Ponatinib in Japanese patients with Philadelphia chromosome-positive leukemia, a phase 1/2 study
Abstract In this ongoing Phase 1/2 study (NCT01667133), we evaluated ponatinib and assessed its recommended dose in Japanese patients with chronic myeloid leukemia (CML) resistant/intolerant to dasatinib or nilotinib, or with Philadelphia chromosome–positive acute lymphoblastic leukemia ($ Ph^{+} $A...
Ausführliche Beschreibung
Gespeichert in:
| Autor*in: |
Tojo, Arinobu [verfasserIn] |
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| Format: |
E-Artikel |
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| Sprache: |
Englisch |
| Erschienen: |
2017 |
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| Schlagwörter: |
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| Anmerkung: |
© The Japanese Society of Hematology 2017 |
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| Übergeordnetes Werk: |
Enthalten in: International journal of hematology - Tokyo [u.a.] : Springer, 1995, 106(2017), 3 vom: 25. Apr., Seite 385-397 |
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| Übergeordnetes Werk: |
volume:106 ; year:2017 ; number:3 ; day:25 ; month:04 ; pages:385-397 |
| Links: |
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| DOI / URN: |
10.1007/s12185-017-2238-9 |
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| Katalog-ID: |
SPR025123610 |
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| 100 | 1 | |a Tojo, Arinobu |e verfasserin |0 (orcid)0000-0001-9016-1948 |4 aut | |
| 245 | 1 | 0 | |a Ponatinib in Japanese patients with Philadelphia chromosome-positive leukemia, a phase 1/2 study |
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| 520 | |a Abstract In this ongoing Phase 1/2 study (NCT01667133), we evaluated ponatinib and assessed its recommended dose in Japanese patients with chronic myeloid leukemia (CML) resistant/intolerant to dasatinib or nilotinib, or with Philadelphia chromosome–positive acute lymphoblastic leukemia ($ Ph^{+} $ALL) resistant/intolerant to ≥1 tyrosine kinase inhibitor (TKI). The primary endpoints were safety of the recommended dose (Phase 1) and major cytogenetic response (MCyR) by 12 months in chronic-phase CML (CP-CML) patients or major hematologic response (MaHR) by 6 months in patients with advanced phase disease (Phase 2). MCyR was achieved/maintained by 12 months in 65% of CP-CML patients; MaHR was achieved by 6 months in 61% of patients with advanced phase disease. The most common nonhematologic grade 3/4 treatment-emergent adverse event (AE) was hypertension (37%); common hematologic grade 3/4 AEs were thrombocytopenia (57%), neutropenia (34%), and leukopenia (26%). Overall, five (14%) patients experienced arterial occlusive events (AOEs); no grade 5 AOEs were reported. The steady-state accumulation ratio of ponatinib (based on area under the curve) ranged from 2.6 (15 mg/day) to 1.3 (45 mg/day). In summary, ponatinib demonstrated efficacy in Japanese patients with CML and $ Ph^{+} $ALL resistant/intolerant to prior TKI treatment; safety data support a recommended starting dose of 45 mg/day in these patients. | ||
| 650 | 4 | |a Ponatinib |7 (dpeaa)DE-He213 | |
| 650 | 4 | |a CML |7 (dpeaa)DE-He213 | |
| 650 | 4 | |a Japanese population |7 (dpeaa)DE-He213 | |
| 650 | 4 | |a Ph+ALL |7 (dpeaa)DE-He213 | |
| 650 | 4 | |a Phase 1/2 |7 (dpeaa)DE-He213 | |
| 700 | 1 | |a Kyo, Taiichi |4 aut | |
| 700 | 1 | |a Yamamoto, Kazuhito |4 aut | |
| 700 | 1 | |a Nakamae, Hirohisa |4 aut | |
| 700 | 1 | |a Takahashi, Naoto |4 aut | |
| 700 | 1 | |a Kobayashi, Yukio |4 aut | |
| 700 | 1 | |a Tauchi, Tetsuzo |4 aut | |
| 700 | 1 | |a Okamoto, Shinichiro |4 aut | |
| 700 | 1 | |a Miyamura, Koichi |4 aut | |
| 700 | 1 | |a Hatake, Kiyohiko |4 aut | |
| 700 | 1 | |a Iwasaki, Hiromi |4 aut | |
| 700 | 1 | |a Matsumura, Itaru |4 aut | |
| 700 | 1 | |a Usui, Noriko |4 aut | |
| 700 | 1 | |a Naoe, Tomoki |4 aut | |
| 700 | 1 | |a Tugnait, Meera |4 aut | |
| 700 | 1 | |a Narasimhan, Narayana I. |4 aut | |
| 700 | 1 | |a Lustgarten, Stephanie |4 aut | |
| 700 | 1 | |a Farin, Heinrich |4 aut | |
| 700 | 1 | |a Haluska, Frank |4 aut | |
| 700 | 1 | |a Ohyashiki, Kazuma |4 aut | |
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10.1007/s12185-017-2238-9 doi (DE-627)SPR025123610 (SPR)s12185-017-2238-9-e DE-627 ger DE-627 rakwb eng Tojo, Arinobu verfasserin (orcid)0000-0001-9016-1948 aut Ponatinib in Japanese patients with Philadelphia chromosome-positive leukemia, a phase 1/2 study 2017 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Japanese Society of Hematology 2017 Abstract In this ongoing Phase 1/2 study (NCT01667133), we evaluated ponatinib and assessed its recommended dose in Japanese patients with chronic myeloid leukemia (CML) resistant/intolerant to dasatinib or nilotinib, or with Philadelphia chromosome–positive acute lymphoblastic leukemia ($ Ph^{+} $ALL) resistant/intolerant to ≥1 tyrosine kinase inhibitor (TKI). The primary endpoints were safety of the recommended dose (Phase 1) and major cytogenetic response (MCyR) by 12 months in chronic-phase CML (CP-CML) patients or major hematologic response (MaHR) by 6 months in patients with advanced phase disease (Phase 2). MCyR was achieved/maintained by 12 months in 65% of CP-CML patients; MaHR was achieved by 6 months in 61% of patients with advanced phase disease. The most common nonhematologic grade 3/4 treatment-emergent adverse event (AE) was hypertension (37%); common hematologic grade 3/4 AEs were thrombocytopenia (57%), neutropenia (34%), and leukopenia (26%). Overall, five (14%) patients experienced arterial occlusive events (AOEs); no grade 5 AOEs were reported. The steady-state accumulation ratio of ponatinib (based on area under the curve) ranged from 2.6 (15 mg/day) to 1.3 (45 mg/day). In summary, ponatinib demonstrated efficacy in Japanese patients with CML and $ Ph^{+} $ALL resistant/intolerant to prior TKI treatment; safety data support a recommended starting dose of 45 mg/day in these patients. Ponatinib (dpeaa)DE-He213 CML (dpeaa)DE-He213 Japanese population (dpeaa)DE-He213 Ph+ALL (dpeaa)DE-He213 Phase 1/2 (dpeaa)DE-He213 Kyo, Taiichi aut Yamamoto, Kazuhito aut Nakamae, Hirohisa aut Takahashi, Naoto aut Kobayashi, Yukio aut Tauchi, Tetsuzo aut Okamoto, Shinichiro aut Miyamura, Koichi aut Hatake, Kiyohiko aut Iwasaki, Hiromi aut Matsumura, Itaru aut Usui, Noriko aut Naoe, Tomoki aut Tugnait, Meera aut Narasimhan, Narayana I. aut Lustgarten, Stephanie aut Farin, Heinrich aut Haluska, Frank aut Ohyashiki, Kazuma aut Enthalten in International journal of hematology Tokyo [u.a.] : Springer, 1995 106(2017), 3 vom: 25. Apr., Seite 385-397 (DE-627)324615485 (DE-600)2028991-1 1865-3774 nnns volume:106 year:2017 number:3 day:25 month:04 pages:385-397 https://dx.doi.org/10.1007/s12185-017-2238-9 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_120 GBV_ILN_138 GBV_ILN_150 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_187 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_250 GBV_ILN_281 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_636 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2031 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2039 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2070 GBV_ILN_2086 GBV_ILN_2088 GBV_ILN_2093 GBV_ILN_2106 GBV_ILN_2107 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2116 GBV_ILN_2118 GBV_ILN_2119 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2188 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2446 GBV_ILN_2470 GBV_ILN_2472 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_2548 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4246 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 AR 106 2017 3 25 04 385-397 |
| spelling |
10.1007/s12185-017-2238-9 doi (DE-627)SPR025123610 (SPR)s12185-017-2238-9-e DE-627 ger DE-627 rakwb eng Tojo, Arinobu verfasserin (orcid)0000-0001-9016-1948 aut Ponatinib in Japanese patients with Philadelphia chromosome-positive leukemia, a phase 1/2 study 2017 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Japanese Society of Hematology 2017 Abstract In this ongoing Phase 1/2 study (NCT01667133), we evaluated ponatinib and assessed its recommended dose in Japanese patients with chronic myeloid leukemia (CML) resistant/intolerant to dasatinib or nilotinib, or with Philadelphia chromosome–positive acute lymphoblastic leukemia ($ Ph^{+} $ALL) resistant/intolerant to ≥1 tyrosine kinase inhibitor (TKI). The primary endpoints were safety of the recommended dose (Phase 1) and major cytogenetic response (MCyR) by 12 months in chronic-phase CML (CP-CML) patients or major hematologic response (MaHR) by 6 months in patients with advanced phase disease (Phase 2). MCyR was achieved/maintained by 12 months in 65% of CP-CML patients; MaHR was achieved by 6 months in 61% of patients with advanced phase disease. The most common nonhematologic grade 3/4 treatment-emergent adverse event (AE) was hypertension (37%); common hematologic grade 3/4 AEs were thrombocytopenia (57%), neutropenia (34%), and leukopenia (26%). Overall, five (14%) patients experienced arterial occlusive events (AOEs); no grade 5 AOEs were reported. The steady-state accumulation ratio of ponatinib (based on area under the curve) ranged from 2.6 (15 mg/day) to 1.3 (45 mg/day). In summary, ponatinib demonstrated efficacy in Japanese patients with CML and $ Ph^{+} $ALL resistant/intolerant to prior TKI treatment; safety data support a recommended starting dose of 45 mg/day in these patients. Ponatinib (dpeaa)DE-He213 CML (dpeaa)DE-He213 Japanese population (dpeaa)DE-He213 Ph+ALL (dpeaa)DE-He213 Phase 1/2 (dpeaa)DE-He213 Kyo, Taiichi aut Yamamoto, Kazuhito aut Nakamae, Hirohisa aut Takahashi, Naoto aut Kobayashi, Yukio aut Tauchi, Tetsuzo aut Okamoto, Shinichiro aut Miyamura, Koichi aut Hatake, Kiyohiko aut Iwasaki, Hiromi aut Matsumura, Itaru aut Usui, Noriko aut Naoe, Tomoki aut Tugnait, Meera aut Narasimhan, Narayana I. aut Lustgarten, Stephanie aut Farin, Heinrich aut Haluska, Frank aut Ohyashiki, Kazuma aut Enthalten in International journal of hematology Tokyo [u.a.] : Springer, 1995 106(2017), 3 vom: 25. Apr., Seite 385-397 (DE-627)324615485 (DE-600)2028991-1 1865-3774 nnns volume:106 year:2017 number:3 day:25 month:04 pages:385-397 https://dx.doi.org/10.1007/s12185-017-2238-9 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_120 GBV_ILN_138 GBV_ILN_150 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_187 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_250 GBV_ILN_281 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_636 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2031 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2039 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2070 GBV_ILN_2086 GBV_ILN_2088 GBV_ILN_2093 GBV_ILN_2106 GBV_ILN_2107 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2116 GBV_ILN_2118 GBV_ILN_2119 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2188 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2446 GBV_ILN_2470 GBV_ILN_2472 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_2548 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4246 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 AR 106 2017 3 25 04 385-397 |
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10.1007/s12185-017-2238-9 doi (DE-627)SPR025123610 (SPR)s12185-017-2238-9-e DE-627 ger DE-627 rakwb eng Tojo, Arinobu verfasserin (orcid)0000-0001-9016-1948 aut Ponatinib in Japanese patients with Philadelphia chromosome-positive leukemia, a phase 1/2 study 2017 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Japanese Society of Hematology 2017 Abstract In this ongoing Phase 1/2 study (NCT01667133), we evaluated ponatinib and assessed its recommended dose in Japanese patients with chronic myeloid leukemia (CML) resistant/intolerant to dasatinib or nilotinib, or with Philadelphia chromosome–positive acute lymphoblastic leukemia ($ Ph^{+} $ALL) resistant/intolerant to ≥1 tyrosine kinase inhibitor (TKI). The primary endpoints were safety of the recommended dose (Phase 1) and major cytogenetic response (MCyR) by 12 months in chronic-phase CML (CP-CML) patients or major hematologic response (MaHR) by 6 months in patients with advanced phase disease (Phase 2). MCyR was achieved/maintained by 12 months in 65% of CP-CML patients; MaHR was achieved by 6 months in 61% of patients with advanced phase disease. The most common nonhematologic grade 3/4 treatment-emergent adverse event (AE) was hypertension (37%); common hematologic grade 3/4 AEs were thrombocytopenia (57%), neutropenia (34%), and leukopenia (26%). Overall, five (14%) patients experienced arterial occlusive events (AOEs); no grade 5 AOEs were reported. The steady-state accumulation ratio of ponatinib (based on area under the curve) ranged from 2.6 (15 mg/day) to 1.3 (45 mg/day). In summary, ponatinib demonstrated efficacy in Japanese patients with CML and $ Ph^{+} $ALL resistant/intolerant to prior TKI treatment; safety data support a recommended starting dose of 45 mg/day in these patients. Ponatinib (dpeaa)DE-He213 CML (dpeaa)DE-He213 Japanese population (dpeaa)DE-He213 Ph+ALL (dpeaa)DE-He213 Phase 1/2 (dpeaa)DE-He213 Kyo, Taiichi aut Yamamoto, Kazuhito aut Nakamae, Hirohisa aut Takahashi, Naoto aut Kobayashi, Yukio aut Tauchi, Tetsuzo aut Okamoto, Shinichiro aut Miyamura, Koichi aut Hatake, Kiyohiko aut Iwasaki, Hiromi aut Matsumura, Itaru aut Usui, Noriko aut Naoe, Tomoki aut Tugnait, Meera aut Narasimhan, Narayana I. aut Lustgarten, Stephanie aut Farin, Heinrich aut Haluska, Frank aut Ohyashiki, Kazuma aut Enthalten in International journal of hematology Tokyo [u.a.] : Springer, 1995 106(2017), 3 vom: 25. Apr., Seite 385-397 (DE-627)324615485 (DE-600)2028991-1 1865-3774 nnns volume:106 year:2017 number:3 day:25 month:04 pages:385-397 https://dx.doi.org/10.1007/s12185-017-2238-9 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_120 GBV_ILN_138 GBV_ILN_150 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_187 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_250 GBV_ILN_281 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_636 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2031 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2039 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2070 GBV_ILN_2086 GBV_ILN_2088 GBV_ILN_2093 GBV_ILN_2106 GBV_ILN_2107 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2116 GBV_ILN_2118 GBV_ILN_2119 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2188 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2446 GBV_ILN_2470 GBV_ILN_2472 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_2548 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4246 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 AR 106 2017 3 25 04 385-397 |
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10.1007/s12185-017-2238-9 doi (DE-627)SPR025123610 (SPR)s12185-017-2238-9-e DE-627 ger DE-627 rakwb eng Tojo, Arinobu verfasserin (orcid)0000-0001-9016-1948 aut Ponatinib in Japanese patients with Philadelphia chromosome-positive leukemia, a phase 1/2 study 2017 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Japanese Society of Hematology 2017 Abstract In this ongoing Phase 1/2 study (NCT01667133), we evaluated ponatinib and assessed its recommended dose in Japanese patients with chronic myeloid leukemia (CML) resistant/intolerant to dasatinib or nilotinib, or with Philadelphia chromosome–positive acute lymphoblastic leukemia ($ Ph^{+} $ALL) resistant/intolerant to ≥1 tyrosine kinase inhibitor (TKI). The primary endpoints were safety of the recommended dose (Phase 1) and major cytogenetic response (MCyR) by 12 months in chronic-phase CML (CP-CML) patients or major hematologic response (MaHR) by 6 months in patients with advanced phase disease (Phase 2). MCyR was achieved/maintained by 12 months in 65% of CP-CML patients; MaHR was achieved by 6 months in 61% of patients with advanced phase disease. The most common nonhematologic grade 3/4 treatment-emergent adverse event (AE) was hypertension (37%); common hematologic grade 3/4 AEs were thrombocytopenia (57%), neutropenia (34%), and leukopenia (26%). Overall, five (14%) patients experienced arterial occlusive events (AOEs); no grade 5 AOEs were reported. The steady-state accumulation ratio of ponatinib (based on area under the curve) ranged from 2.6 (15 mg/day) to 1.3 (45 mg/day). In summary, ponatinib demonstrated efficacy in Japanese patients with CML and $ Ph^{+} $ALL resistant/intolerant to prior TKI treatment; safety data support a recommended starting dose of 45 mg/day in these patients. Ponatinib (dpeaa)DE-He213 CML (dpeaa)DE-He213 Japanese population (dpeaa)DE-He213 Ph+ALL (dpeaa)DE-He213 Phase 1/2 (dpeaa)DE-He213 Kyo, Taiichi aut Yamamoto, Kazuhito aut Nakamae, Hirohisa aut Takahashi, Naoto aut Kobayashi, Yukio aut Tauchi, Tetsuzo aut Okamoto, Shinichiro aut Miyamura, Koichi aut Hatake, Kiyohiko aut Iwasaki, Hiromi aut Matsumura, Itaru aut Usui, Noriko aut Naoe, Tomoki aut Tugnait, Meera aut Narasimhan, Narayana I. aut Lustgarten, Stephanie aut Farin, Heinrich aut Haluska, Frank aut Ohyashiki, Kazuma aut Enthalten in International journal of hematology Tokyo [u.a.] : Springer, 1995 106(2017), 3 vom: 25. Apr., Seite 385-397 (DE-627)324615485 (DE-600)2028991-1 1865-3774 nnns volume:106 year:2017 number:3 day:25 month:04 pages:385-397 https://dx.doi.org/10.1007/s12185-017-2238-9 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_120 GBV_ILN_138 GBV_ILN_150 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_187 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_250 GBV_ILN_281 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_636 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2031 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2039 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2070 GBV_ILN_2086 GBV_ILN_2088 GBV_ILN_2093 GBV_ILN_2106 GBV_ILN_2107 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2116 GBV_ILN_2118 GBV_ILN_2119 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2188 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2446 GBV_ILN_2470 GBV_ILN_2472 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_2548 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4246 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 AR 106 2017 3 25 04 385-397 |
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10.1007/s12185-017-2238-9 doi (DE-627)SPR025123610 (SPR)s12185-017-2238-9-e DE-627 ger DE-627 rakwb eng Tojo, Arinobu verfasserin (orcid)0000-0001-9016-1948 aut Ponatinib in Japanese patients with Philadelphia chromosome-positive leukemia, a phase 1/2 study 2017 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Japanese Society of Hematology 2017 Abstract In this ongoing Phase 1/2 study (NCT01667133), we evaluated ponatinib and assessed its recommended dose in Japanese patients with chronic myeloid leukemia (CML) resistant/intolerant to dasatinib or nilotinib, or with Philadelphia chromosome–positive acute lymphoblastic leukemia ($ Ph^{+} $ALL) resistant/intolerant to ≥1 tyrosine kinase inhibitor (TKI). The primary endpoints were safety of the recommended dose (Phase 1) and major cytogenetic response (MCyR) by 12 months in chronic-phase CML (CP-CML) patients or major hematologic response (MaHR) by 6 months in patients with advanced phase disease (Phase 2). MCyR was achieved/maintained by 12 months in 65% of CP-CML patients; MaHR was achieved by 6 months in 61% of patients with advanced phase disease. The most common nonhematologic grade 3/4 treatment-emergent adverse event (AE) was hypertension (37%); common hematologic grade 3/4 AEs were thrombocytopenia (57%), neutropenia (34%), and leukopenia (26%). Overall, five (14%) patients experienced arterial occlusive events (AOEs); no grade 5 AOEs were reported. The steady-state accumulation ratio of ponatinib (based on area under the curve) ranged from 2.6 (15 mg/day) to 1.3 (45 mg/day). In summary, ponatinib demonstrated efficacy in Japanese patients with CML and $ Ph^{+} $ALL resistant/intolerant to prior TKI treatment; safety data support a recommended starting dose of 45 mg/day in these patients. Ponatinib (dpeaa)DE-He213 CML (dpeaa)DE-He213 Japanese population (dpeaa)DE-He213 Ph+ALL (dpeaa)DE-He213 Phase 1/2 (dpeaa)DE-He213 Kyo, Taiichi aut Yamamoto, Kazuhito aut Nakamae, Hirohisa aut Takahashi, Naoto aut Kobayashi, Yukio aut Tauchi, Tetsuzo aut Okamoto, Shinichiro aut Miyamura, Koichi aut Hatake, Kiyohiko aut Iwasaki, Hiromi aut Matsumura, Itaru aut Usui, Noriko aut Naoe, Tomoki aut Tugnait, Meera aut Narasimhan, Narayana I. aut Lustgarten, Stephanie aut Farin, Heinrich aut Haluska, Frank aut Ohyashiki, Kazuma aut Enthalten in International journal of hematology Tokyo [u.a.] : Springer, 1995 106(2017), 3 vom: 25. Apr., Seite 385-397 (DE-627)324615485 (DE-600)2028991-1 1865-3774 nnns volume:106 year:2017 number:3 day:25 month:04 pages:385-397 https://dx.doi.org/10.1007/s12185-017-2238-9 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_120 GBV_ILN_138 GBV_ILN_150 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_187 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_250 GBV_ILN_281 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_636 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2031 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2039 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2070 GBV_ILN_2086 GBV_ILN_2088 GBV_ILN_2093 GBV_ILN_2106 GBV_ILN_2107 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2116 GBV_ILN_2118 GBV_ILN_2119 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2188 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2446 GBV_ILN_2470 GBV_ILN_2472 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_2548 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4246 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 AR 106 2017 3 25 04 385-397 |
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Enthalten in International journal of hematology 106(2017), 3 vom: 25. Apr., Seite 385-397 volume:106 year:2017 number:3 day:25 month:04 pages:385-397 |
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Enthalten in International journal of hematology 106(2017), 3 vom: 25. Apr., Seite 385-397 volume:106 year:2017 number:3 day:25 month:04 pages:385-397 |
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Tojo, Arinobu @@aut@@ Kyo, Taiichi @@aut@@ Yamamoto, Kazuhito @@aut@@ Nakamae, Hirohisa @@aut@@ Takahashi, Naoto @@aut@@ Kobayashi, Yukio @@aut@@ Tauchi, Tetsuzo @@aut@@ Okamoto, Shinichiro @@aut@@ Miyamura, Koichi @@aut@@ Hatake, Kiyohiko @@aut@@ Iwasaki, Hiromi @@aut@@ Matsumura, Itaru @@aut@@ Usui, Noriko @@aut@@ Naoe, Tomoki @@aut@@ Tugnait, Meera @@aut@@ Narasimhan, Narayana I. @@aut@@ Lustgarten, Stephanie @@aut@@ Farin, Heinrich @@aut@@ Haluska, Frank @@aut@@ Ohyashiki, Kazuma @@aut@@ |
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The primary endpoints were safety of the recommended dose (Phase 1) and major cytogenetic response (MCyR) by 12 months in chronic-phase CML (CP-CML) patients or major hematologic response (MaHR) by 6 months in patients with advanced phase disease (Phase 2). MCyR was achieved/maintained by 12 months in 65% of CP-CML patients; MaHR was achieved by 6 months in 61% of patients with advanced phase disease. The most common nonhematologic grade 3/4 treatment-emergent adverse event (AE) was hypertension (37%); common hematologic grade 3/4 AEs were thrombocytopenia (57%), neutropenia (34%), and leukopenia (26%). Overall, five (14%) patients experienced arterial occlusive events (AOEs); no grade 5 AOEs were reported. The steady-state accumulation ratio of ponatinib (based on area under the curve) ranged from 2.6 (15 mg/day) to 1.3 (45 mg/day). 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Tojo, Arinobu |
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Tojo, Arinobu misc Ponatinib misc CML misc Japanese population misc Ph+ALL misc Phase 1/2 Ponatinib in Japanese patients with Philadelphia chromosome-positive leukemia, a phase 1/2 study |
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Ponatinib in Japanese patients with Philadelphia chromosome-positive leukemia, a phase 1/2 study Ponatinib (dpeaa)DE-He213 CML (dpeaa)DE-He213 Japanese population (dpeaa)DE-He213 Ph+ALL (dpeaa)DE-He213 Phase 1/2 (dpeaa)DE-He213 |
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Tojo, Arinobu Kyo, Taiichi Yamamoto, Kazuhito Nakamae, Hirohisa Takahashi, Naoto Kobayashi, Yukio Tauchi, Tetsuzo Okamoto, Shinichiro Miyamura, Koichi Hatake, Kiyohiko Iwasaki, Hiromi Matsumura, Itaru Usui, Noriko Naoe, Tomoki Tugnait, Meera Narasimhan, Narayana I. Lustgarten, Stephanie Farin, Heinrich Haluska, Frank Ohyashiki, Kazuma |
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ponatinib in japanese patients with philadelphia chromosome-positive leukemia, a phase 1/2 study |
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Ponatinib in Japanese patients with Philadelphia chromosome-positive leukemia, a phase 1/2 study |
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Abstract In this ongoing Phase 1/2 study (NCT01667133), we evaluated ponatinib and assessed its recommended dose in Japanese patients with chronic myeloid leukemia (CML) resistant/intolerant to dasatinib or nilotinib, or with Philadelphia chromosome–positive acute lymphoblastic leukemia ($ Ph^{+} $ALL) resistant/intolerant to ≥1 tyrosine kinase inhibitor (TKI). The primary endpoints were safety of the recommended dose (Phase 1) and major cytogenetic response (MCyR) by 12 months in chronic-phase CML (CP-CML) patients or major hematologic response (MaHR) by 6 months in patients with advanced phase disease (Phase 2). MCyR was achieved/maintained by 12 months in 65% of CP-CML patients; MaHR was achieved by 6 months in 61% of patients with advanced phase disease. The most common nonhematologic grade 3/4 treatment-emergent adverse event (AE) was hypertension (37%); common hematologic grade 3/4 AEs were thrombocytopenia (57%), neutropenia (34%), and leukopenia (26%). Overall, five (14%) patients experienced arterial occlusive events (AOEs); no grade 5 AOEs were reported. The steady-state accumulation ratio of ponatinib (based on area under the curve) ranged from 2.6 (15 mg/day) to 1.3 (45 mg/day). In summary, ponatinib demonstrated efficacy in Japanese patients with CML and $ Ph^{+} $ALL resistant/intolerant to prior TKI treatment; safety data support a recommended starting dose of 45 mg/day in these patients. © The Japanese Society of Hematology 2017 |
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Abstract In this ongoing Phase 1/2 study (NCT01667133), we evaluated ponatinib and assessed its recommended dose in Japanese patients with chronic myeloid leukemia (CML) resistant/intolerant to dasatinib or nilotinib, or with Philadelphia chromosome–positive acute lymphoblastic leukemia ($ Ph^{+} $ALL) resistant/intolerant to ≥1 tyrosine kinase inhibitor (TKI). The primary endpoints were safety of the recommended dose (Phase 1) and major cytogenetic response (MCyR) by 12 months in chronic-phase CML (CP-CML) patients or major hematologic response (MaHR) by 6 months in patients with advanced phase disease (Phase 2). MCyR was achieved/maintained by 12 months in 65% of CP-CML patients; MaHR was achieved by 6 months in 61% of patients with advanced phase disease. The most common nonhematologic grade 3/4 treatment-emergent adverse event (AE) was hypertension (37%); common hematologic grade 3/4 AEs were thrombocytopenia (57%), neutropenia (34%), and leukopenia (26%). Overall, five (14%) patients experienced arterial occlusive events (AOEs); no grade 5 AOEs were reported. The steady-state accumulation ratio of ponatinib (based on area under the curve) ranged from 2.6 (15 mg/day) to 1.3 (45 mg/day). In summary, ponatinib demonstrated efficacy in Japanese patients with CML and $ Ph^{+} $ALL resistant/intolerant to prior TKI treatment; safety data support a recommended starting dose of 45 mg/day in these patients. © The Japanese Society of Hematology 2017 |
| abstract_unstemmed |
Abstract In this ongoing Phase 1/2 study (NCT01667133), we evaluated ponatinib and assessed its recommended dose in Japanese patients with chronic myeloid leukemia (CML) resistant/intolerant to dasatinib or nilotinib, or with Philadelphia chromosome–positive acute lymphoblastic leukemia ($ Ph^{+} $ALL) resistant/intolerant to ≥1 tyrosine kinase inhibitor (TKI). The primary endpoints were safety of the recommended dose (Phase 1) and major cytogenetic response (MCyR) by 12 months in chronic-phase CML (CP-CML) patients or major hematologic response (MaHR) by 6 months in patients with advanced phase disease (Phase 2). MCyR was achieved/maintained by 12 months in 65% of CP-CML patients; MaHR was achieved by 6 months in 61% of patients with advanced phase disease. The most common nonhematologic grade 3/4 treatment-emergent adverse event (AE) was hypertension (37%); common hematologic grade 3/4 AEs were thrombocytopenia (57%), neutropenia (34%), and leukopenia (26%). Overall, five (14%) patients experienced arterial occlusive events (AOEs); no grade 5 AOEs were reported. The steady-state accumulation ratio of ponatinib (based on area under the curve) ranged from 2.6 (15 mg/day) to 1.3 (45 mg/day). In summary, ponatinib demonstrated efficacy in Japanese patients with CML and $ Ph^{+} $ALL resistant/intolerant to prior TKI treatment; safety data support a recommended starting dose of 45 mg/day in these patients. © The Japanese Society of Hematology 2017 |
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| score |
7.3993473 |