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2 cladribine 2-CdA ADA DCF HCL IFN- MTD LD50 LD90 DLT MDACC RWJPRI NHL ATL CLL 2-CdATP 5 -NT dckase (2-chloro-2 -deoxyadenosine) adenosine deaminase deoxycoformycin( ) hairy cell leukemia - (interferon alfa) (maximum tolerated dose) 50%90% dose-limiting toxicity University of Texas M.D. Anderson Cancer Center R.W. Johnson Pharmaceutical Research Institute (non-hodgkin s lymphoma) T (adult T-cell leukemia/lymphoma) (chronic lymphocytic leukemia) 2-chloro-2 -deoxyadenosine triphosphate 5 -nucleotidase deoxycytidine kinase
3 1 1 (1) 1 1) HCL 1 2) 3 (2) 5 1) 5 2) 6 3) 7 (3) 9 1) 9 2) 12 3) 14 4) NHL, ATL (1) 18 (2) (1) JAN 29 (2) INN 29 (3)
4 1 (1) 2 adenosine deaminase adenosine ADA DNA 1) CLL10 NH 2 N N Cl N N 2-chloro-2 -deoxy- -D-adenosine HO O cladribine H C10H12ClN5O3 H H OH 1) HCL HCL B hairy appearance hairy cell HCL Bouroncle 2) HCL 2 3) ) 1) Seto S. et al.: Mechanism of deoxyadenosine and 2-chlorodeoxyadenosine toxicity to nondividing human lymphocytes. J Clin. Invest. 75: , ) Bouroncle. B.A. et al.: Leukemic reticuloendotheliosis. Blood 13: , ) Catovsky D. et al.: The Lymphoid Leukemias. Butterworths, London, pp , ) Cheson B.D. et al.: Clinical trials in hairy cell leukemia. Current status and future directions. Ann. Med. 106: ,
5 ) HCL HCL ) : HCL HCL 300,000/µL ) 6) Cawley 7) Catovsky 8) prolymphocytic variant HCL 30,000/L 6) Japanese variant Japanese variant HCL in vitro HCL HCL HCL HCL ) Hairy cell leukemia, :, 19.,, pp , ) Hairy Cell Leukemia. 22: , ) Cawley J.C. et al.: A chronic lymphoproliferative disorder with distinctive features:a distinct variant of hairy-cell leukaemia. Leuk. Res. 4: , ) Catovsky D: Prolymphocytic and hairy cell leukemias. in Henderson ES, Lister TA(eds): Leukemia. 5 th ed. WB Saunders, Philadelphia, pp ,
6 IFN-HCL 9)10) 1991 IFN- HCL (CR) IU/m ) 1994 deoxycoformycin(dcf HCL 4 mg/m ) 2) Southern Research Institute(SRI) Montogomery ADA 12) Christensen ) Scripps Clinic and Research FoundationScripps Carson ADA deoxyadenosine 14) 15) ADA ADA ADA deoxyadenosine analog 2 Carson Christensen 9) Saven A. et al.: Treatment of Hairy Cell Leukemia. Blood 79: , ) Golomb H.M. et al.: The treatment of hairy cell leukemia; an update. Leukemia 6:24-27, ) hairy cell leukemia (HCL). :,,, pp , ) Montgomery J.A. et al.: Synthesis of Potential Anticancer Agents. XX. 2-Fluoropurines. J. Ame. Chem. Soc. 82: , ) Christensen L.F. et al.: Synthesis and Biological Activity of Selected 2,6-Disubstituted-(2-deoxy- -and- -D-erythro-pentofuranosyl)purines. J. Med.Chem. 15(7): , ) Giblett E.R. et al.: Adenosine deaminase deficiency in two patients with severely impaired cellular immunity. Lancet 2: , ) Carson D.A. et al.: Lymphospecific toxicity in adenosine deaminase deficiency and purine nucleoside phosphorylase deficiency.:possible role of nucleoside kinase(s) Proc. Natl. Acad. Sci. USA 74: ,
7 deoxyadenosine analog ADA T screening 13 16) deoxycitidine kinasedckase 5 -nucleotidase5 - NT 17) CLL HCL 16) Carson D.A. et al.: Deoxycytidine kinase-mediated toxicity of deoxyadenosine analogs toward malignant human lymphoblasts in vitro and toward murine L1210 leukemia in vivo. Proc. Natl. Acad. Sci. USA 77: , ) Carson D.A. et al.: Specific toxicity of 2-chlorodeoxyadenosine toward resting and proliferating human lymphocytes. Blood 62: ,
8 (2) Scripps ) dckase 5 - dckase 5 - NT dckase 5 -NT dckase 5 -NT DNA DNA ribonucleotide reductase DNA polymerase DNA DNA DNA poly(adp-ribose)polymerase ATP NAD 1 7 L (MTD 50%LD50 90%LD mg/kg 150 mg/kg 180 mg/kg 5 50 mg/kg 75 mg/kg 100 mg/kg 1 mg/kg mg/kg 2 7 / CLL HCL - 5 -
9 Scripps 2) IND in vitro in vivo LD50 1/ mg/kg/ 4 Acute Nonlymphocytic Leukemia 0.09mg/kg/ mg/kg/ 0.09mg/kg/ mg/kg/ mg/kg/ mg/kg/ 0.13mg/kg/ 0.26mg/kg/ 9 6 T in blastic crisis DLT dose limiting toxicity: DLT mg/kg - 6 -
10 3) HCL mg/kg CR HCL 0.09mg/kg/ 7 HCL HCL Scripps HCL 77 University of Texas M.D. Anderson Cancer Center ( MDACC)HCL 7 1 Scripps Clinic 0.09 mg/kg MDACC 3.6 mg/m 2 Scripps MDACC % 70 CR CR IFN % CR 2 20,700 37,400/µL Japanese variant 2 CR 71.8% % 7.3%2 1 <500/µL <8.5 g/dl <20,000/µL 68.5% 41.1% 14.5% CD4 2 20%49.2%30.6% 29.0%23.4% 22.6% - 7 -
11 R.W. Johnson Pharmaceutical Research Institute ( RWJPRI) Scripps HCL CLL RWJPRI Scripps IND HCL NDA (NDA ) FDA mg/kg/ 7-8 -
12 (3) B-cell line -cell line T HTLV-I T ATL HCL NHL HCL ATL (7 A) 73 1) 14 (0.09 mg/kg/ ) 0.1 mg/kg/ mg/kg/ 0.6 mg/kg/ [ ] (0.5, mg/kg/, ) 1.5 mg/kg/3.0 mg/kg/ (0.3, mg/kg/, ) 3.0 mg/kg/ (1.0 mg/ml) 0.1 mg/kg HCL 0.09 mg/kg/ RWJPRI HCL CLL - 9 -
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14 T 0.09 mg/kg/ ( ) 18) 0.09 mg/kg/ 7 2/ mg/kg/ 7 3 GLP P388 L1210 T LM-2 B LM mg/kg 100 in vitro 100 g/ml 5 mg/kg mg/kg/ 20mg/kg/ 0.09 mg/kg/ 0.1 mg/kg/ mg/kg/ ) FIRST ANNUAL UPDATE ON LEUSTATIN TM (CLADRIBINE) FOR THE TREATMENT OF HAIRY CELL LEUKEMIA, R.W. Johnson Pharmaceutical Research Institute
15 mg/kg/ 6 Seg 30 mg/kg/ 1 8 mg/kg/ Seg 3.0 mg/kg/ 0.5 mg/kg/ 1.5 mg/kg/ 3 H % 10% 98% % 3 H % 2)
16 0.09 mg/kg/ 2/ mg/kg/ 0.03 mg/kg 0.09 mg/kg/ 0.06 mg/kg/3 critical toxicity grade 4 grade mg/kg/ mg/kg/ 3 critical toxicity HCL 19) Purine nucleoside NCI 20) mg/kg/( ) HCL HCL purine nucleoside 血中濃度 (ng/ml) Day 1 Day 2 Day 3 Day 4 Day 5 Day 6 Day 7 投与後経過日数 ( 日 ) 図イ mg/kg/ 日投与時の血中未変化体濃度比較 ( 国内 - 海外 ) 国内 Mean 国内 +SD 国内 SD 海外 Mean 海外 +SD 海外 SD 19) Hoffman M, et al.: 2-Chlorodeoxyadenosine is an active salvage therapy in advanced indolent non- Hodgkin s lymphoma. J. Clin. Oncol. 12(4): , ) Cheson B.D., et al. : Neurotoxicity of purine analogs : A review. J.Clin.Oncol.12 (10): ,
17 0.09 mg/kg/ 6 3 NHL ATL CLL critical toxicity grade 4 grade 3 grade mg/kg/ 0.06 mg/kg/0.09 mg/kg/ 2 Cmax Css AUC t1/ mg/kg/ 7 48 ( 216 ) 2-chloroadenine % 2- chloroadenine % 2-chloroadenine % 38 % HCL NHL ATL NHL indolent NHL aggressive NHL indolent NHL 3) HCL mg/kg/ 7 1 PR 2 HCL HCL 10 7 CR5 PR HCL
18 IFN HCL HCL HCL 7 6 prolymphocytic variant Japanese variant HCL 2 Japanese variant Japanese variant CR 10 grade G-CSF Grade 4 1 4) NHL ATL HCL ATL grade NHL [ ] 0.09mg/kg / (grade 3 )
19 PS GPT 0.09mg/kg 7 HCL indolent NHL Company Core Data Sheet CCDS 8mg mg/kg 7 1 HCL HCL HCL HCL HCL HCL Japanese variant 70.0 CR 50.0CR IFN
20 HCL Japanese variant HCL IFN
21 2 (1) 1) in vitro CEM ( p173) B LM-3 BALB/cA-nu ( p176) 2) 2 1 ( p178) 3) cytosine arabinoside ( p182) HCL CLL 4) dckase 5 -NT dckase ( p182) 5) ADA ADA DNA DNA ribonucleotide reductase DNA polymerase DNA DNA DNA poly(adp-ribose)polymerase ATP NAD ( p186)
22 (2) 1) CR % CR 50.0% 7/10 CR 5 PR 2 90% % ( p248) % CR 66.0% 93/106 CR 70 PR 23 p309 2) CR PR CR 5 CR p252 3) 10 IFN- 2 IFN- 1 CR p248 IFN % 4 75 p312 4) 10 grade G-CSF PS 2 1 p
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24 HCL 3 HCL CLL NCI PDQ IFN / /
25 4 LEUSTATIN ( ) LEUSTATIN( ) ( 4~9 ) ( ) ( 4~9 ) 0.09 mg/kg/ ( ) ( ) 1 (0.09 mg/kg 0.09 ml/kg) 0.9% (USP)500 ml %
26 4 0.9% (USP)(0.9% ) 0.22 µ (0.09 mg/kg(ml/kg)7 ) 0.9% (USP)(0.9% ) 100 ml 7 ( ) (2 ~8 C)8 1 ( ) () 2 ( ) 1 44%14% 4~8( ) 1 2/3(131/196) >100ºF 47%(93/196) (<1000) 62 (32%)(<500)
27 4 (4~9 ) (29 )(2 ) 31 7~14 8 7~136 (19%) ( ) (35%) ( ) () ( 4 ) axonal peripheral polyneuropathy (0.09 mg/kg/ 7) ( 3) gasping syndrome ( ) D DNA( )
28 4 ( 4~8 ) ( ) % 1/3 ( ) ( ) tumor lysis syndrome ( ) x 10 9 /L x 10 6 /L 812 g/dl ( )
29 4 DNA DNA DNAIn vitro ( ) DNAin vitro( ) in vivo( ) () D( ) (1~21 ) 3~10.7 mg/m 2 / 5 ( 1/2~2 ) (10.7 mg/m2/ )7 3 (1)( ) 196 ( ) 1 70%69% 28% 14(45%) (28%) (27%) (22%) (19%) 1(<500 x 10 6 /L) 70% (26%) ( <8.5 g/dl) 37%( 10%) (<20 x 10 9 /L) 12%( 4%)
30 (28%) ( ) 6% 2 6% 3 1(>104 F) 11% 1/ (42%) 11 (20%)11 (20%) ( ) CD4 CD4766/µL 4~6 ( 272/µL)15 500/µL CD89 CD4 2 cellularity <35% (34%) ( ) 2 5% ( ) (69%)(45%) (9%)(9%) (9%) (7%)(6%) (28%)(17%) (13%) (10%) (9%) (6%) (10%)(8%)(5%) (22%)(9%) (7%)
31 4 (6%) (6%) (11%) (10%)(9%)(7%) (27%) (19%)(6%) (6%) (6%) (7%)(5%) (9%)( ) (2%)(2%) (1%) 15 5% (11%) (10%) (7%) (7%)(5%) ( ) ( ) ( ) ( ) ( [ ] ) ( ) () ( )
32 5 (1) ) cladribine chloro-2 -deoxyadenosine (2) 21) cladribine 2-chloro-2 -deoxyadenosine (3) NH 2 N N Cl N N HO O H H H OH 21 rec. INN List 33, WHO Drug Information Vol.7 No.3,
33 6 HCL HCL
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