血・免疫細胞療法学会. 造血細胞移植ガイドライン GVHD（第 6 版）2025.
38. Kanda J, Brazauskas R, Hu Z-H, et al. Graft-versus-Host Disease after HLA-Matched Sibling
Bone Marrow or Peripheral Blood Stem Cell Transplantation: Comparison of North American
Caucasian and Japanese Populations. Biol Blood Marrow Transplant 2016;22(4):744-51.
39. Terakura S, Atsuta Y, Tsukada N, et al. Comparison of Outcomes of 8/8 and 7/8 Allele-Matched
Unrelated Bone Marrow Transplantation and Single-Unit Cord Blood Transplantation in Adults
with Acute Leukemia. Biol Blood Marrow Transplant 2016;22(2):330-8.
40. Gondo H, Harada M, Taniguchi S, et al. Cyclosporine combined with methylprednisolone or
30