JP7489397B2 - R-chopとの組み合わせ及び複合薬におけるチダミドの適用 - Google Patents
R-chopとの組み合わせ及び複合薬におけるチダミドの適用 Download PDFInfo
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- JP7489397B2 JP7489397B2 JP2021551329A JP2021551329A JP7489397B2 JP 7489397 B2 JP7489397 B2 JP 7489397B2 JP 2021551329 A JP2021551329 A JP 2021551329A JP 2021551329 A JP2021551329 A JP 2021551329A JP 7489397 B2 JP7489397 B2 JP 7489397B2
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- WXHHICFWKXDFOW-BJMVGYQFSA-N n-(2-amino-5-fluorophenyl)-4-[[[(e)-3-pyridin-3-ylprop-2-enoyl]amino]methyl]benzamide Chemical compound NC1=CC=C(F)C=C1NC(=O)C(C=C1)=CC=C1CNC(=O)\C=C\C1=CC=CN=C1 WXHHICFWKXDFOW-BJMVGYQFSA-N 0.000 title claims description 22
- 229940000425 combination drug Drugs 0.000 title description 9
- 208000031671 Large B-Cell Diffuse Lymphoma Diseases 0.000 claims description 18
- 206010012818 diffuse large B-cell lymphoma Diseases 0.000 claims description 18
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Description
1.組織病理学的にびまん性大細胞型B細胞リンパ腫と診断され、CD20陽性;
2.年齢:61歳以上、75歳以下;
3.ECOGの身体状態スコア:0、1、又は2ポイント;
4.悪性腫瘍の病歴がなく、同時に他の腫瘍の発生なし;
5.治験責任医師の判断によると、少なくとも6か月の平均余命を有する患者;
6.患者またはその法定代理人は、特別な検査又は研究手順を行う前に、書面でインフォームドコンセントを提供しなければならない;
7.国際予後指標(IPI):>1ポイント
1.研究対象の薬剤の名称と投与量を以下の表に示し、以下の表の投与方法を患者に適用した。
(1)骨髄抑制後、好中球と血小板の総数は上昇段階にあった;
(2)次の治療コースの初日に、血中好中球≧1.0×109/L、WBC≧3.0×109/L;
(3)次の治療コースの初日、血小板数≧75×109/L;
満たされない場合は、次の治療コースを3~4日間遅らせ、血液細胞検査を繰り返す必要がある。それでも上記の指標に達しない場合は、上記の化学療法基準が満たされるまで、治療はさらに3~4日間延期される。治療が14日以上延期され、それでも基準が満たされない場合、患者は治療を中止し、これは有害事象として記録される。患者は、プロトコルの要求に応じて絶えずフォローアップされる。
(1)グレード2以上の神経毒性を有する患者の場合、VCRは1mgに減少した、
(2)好中球または血小板の総数が不十分な場合は、化学療法薬の削減を検討する必要がある。これは、以下の標準を参照して実行され得る:
[1]次の治療コースの遅延時間が0~7日以内の場合:元の投与量を維持する必要がある;
[2]次の治療コースの遅延時間が8~14日以内の場合、又は最後の治療コースでグレード4の骨髄抑制が発生した場合は、次のように投与量を調整する必要がある:
CTX 75%
EPI 75%
VCR 100%
Pred 100%
チダミド 100%
化学療法の最初のコースでは、大きな腫瘍量(巨大な腫瘤又は500u/L以上の乳酸デヒドロゲナーゼ)又はPSが2又は胃腸NHL(胃腸穿孔の予防)を有する患者には、アロプリノールと重曹を投与する必要があり、プレドニゾンは最初に経口投与することができ、必要に応じて、腫瘍崩壊症候群を予防するために化学療法を2日で投与することができる。
Claims (8)
- B細胞リンパ腫を治療するための医薬の製造における、チダミドの使用であって、該医薬は、以下の表の投与方法に従って、リツキシマブ(R)、シクロホスファミド(CTX)、エピルビシン(EPI)、ビンクリスチン(VCR)及びプレドニゾン(Pred)と組み合わせて投与される、
上記使用。 - 前記B細胞リンパ腫が、びまん性大細胞型B細胞リンパ腫である、請求項1に記載の使用。
- 前記びまん性大細胞型B細胞リンパ腫が、CD20陽性である、請求項2に記載の使用。
- チダミドと
リツキシマブ(R)、シクロホスファミド(CTX)、エピルビシン(EPI)、ビンクリスチン(VCR)及びプレドニゾン(Pred)との投与が、21日間毎に1回、6コース繰り返される、請求項1~3のいずれか一項に記載の使用。 - チダミドを含む、B細胞リンパ腫の治療のための医薬組成物であって、該医薬組成物は、以下の表の投与方法に従って、
リツキシマブ(R)、シクロホスファミド(CTX)、エピルビシン(EPI)、ビンクリスチン(VCR)及びプレドニゾン(Pred)と組み合わせて投与される、
上記医薬組成物。 - 前記B細胞リンパ腫が、びまん性大細胞型B細胞リンパ腫である、請求項5に記載の医薬組成物。
- 前記びまん性大細胞型B細胞リンパ腫が、CD20陽性である、請求項6に記載の医薬組成物。
- チダミドと
リツキシマブ(R)、シクロホスファミド(CTX)、エピルビシン(EPI)、ビンクリスチン(VCR)及びプレドニゾン(Pred)との投与が、21日間毎に1回、6コース繰り返される、請求項5~7のいずれか一項に記載の医薬組成物。
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