Special Drug Use-results Surveillance of Scemblix Tablets

Chronic Myeloid Leukemia Clinical Trial

Official title:

Special Drug Use-results Surveillance of Scemblix Tablets (Resistant or Intolerant Chronic Myeloid Leukemia , CABL001A1401)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05421091
• Other study ID #: CABL001A1401
• Status: Completed
• Start date: July 4, 2022
• Est. completion date: February 29, 2024

Study information

• Verified date: March 2024
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Uncontrolled, central registration system, all-case, multicenter, special drug use-results surveillance.

Description:

The objective of this study is to collect data on the occurrence, severity, clinical courses of the safety specifications of asciminib, identify factors etc. involved in occurrence and assess its clinical safety inresistant/intolerant chronic myelogenous leukemia patients during an observational period of 48 weeks from the start of treatment with asciminib.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 550
• Est. completion date: February 29, 2024
• Est. primary completion date: February 29, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 99 Years

Eligibility

Inclusion Criteria:

• patients treated with asciminib in Japan.

Exclusion Criteria:

NA

Related Conditions & MeSH terms

• Chronic Myeloid Leukemia
• Leukemia
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid

Intervention

Other:
• Asciminib
Prospective observational study. There is no treatment allocation. Patients prescribed with asciminib are eligible to enroll into this study.

Locations

Country	Name	City	State
Japan	Novartis Investigative Site	Aizuwakamatsu	Fukushima
Japan	Novartis Investigative Site	Akashi	Hyogo
Japan	Novartis Investigative Site	Akita
Japan	Novartis Investigative Site	Amagasaki	Hyogo
Japan	Novartis Investigative Site	Amagasaki city	Hyogo
Japan	Novartis Investigative Site	Anjo	Aichi
Japan	Novartis Investigative Site	Aomori
Japan	Novartis Investigative Site	Asahikawa-city	Hokkaido
Japan	Novartis Investigative Site	Asaka	Saitama
Japan	Novartis Investigative Site	Bunkyo ku	Tokyo
Japan	Novartis Investigative Site	Bunkyo ku	Tokyo
Japan	Novartis Investigative Site	Bunkyo-ku	Tokyo
Japan	Novartis Investigative Site	Chiba
Japan	Novartis Investigative Site	Chiba
Japan	Novartis Investigative Site	Chiba
Japan	Novartis Investigative Site	Chiyoda-ku	Tokyo
Japan	Novartis Investigative Site	Chiyoda-ku	Tokyo
Japan	Novartis Investigative Site	Chuo-city	Yamanashi
Japan	Novartis Investigative Site	Fujioka city	Gunma
Japan	Novartis Investigative Site	Fukaya	Saitama
Japan	Novartis Investigative Site	Fukuchiyama	Kyoto
Japan	Novartis Investigative Site	Fukui
Japan	Novartis Investigative Site	Fukui
Japan	Novartis Investigative Site	Fukuoka
Japan	Novartis Investigative Site	Fukuoka
Japan	Novartis Investigative Site	Fukuoka
Japan	Novartis Investigative Site	Fukuoka
Japan	Novartis Investigative Site	Fukuoka city	Fukuoka
Japan	Novartis Investigative Site	Fukushima
Japan	Novartis Investigative Site	Fukushima city	Fukushima
Japan	Novartis Investigative Site	Fukuyama	Hiroshima
Japan	Novartis Investigative Site	Funabashi	Chiba
Japan	Novartis Investigative Site	Gifu
Japan	Novartis Investigative Site	Gifu-city	Gifu
Japan	Novartis Investigative Site	Hachioji-city	Tokyo
Japan	Novartis Investigative Site	Hachioji-city	Tokyo
Japan	Novartis Investigative Site	Hakodate	Hokkaido
Japan	Novartis Investigative Site	Hamamatsu-city	Shizuoka
Japan	Novartis Investigative Site	Hamamatsu-city	Shizuoka
Japan	Novartis Investigative Site	Hidaka-city	Saitama
Japan	Novartis Investigative Site	Higashiibaraki-gun	Ibaraki
Japan	Novartis Investigative Site	Himeji	Hyogo
Japan	Novartis Investigative Site	Hirakata-city	Osaka
Japan	Novartis Investigative Site	Hiroshima
Japan	Novartis Investigative Site	Hiroshima
Japan	Novartis Investigative Site	Hiroshima
Japan	Novartis Investigative Site	Hiroshima
Japan	Novartis Investigative Site	Hitachi-city	Ibaraki
Japan	Novartis Investigative Site	Ichihara	Chiba
Japan	Novartis Investigative Site	Ichikawa	Chiba
Japan	Novartis Investigative Site	Ichinomiya	Aichi
Japan	Novartis Investigative Site	Ikoma	Nara
Japan	Novartis Investigative Site	Iruma-gun	Saitama
Japan	Novartis Investigative Site	Isahaya	Nagasaki
Japan	Novartis Investigative Site	Ishinomaki-city	Miyagi
Japan	Novartis Investigative Site	Ishioka	Ibaraki
Japan	Novartis Investigative Site	Itabashi ku	Tokyo
Japan	Novartis Investigative Site	Itabashi ku	Tokyo
Japan	Novartis Investigative Site	Itano	Tokushima
Japan	Novartis Investigative Site	Iwaki	Fukushima
Japan	Novartis Investigative Site	Iwamizawa-city	Hokkaido
Japan	Novartis Investigative Site	Iwata City	Shizuoka
Japan	Novartis Investigative Site	Izumisano-city	Osaka
Japan	Novartis Investigative Site	Izumo	Shimane
Japan	Novartis Investigative Site	Izumo-city	Shimane
Japan	Novartis Investigative Site	Izunokuni	Shizuoka
Japan	Novartis Investigative Site	Joetsu	Niigata
Japan	Novartis Investigative Site	Kakogawa-shi	Hyogo
Japan	Novartis Investigative Site	Kamakura-city	Kanagawa
Japan	Novartis Investigative Site	Kanazawa	Ishikawa
Japan	Novartis Investigative Site	Kanazawa-city	Ishikawa
Japan	Novartis Investigative Site	Kanoya	Kagoshima
Japan	Novartis Investigative Site	Karatsu	Saga
Japan	Novartis Investigative Site	Kashihara city	Nara
Japan	Novartis Investigative Site	Kashiwa	Chiba
Japan	Novartis Investigative Site	Kashiwa-city	Chiba
Japan	Novartis Investigative Site	Kasugai	Aichi
Japan	Novartis Investigative Site	Kawachinagano	Osaka
Japan	Novartis Investigative Site	Kawachinagano	Osaka
Japan	Novartis Investigative Site	Kawagoe	Saitama
Japan	Novartis Investigative Site	Kawasaki	Kanagawa
Japan	Novartis Investigative Site	Kawasaki-city	Kanagawa
Japan	Novartis Investigative Site	Kawasaki-city	Kanagawa
Japan	Novartis Investigative Site	Kinokawa	Wakayama
Japan	Novartis Investigative Site	Kirishima	Kagoshima
Japan	Novartis Investigative Site	Kisarazu	Chiba
Japan	Novartis Investigative Site	Kita-gun	Kagawa
Japan	Novartis Investigative Site	Kitakami	Iwate
Japan	Novartis Investigative Site	Kitakyushu-city	Fukuoka
Japan	Novartis Investigative Site	Kitakyushu-city	Fukuoka
Japan	Novartis Investigative Site	Kitakyushu-city	Fukuoka
Japan	Novartis Investigative Site	Kobe	Hyogo
Japan	Novartis Investigative Site	Kobe	Hyogo
Japan	Novartis Investigative Site	Kobe	Hyogo
Japan	Novartis Investigative Site	Kobe-city	Hyogo
Japan	Novartis Investigative Site	Kobe-city	Hyogo
Japan	Novartis Investigative Site	Kobe-shi	Hyogo
Japan	Novartis Investigative Site	Kochi city	Kochi
Japan	Novartis Investigative Site	Kofu-city	Yamanashi
Japan	Novartis Investigative Site	Koga	Ibaraki
Japan	Novartis Investigative Site	Komae	Tokyo
Japan	Novartis Investigative Site	Komaki	Aichi
Japan	Novartis Investigative Site	Komatsushima-city	Tokushima
Japan	Novartis Investigative Site	Konan	Aichi
Japan	Novartis Investigative Site	Koshigaya	Saitama
Japan	Novartis Investigative Site	Koto ku	Tokyo
Japan	Novartis Investigative Site	Kumamoto City	Kumamoto
Japan	Novartis Investigative Site	Kumamoto City	Kumamoto
Japan	Novartis Investigative Site	Kumamoto-city	Kumamoto
Japan	Novartis Investigative Site	Kumamoto-city	Kumamoto
Japan	Novartis Investigative Site	Kurashiki-city	Okayama
Japan	Novartis Investigative Site	Kurume-city	Fukuoka
Japan	Novartis Investigative Site	Kusatsu city	Shiga
Japan	Novartis Investigative Site	Kushiro	Hokkaido
Japan	Novartis Investigative Site	Kyoto
Japan	Novartis Investigative Site	Kyoto
Japan	Novartis Investigative Site	Kyoto
Japan	Novartis Investigative Site	Kyoto
Japan	Novartis Investigative Site	Kyoto
Japan	Novartis Investigative Site	Kyoto-city	Kyoto
Japan	Novartis Investigative Site	Maebashi	Gunma
Japan	Novartis Investigative Site	Maebashi city	Gunma
Japan	Novartis Investigative Site	Maebashi-city	Gunma
Japan	Novartis Investigative Site	Maizuru	Kyoto
Japan	Novartis Investigative Site	Masuda	Shimane
Japan	Novartis Investigative Site	Matsudo	Chiba
Japan	Novartis Investigative Site	Matsue	Shimane
Japan	Novartis Investigative Site	Matsuyama	Ehime
Japan	Novartis Investigative Site	Matsuyama-city	Ehime
Japan	Novartis Investigative Site	Matsuyama-city	Ehime
Japan	Novartis Investigative Site	Meguro	Tokyo
Japan	Novartis Investigative Site	Meguro-ku	Tokyo
Japan	Novartis Investigative Site	Mihara	Hiroshima
Japan	Novartis Investigative Site	Minamiuonuma	Niigata
Japan	Novartis Investigative Site	Minato ku	Tokyo
Japan	Novartis Investigative Site	Minato-ku	Tokyo
Japan	Novartis Investigative Site	Minato-ku	Tokyo
Japan	Novartis Investigative Site	Mitaka-city	Tokyo
Japan	Novartis Investigative Site	Miyakonojo	Miyazaki
Japan	Novartis Investigative Site	Miyakonojo	Miyazaki
Japan	Novartis Investigative Site	Miyazaki
Japan	Novartis Investigative Site	Miyazaki
Japan	Novartis Investigative Site	Moriguchi	Osaka
Japan	Novartis Investigative Site	Moriguchi	Osaka
Japan	Novartis Investigative Site	Morioka	Iwate
Japan	Novartis Investigative Site	Moriyama-City	Shiga
Japan	Novartis Investigative Site	Musashino-city	Tokyo
Japan	Novartis Investigative Site	Nagahama	Shiga
Japan	Novartis Investigative Site	Nagakute-city	Aichi
Japan	Novartis Investigative Site	Nagano-city	Nagano
Japan	Novartis Investigative Site	Nagaoka	Niigata
Japan	Novartis Investigative Site	Nagasaki
Japan	Novartis Investigative Site	Nagasaki-shi	Nagasaki
Japan	Novartis Investigative Site	Nago	Okinawa
Japan	Novartis Investigative Site	Nagoya	Aichi
Japan	Novartis Investigative Site	Nagoya	Aichi
Japan	Novartis Investigative Site	Nagoya	Aichi
Japan	Novartis Investigative Site	Nagoya-city	Aichi
Japan	Novartis Investigative Site	Nagoya-city	Aichi
Japan	Novartis Investigative Site	Naha	Okinawa
Japan	Novartis Investigative Site	Nanao	Ishikawa
Japan	Novartis Investigative Site	Nara
Japan	Novartis Investigative Site	Narita	Chiba
Japan	Novartis Investigative Site	Nerima-ku	Tokyo
Japan	Novartis Investigative Site	Niigata
Japan	Novartis Investigative Site	Nishinomiya	Hyogo
Japan	Novartis Investigative Site	Nishinomiya-city	Hyogo
Japan	Novartis Investigative Site	Nishinomiya-city	Hyogo
Japan	Novartis Investigative Site	Nobeoka	Miyazaki
Japan	Novartis Investigative Site	Nomi	Ishikawa
Japan	Novartis Investigative Site	Obihiro	Hokkaido
Japan	Novartis Investigative Site	Odate	Akita
Japan	Novartis Investigative Site	Oita
Japan	Novartis Investigative Site	Okayama
Japan	Novartis Investigative Site	Okayama city	Okayama
Japan	Novartis Investigative Site	Okayama-city	Okayama
Japan	Novartis Investigative Site	Okayama-city	Okayama
Japan	Novartis Investigative Site	Ome	Tokyo
Japan	Novartis Investigative Site	Omihachiman	Shiga
Japan	Novartis Investigative Site	Osaka
Japan	Novartis Investigative Site	Osaka
Japan	Novartis Investigative Site	Osaka
Japan	Novartis Investigative Site	Osaka
Japan	Novartis Investigative Site	Osaka
Japan	Novartis Investigative Site	Osaka
Japan	Novartis Investigative Site	Osaka
Japan	Novartis Investigative Site	Osaka Sayama	Osaka
Japan	Novartis Investigative Site	Osaka-city	Osaka
Japan	Novartis Investigative Site	Osaka-city	Osaka
Japan	Novartis Investigative Site	Osaka-city	Osaka
Japan	Novartis Investigative Site	Osaka-City	Osaka
Japan	Novartis Investigative Site	Ota-city	Gunma
Japan	Novartis Investigative Site	Saga-city	Saga
Japan	Novartis Investigative Site	Saitama
Japan	Novartis Investigative Site	Saitama
Japan	Novartis Investigative Site	Saitama
Japan	Novartis Investigative Site	Sakata-city	Yamagata
Japan	Novartis Investigative Site	Saku-city	Nagano
Japan	Novartis Investigative Site	Sano	Tochigi
Japan	Novartis Investigative Site	Sapporo	Hokkaido
Japan	Novartis Investigative Site	Sapporo	Hokkaido
Japan	Novartis Investigative Site	Sapporo	Hokkaido
Japan	Novartis Investigative Site	Sapporo	Hokkaido
Japan	Novartis Investigative Site	Sapporo-city	Hokkaido
Japan	Novartis Investigative Site	Sayama-city	Saitama
Japan	Novartis Investigative Site	Seki	Gifu
Japan	Novartis Investigative Site	Sendai	Miyagi
Japan	Novartis Investigative Site	Sendai city	Miyagi
Japan	Novartis Investigative Site	Sendai city	Miyagi
Japan	Novartis Investigative Site	Sendai-shi	Miyagi
Japan	Novartis Investigative Site	Seto-city	Aichi
Japan	Novartis Investigative Site	Shibata	Niigata
Japan	Novartis Investigative Site	Shibuya	Tokyo
Japan	Novartis Investigative Site	Shimada	Shizuoka
Japan	Novartis Investigative Site	Shimajiri-Gun	Okinawa
Japan	Novartis Investigative Site	Shimotsuke	Tochigi
Japan	Novartis Investigative Site	Shinagawa ku	Tokyo
Japan	Novartis Investigative Site	Shinagawa-ku	Tokyo
Japan	Novartis Investigative Site	Shinjuku ku	Tokyo
Japan	Novartis Investigative Site	Shinjuku ku	Tokyo
Japan	Novartis Investigative Site	Shinjuku-ku	Tokyo
Japan	Novartis Investigative Site	Shinjuku-ku	Tokyo
Japan	Novartis Investigative Site	Shiwa-gun	Iwate
Japan	Novartis Investigative Site	Shizuoka-city	Shizuoka
Japan	Novartis Investigative Site	Suginami	Tokyo
Japan	Novartis Investigative Site	Suita	Osaka
Japan	Novartis Investigative Site	Suita	Osaka
Japan	Novartis Investigative Site	Sumida-ku	Tokyo
Japan	Novartis Investigative Site	Sumoto	Hyogo
Japan	Novartis Investigative Site	Sunto Gun	Shizuoka
Japan	Novartis Investigative Site	Suwa	Nagano
Japan	Novartis Investigative Site	Tachikawa-city	Tokyo
Japan	Novartis Investigative Site	Takamatsu	Kagawa
Japan	Novartis Investigative Site	Takamatsu city	Kagawa
Japan	Novartis Investigative Site	Takamatsu-city	Kagawa
Japan	Novartis Investigative Site	Takatsuki	Osaka
Japan	Novartis Investigative Site	Takayama	Gifu
Japan	Novartis Investigative Site	Tenri	Nara
Japan	Novartis Investigative Site	Tochigi
Japan	Novartis Investigative Site	Tokai	Aichi
Japan	Novartis Investigative Site	Tokorozawa	Saitama
Japan	Novartis Investigative Site	Tokorozawa city	Saitama
Japan	Novartis Investigative Site	Tokushima
Japan	Novartis Investigative Site	Tonami	Toyama
Japan	Novartis Investigative Site	Tondabayashi	Osaka
Japan	Novartis Investigative Site	Toon city	Ehime
Japan	Novartis Investigative Site	Toyama
Japan	Novartis Investigative Site	Toyama
Japan	Novartis Investigative Site	Toyama-city	Toyama
Japan	Novartis Investigative Site	Toyama-City	Toyama
Japan	Novartis Investigative Site	Toyoake city	Aichi
Japan	Novartis Investigative Site	Toyohashi	Aichi
Japan	Novartis Investigative Site	Toyohashi	Aichi
Japan	Novartis Investigative Site	Toyonaka-city	Osaka
Japan	Novartis Investigative Site	Toyooka	Hyogo
Japan	Novartis Investigative Site	Tsu	Mie
Japan	Novartis Investigative Site	Tsu-city	Mie
Japan	Novartis Investigative Site	Tsuchiura	Ibaraki
Japan	Novartis Investigative Site	Tsukuba	Ibaraki
Japan	Novartis Investigative Site	Tsukuba city	Ibaraki
Japan	Novartis Investigative Site	Tsuyama	Okayama
Japan	Novartis Investigative Site	Ube	Yamaguchi
Japan	Novartis Investigative Site	Wakayama
Japan	Novartis Investigative Site	Wakayama
Japan	Novartis Investigative Site	Yamagata
Japan	Novartis Investigative Site	Yamagata
Japan	Novartis Investigative Site	Yamato	Kanagawa
Japan	Novartis Investigative Site	Yanagawa-city	Fukuoka
Japan	Novartis Investigative Site	Yatomi	Aichi
Japan	Novartis Investigative Site	Yokkaichi	Mie
Japan	Novartis Investigative Site	Yokohama	Kanagawa
Japan	Novartis Investigative Site	Yokohama	Kanagawa
Japan	Novartis Investigative Site	Yokohama city	Kanagawa
Japan	Novartis Investigative Site	Yokohama-city	Kanagawa
Japan	Novartis Investigative Site	Yokohama-city	Kanagawa
Japan	Novartis Investigative Site	Yonago-city	Tottori
Japan	Novartis Investigative Site	Yoshida-gun	Fukui
Japan	Novartis Investigative Site	Yufu	Oita

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Type, frequency, seriousness and severity of adverse event (AE)/treatment-related AE of the safety specifications	For the safety specifications (myelosuppression, infections, QT interval prolongation, pancreatitis, vascular occlusive events, photosensitivity), type, frequency AE, seriousness, severity of adverse event (AE)/treatment-related AE will be collected	Up to 48 Weeks
Primary	AEs leading to interruption/discontinuation of the safety specifications	For the safety specifications (myelosuppression, infections, QT interval prolongation, pancreatitis, vascular occlusive events, photosensitivity), AEs leading to interruption/discontinuation will be collected	Up to 48 Weeks
Primary	Number of patients with changes in relevant laboratory parameters for the safety specifications	For the safety specifications (myelosuppression, infections, QT interval prolongation, pancreatitis, vascular occlusive events, photosensitivity), number of patients with changes in relevant laboratory parameters will be collected	Up to 48 Weeks
Primary	Frequency of AEs/Treatment-related AEs by patient characteristic factor	Frequency of AEs/Treatment-related AEs by patient characteristic factor will be collected	Up to 48 Weeks
Secondary	Type, frequency, seriousness, severity of AEs/treatment-related AEs of the safety analysis set	Type, frequency, seriousness, severity of AEs/treatment-related AEs of the safety analysis set will be collected	Up to 48 Weeks
Secondary	AEs leading to interruption/discontinuation in the safety analysis set	AEs leading to interruption/discontinuation in the safety analysis set will be collected	Up to 48 Weeks
Secondary	Frequency of AEs/treatment-related AEs summarized by patient characteristic factor	Frequency of AEs/treatment-related AEs summarized by patient characteristic factor will be collected	Up to 48 Weeks
Secondary	Type, frequency, seriousness, severity of AEs/treatment-related AEs in patients with special characteristics	Type, frequency, seriousness, severity of AEs/treatment-related AEs in patients with special characteristics (patients with concurrent renal impairment/hepatic impairment/cardiac impairment, elderly, children, pregnant/parturient women) will be collected	Up to 48 Weeks
Secondary	AEs leading to interruption/discontinuation in patients with special characteristics	AEs leading to interruption/discontinuation in patients with special characteristics (patients with concurrent renal impairment/hepatic impairment/cardiac impairment, elderly, children, pregnant/parturient women) will be collected	Up to 48 Weeks
Secondary	Type, frequency, seriousness, severity and outcome of AEs/treatment-related AEs by treatment line	Type, frequency, seriousness, severity and outcome of AEs/treatment-related AEs by treatment line will be collected	Up to 48 Weeks
Secondary	Factors affecting occurrence of AEs by treatment line	Factors affecting occurrence of AEs by treatment line will be collected	Up to 48 Weeks
Secondary	AEs leading to interruption/discontinuation by treatment line	AEs leading to interruption/discontinuation by treatment line will be collected	Up to 48 Weeks
Secondary	Major molecular response (MMR) rates	Major molecular response is defined as BCR-ABL1 International Scale value = 0.1%.; BCR-ABL1: translocation-produced fusion gene	Week 12, Week 24, Week 48
Secondary	MMR rates by Week 48 by patient characteristics factor	Major molecular response (MMR) is defined as BCR-ABL1 International Scale value = 0.1%.; BCR-ABL1: translocation-produced fusion gene	Up to 48 Weeks
Secondary	MR4.0 and MR4.5 rates	MR4.0 and MR4.5 rates are defined as : MR4.0: BCR-ABL1 International Scale value = 0.01%; MR4.5: BCR-ABL1 International Scale value = 0.0032%; BCR-ABL1: translocation-produced fusion gene	Week 12, Week 24 and Week 48
Secondary	Complete cytogenetic response (CCyR) rates	This study will collect complete cytogenetic response (CCyR), which is defined as a state of Ph+ metaphase cell disappearance, i.e. Ph+ cell = 0%.	Week 12, Week 24 and Week 48
Secondary	Complete hematological response (CHR) rates	This study will collect complete hematological response (CHR), which is defined as meeting the following 6 criteria.; White blood cell count < 10,000/µL; Platelet count < 450,000/µL; No blast cell and promyelocyte in peripheral blood; Myelocyte + metamyelocyte in peripheral blood = 0%; Basophil < 5%; No spleen and liver swelling, and no extramedullary lesion	Week 12, Week 24 and Week 48
Secondary	Rate of patients with BCR-ABL1 gene mutations	This study will collect the rate of patients with BCR-ABL1 gene mutations	Up to 48 Weeks
Secondary	MMR rates by Week 48 in patients with special characteristics	This study will collect major molecular response (MMR) rates by Week 48 in patients with special characteristics (patients with concurrent renal impairment/hepatic impairment/cardiac impairment, elderly, children, pregnant/parturient women)	Week 48
Secondary	MMR rates by treatment line	This study will collect major molecular response (MMR) rates by treatment line	Week 12, Week 24 and Week 48
Secondary	MR4.0 and MR4.5 rates by treatment line	MR4.0 and MR4.5 rates are defined as : MR4.0: BCR-ABL1 International Scale value = 0.01%; MR4.5: BCR-ABL1 International Scale value = 0.0032%; BCR-ABL1: translocation-produced fusion gene	Week 12, Week 24 and Week 48
Secondary	CCyR rates by treatment line	This study will collect complete cytogenetic response (CCyR), which is defined as a state of Ph+ metaphase cell disappearance, i.e. Ph+ cell = 0%.	Week 12, Week 24 and Week 48
Secondary	CHR rates by treatment line	This study will collect complete hematological response (CHR), which is defined as meeting the following 6 criteria.; White blood cell count < 10,000/µL; Platelet count < 450,000/µL; No blast cell and promyelocyte in peripheral blood; Myelocyte + metamyelocyte in peripheral blood = 0%; Basophil < 5%; No spleen and liver swelling, and no extramedullary lesion	Week 12, Week 24 and Week 48