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2 ,328 C 6426 H 9900 N 1700 O 2008 S , ,

3 (1) CD20 B CD20 (2) infusion reaction infusion-associated symptom CD20 B 1 375mg/m

4 Heavy Chain 1 Gln Val Gln Leu Gln Gln Pro Gly Ala Glu 11 Leu Val Lys Pro Gly Ala Ser Val Lys Met 21 Ser Cys Lys Ala Ser Gly Tyr Thr Phe Thr 31 Ser Tyr Asn Met His Trp Val Lys Gln Thr 41 Pro Gly Arg Gly Leu Glu Trp Ile Gly Ala 51 Ile Tyr Pro Gly Asn Gly Asp Thr Ser Tyr 61 Asn Gln Lys Phe Lys Gly Lys Ala Thr Leu 71 Thr Ala Asp Lys Ser Ser Ser Thr Ala Tyr 81 Met Gln Leu Ser Ser Leu Thr Ser Glu Asp 91 Ser Ala Val Tyr Tyr Cys Ala Arg Ser Thr 101 Tyr Tyr Gly Gly Asp Trp Tyr Phe Asn Val 111 Trp Gly Ala Gly Thr Thr Val Thr Val Ser 121 Ala Ala Ser Thr Lys Gly Pro Ser Val Phe 131 Pro Leu Ala Pro Ser Ser Lys Ser Thr Ser 141 Gly Gly Thr Ala Ala Leu Gly Cys Leu Val 151 Lys Asp Tyr Phe Pro Glu Pro Val Thr Val 4

5 161 Ser Trp Asn Ser Gly Ala Leu Thr Ser Gly 171 Val His Thr Phe Pro Ala Val Leu Gln Ser 181 Ser Gly Leu Tyr Ser Leu Ser Ser Val Val 191 Thr Val Pro Ser Ser Ser Leu Gly Thr Gln 201 Thr Tyr Ile Cys Asn Val Asn His Lys Pro 211 Ser Asn Thr Lys Val Asp Lys Lys Ala Glu 221 Pro Lys Ser Cys Asp Lys Thr His Thr Cys 231 Pro Pro Cys Pro Ala Pro Glu Leu Leu Gly 241 Gly Pro Ser Val Phe Leu Phe Pro Pro Lys 251 Pro Lys Asp Thr Leu Met Ile Ser Arg Thr 261 Pro Glu Val Thr Cys Val Val Val Asp Val 271 Ser His Glu Asp Pro Glu Val Lys Phe Asn 281 Trp Tyr Val Asp Gly Val Glu Val His Asn 291 Ala Lys Thr Lys Pro Arg Glu Glu Gln Tyr 301 Asn Ser Thr Tyr Arg Val Val Ser Val Leu 311 Thr Val Leu His Gln Asp Trp Leu Asn Gly 321 Lys Glu Tyr Lys Cys Lys Val Ser Asn Lys 331 Ala Leu Pro Ala Pro Ile Glu Lys Thr Ile 5

6 341 Ser Lys Ala Lys Gly Gln Pro Arg Glu Pro 351 Gln Val Tyr Thr Leu Pro Pro Ser Arg Asp 361 Glu Leu Thr Lys Asn Gln Val Ser Leu Thr 371 Cys Leu Val Lys Gly Phe Tyr Pro Ser Asp 381 Ile Ala Val Glu Trp Glu Ser Asn Gly Gln 391 Pro Glu Asn Asn Tyr Lys Thr Thr Pro Pro 401 Val Leu Asp Ser Asp Gly Ser Phe Phe Leu 411 Tyr Ser Lys Leu Thr Val Asp Lys Ser Arg 421 Trp Gln Gln Gly Asn Val Phe Ser Cys Ser 431 Val Met His Glu Ala Leu His Asn His Tyr 441 Thr Gln Lys Ser Leu Ser Leu Ser Pro Gly 451 Lys Gal GlcNAc Man Fuc Man GlcNAc GlcNAc Asn 301 Gal GlcNAc Man 6

7 Light Chain 1 Gln Ile Val Leu Ser Gln Ser Pro Ala Ile 11 Leu Ser Ala Ser Pro Gly Glu Lys Val Thr 21 Met Thr Cys Arg Ala Ser Ser Ser Val Ser 31 Tyr Ile His Trp Phe Gln Gln Lys Pro Gly 41 Ser Ser Pro Lys Pro Trp Ile Tyr Ala Thr 51 Ser Asn Leu Ala Ser Gly Val Pro Val Arg 61 Phe Ser Gly Ser Gly Ser Gly Thr Ser Tyr 71 Ser Leu Thr Ile Ser Arg Val Glu Ala Glu 81 Asp Ala Ala Thr Tyr Tyr Cys Gln Gln Trp 91 Thr Ser Asn Pro Pro Thr Phe Gly Gly Gly 101 Thr Lys Leu Glu Ile Lys Arg Thr Val Ala 111 Ala Pro Ser Val Phe Ile Phe Pro Pro Ser 121 Asp Glu Gln Leu Lys Ser Gly Thr Ala Ser 131 Val Val Cys Leu Leu Asn Asn Phe Tyr Pro 141 Arg Glu Ala Lys Val Gln Trp Lys Val Asp 151 Asn Ala Leu Gln Ser Gly Asn Ser Gln Glu 161 Ser Val Thr Glu Gln Asp Ser Lys Asp Ser 171 Thr Tyr Ser Leu Ser Ser Thr Leu Thr Leu 181 Ser Lys Ala Asp Tyr Glu Lys His Lys Val 191 Tyr Ala Cys Glu Val Thr His Gln Gly Leu 201 Ser Ser Pro Val Thr Lys Ser Phe Asn Arg 211 Gly Glu Cys

8 mL 10mg 10mL 50mL CD20 mg/ IDEC Pharmaceuticals Corporation 1991 IDEC-C2B8 CD20 IDEC-2B8 1 B CD20 CDC ADCC 1995 Genentech IDEC Genentech B Genentech Roche International EMEA IDEC Genentech IDEC 8

9 IDEC Genentech B CD IgG CD20 SB BALB/c CD20 CD20 1 CHO CD20 MCB MCB WCB WCB MCB WBC 9

10 ph ph ph / 20 2 ph 10

11 CD20 CD20 100mg/kg 4 8 B 16.8mg/kg/ 2 20mg/kg/ IgG DNA 6 Cmax AUC g/ml 11

12 B 20mg/kg 10mg/kg mg/kg CD mg/kg g/ml 250mg/m g/ml 100mg/kg Cmax g/ml AUC g hr/ml 250mg/m 2 Cmax g/ml AUC g hr/ml B mg/kg B CD20 Fc Fc Fc Fc B Fc Fc TNF 6 IL-6 12

13 TNF Blick M.: Cancer Res 47:2986, 1987 CD20 CDC ADCC CD20 B B B CD20 IgG B B CD20 in vitro in vivo B in vitro CDC ADCC In vitro IDEC-2B8 SB CD20 13

14 125 I-B1 B1 CD20 Coulter 125 I 2 1,000 ng/well IC 50 B1 Leu 16 CD20 Becton-Dikinson 1/2 1/3 2 20,000 ng/well 125 I IDEC-2B8 SB IDEC-2B8 SB 125 I 125 I- IDEC-2B8 Scatchard CD mol/l IDEC-2B mol/l B B In vivo B mg/kg 4 B mg/kg B 0.4 mg/kg 4 6.4mg/kg B mg/kg B mg/kg B 15 B CDC SB C1q Complement component 1q IDEC-2B8 SB 2.2 g/ml SB 50 HSB CD20 CD20 CDC IDEC-2B8 ADCC 3.9 g/ml SB 50 HBS CD20 ADCC IDEC-2B8 20 g/ml CFU-GM:Colony-Forming Unit-Granulocyte-Macrophage BFU-E:Burst-Forming Unit-Erythroid CFU-GEMM: 14

15 Colony-Forming Unit-Granulocyte-Erythroid-Monocyte-Macrophage CD34 ( ) g/ml B 0.01 mg/kg/day 0.1 mg/kg/day B 0.4 mg/kg/day 1.6 mg/kg/day 8 B B B 15 B B 0.4 mg/kg/day mg/kg 6.4 mg/kg B B B 0.25, mg/kg/day 1 4 B B 1 B mg/kg/day 1 4 B mg/kg/day 1 4 B % % B B B 16.8 mg/kg/day mg/kg/day 4 B 15

16 B SB B B Fc ADCC CDC B 16.8 mg/kg/day 1 4 B B B 16.8 mg/kg/day / 375 mg/m mg/kg/day mg/m in vitro µg/ml CDC ADCC in vitro B 16.8 mg/kg/day mg/kg/day µg/ml 40 µg/ml 375 mg/m 2 Cmax g/ml g/ml 20 g/ml CD20 SB HSB 16

17 CD20 Fc Fc natural killer TNF IL-1 IL-6 IL-8 Blood 94: 2217, 1999 CD20 CD20 TNF IL-1 IL-6 IL-8 recombinant-tnf TNF Ca BUN GOT GPT ALP 13:3491, 1986 Ther Res 7:336,1987 Cancer Chemother Pharmacol 20:223, 1989 Cancer Res 47:2986, 1987 Cancer Chemother Pharmacol 20:137, 1987 TNF BUN mg/kg Cmax AUC mg/kg g/ml g/ml monkey anti-chimeric antibody MACA 17

18 B mg/m 2 Cmax AUC t 1/2 MRT mg/m AUC 375 mg/m 2 Cmax AUC 250 mg/m 2 Cmax AUC mg/m 2 B % t 1/2 (1 ) B natural killer ADCC CDC B B B IgG IgA Ann Oncol 9:995, 1998 IDEC-C2B8-2 MACA 18

19 1 4 8 B B B bulky disease B B B humun anti-chimeric antibody HACA HACA HACA HACA Blood 83:435, % B T (500mg/m 2 No. No. No. ) (250mg/m 2 No. No. No. ) (250mg/m 2 No. No. No. ) No. bulky mass 100 mg/m 2 No. ( ) (CD20 ) 19

20 . 1) I IDEC-C2B8-1 Ann Oncol 9:527, 1998 B I ( ) (Blood 90:2188, 1997) 1 375mg/m I 1 2/ mg/m 2 2 CD20 B Performance Status (PS: Eastern Cooperative Oncology Group (Am J Clin Oncol 5:649, 1982) ( 3,000 / L 1,200 / L 75,000 / L GOT GPT 3 x 2.0mg/dL 1.5mg/dL PaO 2 60mmHg) HAMA 5,000/ L 1 250mg/m 2 3 Grade 2 Grade 3 Japan Clinical Oncology Group(JCOG) ( 39:1331, 1993) 1 375mg/m 2 250mg/m 2 Grade 3 Grade Grade mg/m 2 Grade (MTD) 1mg/mL 0.2 m Grade mg/ 1 100mg/ 200mg/ Grade 2 Grade 1 20

21 Grade 1 25mg/ Grade 3 Grade 1 25mg/ mg 30mg 250mg 4 ( 1 1 ) 375mg 8 (1 1 HAMA 2 ) 250mg 1 250mg ( ) ( ) 375mg ( ) ( ) 250mg (4 ) (Grade 3) (Grade 3:1 ) 1 (Grade4) 375mg (8 ) (Grade 3:1 ) 5 (Grade 3:2 ) 1 (Grade 3) ( ) 1 (375mg ) (Grade 2) Grade 2 (Na Cl) Grade 3 1 B (CD19 CD20 ) 1 3 T (CD3 ) 3 (IgA IgM IgG) (C 3 ) 12 HAMA HACA (WHO ) 250mg ( 3 ) CR1 ( 8 +) PR1 ( 5 +) follicular large 375mg (8 ) CR1 (follicular mixed 6 +) PR4 (follicular mixed3 follicular large1 21

22 ) 1 375mg/m ) IDEC-C2B8-2 B 90 Working Formulation(WF) (Cancer 49:2112, 1982) A E Revised European-American Lymphoma Classification(REAL Blood 84:1361, 1994) peripheral neoplasms 1 6 CD20 B ( 1,200 / L 75,000 / L GOT GPT 4 2 x 1.5 x PaO 2 65mmHg) P.S I 1 G-CSF(granulocyte colony stimulating factor) 1 375mg/m I Grade 3 1 Grade CR PR B 1 3 HACA J Clin Oncol 16:2825, 1998 CR u(uncertain CR) (J Clin Oncol 7:1630, 1989) CR u CR 90 I(mantle cell lymphoma B )69 (mantle cell lymphoma) P.S. Ann Arbor : Cancer Res 31:1860, 1971 International Prognostic Index N Engl J Med 329:987, 1993 I / 33 /36 0/1/2:53 /13 /3 61 follicular small cell:14 follicular mixed 36 follicular large 6 lymphoplasmacytoid 1 marginal zone lymphoma 4 / / 8 /24 /37 5cm 17 22

23 5cm Low /Low-Intermediate /High - Intermediate 34 /29 / / 17 /4 0/1/2:11 /8 /2 13 mantle cell / 4 /17 5cm 4 5cm / 6 2 (1 9) 12 (2 162) Low /Low-Intermediate /High-Intermediate /High 5 /9 /5 /2 13 follicular small cell 2 follicular mixed 4 follicular large 6 mantle cell 1 I I 69 8 (1 B 2 5 mantle cell 1 diffuse large 4 ) MRSA 1 C 1 5,000/ L 2 3 diffuse large 1 follicular mixed 2 I 1 (1 ) 3 (1 Grade 3 1 Grade ) I 1 (1 2 2 ) 1 (Grade ) I 53.6% 69 CR14 PR23 8 PR4 28.6% 21 PR6 8 PR1 37.5% 16 PR6 3 PR2 I % % CD19 CD20 B 3 B 6 12 IgA IgM IgG I % 66.7%(60 Grade 3:4 ) 37.8%(34 Grade 3:1 ) 23.3%(21 ) 17.8%(16 ) 16.7%(15 Grade 3:1 ) 28.9%(26 Grade 3:1 ) 16.7%(15 Grade 3:1 ) 12.2%(11 ) 25.6%(23 ) 11.1%(10 ) 10%(9 ) 10%(9 ) 27.8%(25 ) 21.1%(19 Grade 3:1 ) Grade 2 (Grade 2) 23

24 Grade 1/2/3 228 /61 / Grade 1/2 66 / Grade 1/2 50 / (Grade 1/2 29 /3 ) Grade Grade 2 Grade ( 1 1 ) 1 3 Grade 2 LDH 25/65 14/25 p=0.010 Fisher s exact test ( 0 1 7/70 2 7/20 p=0.035) / /20 p= /60 18/30 p=0.041 ) 50 (Grade 3/4:13 /1 ) 12.5 (1 266) 13 (3 125) 50 (Grade 3/4:13 /5 ) 29.5 (1 266) 14 (3 154) 18 (Grade 3/4:0 /0 ) 20 (1 178 ) 7 (2 63) 14 (Grade 3/4:2 /1 ) 2 (0 201) 5.5 (2 42) GPT 6 GOT 10 ALP BUN 4 Ca (Grade 3) HACA HACA 2 ( ) 6 ( 2 (Grade 3:1 ) 1 ) Grade 3 11 (Grade 3:1 ) 11 (Grade 3:1 ) 24

25 2 (Grade 3:1 ) ) B WF small lymphocytic follicular small cleaved cell follicular mixed follicular large diffuse small cleaved cell (mantle cell lymphoma) diffuse mixed diffuse large immunoblastic B follicular lymphoma (N Engl J Med 328:1023,1993) WF REAL 1994 REAL REAL indolent(low risk) aggressive(intermediate risk) very aggressive(high risk) (Blood 88:4085, 1996) REAL peripheral B-cell neoplasms indolent small lymphocytic lymphoplasmacytoid lymphoma follicle center lymphoma, follicular(small cell mixed small and large cell) marginal zone B-cell lymphoma splenic marginal zone lymphoma follicular cell large cell mantle cell aggressive 7 10 (J Clin Oncol 3:299, 1985) Ann Arbor I 10 50% (Cancer 52:2300, 1983) Ann Arbor ( N Engl J Med 311:1471, 1984) CPA DOX (C-MOPP (CPA/VCR/procarbazine/prednisolone(PSL)) ) DOX (CHOP ) (Blood 83:881, 1994) (J Clin Oncol 15:445, 1997 J Clin Oncol 13:1096, 1995) Interferon- (N Engle J Med 311:1148, 1984 Proc Am Soc Clin Oncol 17:4a,

26 (abstr#11) ) (fludarabine(j Clin Oncol 10:790,1992) cladribine(j Clin Oncol 10:371,1992)) 3 5 B (Blood 85:1075, 1995) CHOP CVP(CPA/VCR/PSL) (Hematol Oncol 7:365, 1989) B 2) B B I J Clin Oncol 15:3266, (PR) B Blood 90:2188, mg/m CR3 PR14 B J Clin Oncol 16:2825, ( ) follicular130 ( follicular large cell10 ) small lymphocytic33 (mantle cell )3 97% 25% 14% 48%(PR42% CR6%) 12.5 (J Clin Oncol 16:2825, 1998) small lymphocytic 4/33 follicular 1 375mg/m small lymphocytic lymphoma (J Clin Oncol 18:317, 2000) (32 ) 38%(CR5 PR7 ) (35 ) 37%(CR5 PR8 ) small lymphocytic 14%(4/28 PR) B 10cm ( B: J Clin Oncol 17:1851, 1999) 1 375mg/m ( ) follicular 22 small lymphocytic 9 39% (CR1 PR11 ) 8.1 B Ann Arbor (I ) (Blood 26

27 95:3052, 2000) 1 375mg/m stable disease ( ) follicular 26 small lymphocytic 15 I follicular 52%(13/25 ) small lymphocytic 57%(8/14 ) %(25/39 CR6 ) B ( R) (J Clin Oncol 18:3135, 2000) 1 375mg/m ( ) follicular57 small lymphocytic ( ) 1 ( CHOP 5 interferon 4 ) 38%(CR6 PR17 ) CHOP B CHOP (3 6 ( ) CPA750mg/m 2 (day1) DOX50mg/m 2 (day1) VCR1.4mg/m 2 ( 2mg/body day1) PSL100mg/m 2 (day1 5)) 1 375mg/m 2 6 (day ) 40 ( ) small lymphocytic 9 follicular 31 Ann Arbor I/ %(CR22 PR16 ) CHOP ( : J Clin Oncol 17:268, 1999) CD20 ( follicular lymphoma 1 Clin Cancer Res 5:611, J Clin Oncol 16:3916, 1998) 3) B B diffuse large B cell lymphoma Blood 92:1927, mg/m (17 27

28 ) 375mg/m mg/m (13 ) 37%(11/30 ) diffuse large B cell lymphoma /CHOP CHOP ( LNH-98.5 Abstract No.950 American Society of Hematology, the 42nd meeting ) Ann Arbor PS0 2 CHOP 3 8 CHOP 375mg/m 2 CHOP 3 8 CHOP 159 (70 41% / 79%) 169 (70 52% / 78%) (CR CRu ) CHOP 60% 76% PR 6% 1 CHOP 49% 68% 69%(p< log-rank ) 83%(p<0.001 log-rank ) Grade3/4 CHOP (159 ) (169 ) infusion Grade 3/ infusion CHOP diffuse large B cell lymphoma CHOP CHOP B /CHOP ( day 1/CHOP day ) ( ) 33 ( 52 (20 79)) Ann Arbor I/ 9 / 24 follicular large 7 diffuse large cell 22 diffuse large cell 2 immunoblastic cm 6 94%(CR20 PR11 ) (J Clin Oncol 19:389, 2001) CHOP B B National Cancer Institute NCI B I/ /Interleukin-2 ( URCC-U4497, NCI-G / ( NCI-00-C-1033, NCI-1033) / / ( SWOG-S0014) / vs ( E-1496) 28

29 / vs ( EORTC-20981)) B ( I/ / ( NCI-93-C-0133L, NCI-T N, NCI-MB-303) / ( MSKCC-99092, NCI-G ) / ( WHC-99365, NCI-V ) ( MSGCC-9740, NCI-V ) / ( AMGEN-GCSF , NCI-V ) / vs ( SWOG-0019) / vs ( UNMC , NCI-G , UCLA-HSPC ) vs ( SWS-SAKK-35/98, EU-98009, ICR-35/98)) B / ( UCLA NCI-G ) / ( NCCTG-N9981) / ( UNMC , NCI-V ) ( UNMC , NCI-V )) ( /cgi-bin/srchcgi.exe) B ( 67 IDEC-C2B8-3) B /CHOP vs CHOP ( 68 IDEC-C2B8-4) 4) B B B B ( ) 1) IDEC-C2B8-2) B 29

30 CD20 B B B IDEC-2 B IDEC-C2B8-3 J Clin Onc 18:317, 2000 CD20 B CD20 IDEC-C2B8-2 ( Blood 95:3052, 2000 / J Clin Oncol 17:268, 1999) http: // cancernet.nci.nih. gov/cgi-bin/srchcgi.exe IDEC-C2B8-4 2) CD20 CD20 CD20 CD20 CD20 B1 L26 CD20 DAKO CD20 B1 N Engl J Med 317:1452, 1987 L26 Am J Pathol 136:1215, 1990 B 30

31 IDEC-C2B8-2 L26 86 CD20 CD20 77:2041, 2000 CD20 B IDEC-C2B8-2 I 67 5 (4 diffuse large 1 mantle cell) 19 3 (2 follicular mixed 1 diffuse large) 39:739, , mg/m ) In vitro 50% CD20 CDC 2.2 g/ml ADCC 3.9 g/ml B I (Blood 84:2457, 1994) 1 (mg/m 2 ) 10(3 ) 50(3 ) 100(3 ) 250(3 ) 500(3 ) mg/m ( ) 6 10 g/ml 14 31

32 mg/m PR ( mg/m 2 1 ) 1 100mg/m 2 B I (J Clin Oncol 15:3266, 1997) I 500mg/m 2 1/4 125mg/m 2 (3 ) 250(7 ) 375mg/m 2 (9 ) I mg/m 2 n=3 PR1 TTP mg/m 2 (6 ) PR2 TTP mg/m 2 (9 ) PR3 TTP mg/m B (Blood 90:2188, 1997) CD20 (Blood 69: 584, 1987) 37 ( 58 (29 81) WF %(CR3 PR14 ) ( ) % 73% 37.8% 16.2% 16.2% 16.2% 18.9% 10.8% 18.9% 16.2% 10.8% 13.5% 13.5% HAMA 1 HACA B 1 375mg/m ) ( ) B 1 375mg/m B I IDEC-C2B8-1) 2/3 250mg/m 2 (4 ) 375mg/m 2 (8 )

33 250mg/m 2 CR1 8 PR mg/m 2 PR4 CR1 I B 1 375mg/m IDEC-C2B8-2) B (J Clin Oncol 16:2825, 1998) 3) B 1 375mg/m B 1 375mg/m 2 IDEC-C2B8-2) (2 ) 8 ( PR PR 2 ) HACA B ( 1 375mg/m ) 60 ( ) 38.3%(CR6 PR17 ) ( ) (J Clin Oncol 18:3135, 2000) 1) 33

34 IDEC-C2B8-2) ( Grade 3/4:13 /1 ) 50 ( Grade 3/4:13 /5 ) ( Grade 3/4:2 /1 ) (Grade JCOG 39:1331, 1995 ) (J Clin Oncol 16:2825, 1998) ( Grade 3:1 ) 7 ( Grade 4:1 ) 2 ( Grade 3:1 ) 6 (Grade 3:1 ) (Grade NCI common toxicity criteria (Ver 1) JCOG ) ( 3,000/ L 1,500/ L 75,000/ L 8.0g/dL 1,200/ L 75,000/ L ) ( ) 12.5 (1 266) 13 (3 125) 29.5 (1 266) 14 (3 154) 20 (1 178) 7 (2 63) 2 (0 201) 5.5 (2 42) 25/50 25/40 p= /50 29/40 p=0.003 LDH 35/65 15/25 p= /65 9/25 p=0.020 PS0 7/64 PS1 2 7/26 p=0.022 Fisher s exact test Grade B I 1 ( mg/m 2 ) (J Clin Oncol 15:3266, 1997) B Fc (J Clin Oncol 15:3266, 1997 Blood 94:2217, 1999) 34

35 [ ] 1 4 2) B ( 1 375mg/m mg/ J Clin Oncol 16:2825, 1998) (Grade3/4 18 /2 ) 84 (53 (Grade 3:2 )) (53 (Grade 3:1 )) (25 ) (27 (Grade 3:1 )) Grade (Grade 3:1 ) 5 ( 10 1 ) 33% % % % ( 1 4 ) 15 (Grade 3: ) 4 IDEC-C2B8-2) 90 2 (1 1 1 Grade 3) 35

36 Genentech IDEC infusion-related Doctor Letter ( EMEA ) ,000 14, (ARDS) 1 PSUR( ) , infusion-associated symptom ( / 18 /15 1 ) 9 infusion-associated symptom 50,000/mm 3 bulky disease (5 ) (1 ) (3 ) B ( 375mg/m 2 3 (1 50mg 2 150mg mg) Blood 94:2217, 1999) 11 4 (Grade 3/4:9 /1 ) 50,000/ L 90 TNF IL-6 50,000/ L cytokine-release syndrome K Ca J Clin Oncol 17:791, PSUR , Doctor Letter 36

37 EMEA 2 1) 2) 3) B J Clin Oncol 16:2825, (8 Grade3/4 2 /1 ) 1 Grade B (Blood 90:2188, 1997)

38 [ ] GCP GCP 4. B CD20 IgG mg/m B 53.6% 69 CR14 PR % 21 PR % 16 PR6 B 3 6 IgA IgM IgG 2 38

39 ( ) ( ) ( ) 1 375mg/m 2 1 CD20 B CD20 CD20 B 1 375mg/m

40 ) TSE EMEA Committee for Proprietary Medicinal Products CPMP Committee for Veterinary Medical Products CVMP CPMP-CVMP Note for Guidance on minimizing the risk of transmitting animal spongiform encephelopathy agents via human and veterinary medicinal products EMEA/410/01 eu.int/pdfs /vet/ regaffair /041001en.pdf BSE BSE 40

41 BSE TSE TSE validation test (i) (ii) J Virol 74: 320,

42 (iii) (iv) BSE validation test validation test TSE Genentech 42

43 TSE CD20 B 2) 43

44 ) B 4) CD20 CD20 CD20 CD20 5) 1 375mg/m 2 44

45 6) ( ) infusion reaction infusion reaction 2 infusion reaction infusion -associated symptom infusion-related reactions infusion reaction 7) 24 infusion reaction infusion reaction 1,000 infusion reaction 45

46 8) CD20 B 1 375mg/m

47

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