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Special Drug Use-results Surveillance of Scemblix Tablets

NCT ID: NCT05421091

Last Updated: 2024-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

550 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-07-04

Study Completion Date

2024-02-29

Brief Summary

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

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Detailed Description

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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.

Conditions

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Chronic Myeloid Leukemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Asciminib

Patients prescribed with Asciminib

Asciminib

Intervention Type OTHER

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

Interventions

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Asciminib

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* patients treated with asciminib in Japan.

Exclusion Criteria

NA
Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Anjo, Aichi-ken, Japan

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Ichinomiya, Aichi-ken, Japan

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Kasugai, Aichi-ken, Japan

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Komaki, Aichi-ken, Japan

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Kōnan, Aichi-ken, Japan

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Nagakute, Aichi-ken, Japan

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Nagoya, Aichi-ken, Japan

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Nagoya, Aichi-ken, Japan

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Nagoya, Aichi-ken, Japan

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Nagoya, Aichi-ken, Japan

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Nagoya, Aichi-ken, Japan

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Seto, Aichi-ken, Japan

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Toyoake, Aichi-ken, Japan

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Toyohashi, Aichi-ken, Japan

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Toyohashi, Aichi-ken, Japan

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Tōkai, Aichi-ken, Japan

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Yatomi, Aichi-ken, Japan

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Ōdate, Akita, Japan

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Funabashi, Chiba, Japan

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Ichihara, Chiba, Japan

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Ichikawa, Chiba, Japan

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Kashiwa, Chiba, Japan

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Kashiwa, Chiba, Japan

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Kisarazu, Chiba, Japan

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Matsudo, Chiba, Japan

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Narita, Chiba, Japan

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Matsuyama, Ehime, Japan

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Matsuyama, Ehime, Japan

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Matsuyama, Ehime, Japan

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Tōon, Ehime, Japan

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Yoshida-gun, Fukui, Japan

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Fukuoka, Fukuoka, Japan

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Kitakyushu, Fukuoka, Japan

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Kitakyushu, Fukuoka, Japan

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Kitakyushu, Fukuoka, Japan

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Kurume, Fukuoka, Japan

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Yanagawa, Fukuoka, Japan

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Aizu-Wakamatsu, Fukushima, Japan

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Fukushima, Fukushima, Japan

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Iwaki, Fukushima, Japan

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Gifu, Gifu, Japan

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Sekimachi, Gifu, Japan

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Takayama, Gifu, Japan

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Fujioka, Gunma, Japan

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Maebashi, Gunma, Japan

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Maebashi, Gunma, Japan

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Maebashi, Gunma, Japan

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Ōta, Gunma, Japan

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Fukuyama, Hiroshima, Japan

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Mihara, Hiroshima, Japan

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Asahikawa, Hokkaido, Japan

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Hakodate, Hokkaido, Japan

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Iwamizawa, Hokkaido, Japan

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Kushiro, Hokkaido, Japan

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Obihiro, Hokkaido, Japan

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Sapporo, Hokkaido, Japan

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Sapporo, Hokkaido, Japan

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Sapporo, Hokkaido, Japan

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Sapporo, Hokkaido, Japan

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Sapporo, Hokkaido, Japan

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Akashi, Hyōgo, Japan

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Amagasaki, Hyōgo, Japan

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Amagasaki, Hyōgo, Japan

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Himeji, Hyōgo, Japan

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Kakogawa-shi, Hyōgo, Japan

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Kobe, Hyōgo, Japan

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Kobe, Hyōgo, Japan

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Kobe, Hyōgo, Japan

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Nishinomiya, Hyōgo, Japan

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Nishinomiya, Hyōgo, Japan

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Nishinomiya, Hyōgo, Japan

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Sumoto, Hyōgo, Japan

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Toyooka, Hyōgo, Japan

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Higashiibaraki-gun, Ibaraki, Japan

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Hitachi, Ibaraki, Japan

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Ishioka, Ibaraki, Japan

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Koga, Ibaraki, Japan

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Tsuchiura, Ibaraki, Japan

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Tsukuba, Ibaraki, Japan

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Kanazawa, Ishikawa-ken, Japan

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Nanao, Ishikawa-ken, Japan

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Nomi, Ishikawa-ken, Japan

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Kitakami, Iwate, Japan

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Morioka, Iwate, Japan

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Shiwa-gun, Iwate, Japan

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Kita-gun, Kagawa-ken, Japan

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Kanoya, Kagoshima-ken, Japan

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Kirishima, Kagoshima-ken, Japan

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Kamakura, Kanagawa, Japan

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Yamato, Kanagawa, Japan

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Kochi, Kochi, Japan

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Sendai, Miyagi, Japan

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Miyakonojō, Miyazaki, Japan

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Nobeoka, Miyazaki, Japan

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Suwa, Nagano, Japan

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Isahaya, Nagasaki, Japan

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Nagasaki, Nagasaki, Japan

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Ikoma, Nara, Japan

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Kashihara, Nara, Japan

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Tenri, Nara, Japan

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Jōetsu, Niigata, Japan

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Minamiuonuma, Niigata, Japan

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Nagaoka, Niigata, Japan

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Shibata, Niigata, Japan

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Yufu, Oita Prefecture, Japan

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Kurashiki, Okayama-ken, Japan

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Okayama, Okayama-ken, Japan

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Okayama, Okayama-ken, Japan

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Okayama, Okayama-ken, Japan

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Tsuyama, Okayama-ken, Japan

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Nago, Okinawa, Japan

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Naha, Okinawa, Japan

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Shimajiri-Gun, Okinawa, Japan

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Hirakata, Osaka, Japan

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Izumisano, Osaka, Japan

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Kawachi-Nagano, Osaka, Japan

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Kawachi-Nagano, Osaka, Japan

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Moriguchi, Osaka, Japan

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Moriguchi, Osaka, Japan

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Osaka, Osaka, Japan

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Osaka, Osaka, Japan

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Osaka, Osaka, Japan

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Osaka, Osaka, Japan

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Ōsaka-sayama, Osaka, Japan

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Suita, Osaka, Japan

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Suita, Osaka, Japan

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Takatsuki, Osaka, Japan

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Tondabayashi, Osaka, Japan

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Toyonaka, Osaka, Japan

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Karatsu, Saga-ken, Japan

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Saga, Saga-ken, Japan

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Asaka, Saitama, Japan

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Fukaya, Saitama, Japan

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Hidaka, Saitama, Japan

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Iruma-gun, Saitama, Japan

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Kawagoe, Saitama, Japan

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Koshigaya, Saitama, Japan

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Sayama, Saitama, Japan

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Tokorozawa, Saitama, Japan

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Tokorozawa, Saitama, Japan

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Kusatsu, Shiga, Japan

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Moriyama, Shiga, Japan

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Nagahama, Shiga, Japan

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Ōmihachiman, Shiga, Japan

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Izumo, Shimane, Japan

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Izumo, Shimane, Japan

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Masuda, Shimane, Japan

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Matsue, Shimane, Japan

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Hamamatsu, Shizuoka, Japan

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Hamamatsu, Shizuoka, Japan

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Iwata, Shizuoka, Japan

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Izunokuni, Shizuoka, Japan

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Shimada, Shizuoka, Japan

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Shizuoka, Shizuoka, Japan

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Sunto Gun, Shizuoka, Japan

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Sano, Tochigi, Japan

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Shimotsuke, Tochigi, Japan

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Komatsushimachō, Tokushima, Japan

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Okuno, Tokushima, Japan

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Bunkyo Ku, Tokyo, Japan

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Bunkyo Ku, Tokyo, Japan

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Bunkyo-ku, Tokyo, Japan

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Chiyoda-ku, Tokyo, Japan

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Chiyoda-ku, Tokyo, Japan

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Hachiōji, Tokyo, Japan

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Hachiōji, Tokyo, Japan

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Itabashi Ku, Tokyo, Japan

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Itabashi Ku, Tokyo, Japan

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Komae, Tokyo, Japan

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Koto Ku, Tokyo, Japan

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Meguro City, Tokyo, Japan

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Meguro-ku, Tokyo, Japan

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Minato Ku, Tokyo, Japan

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Minato-ku, Tokyo, Japan

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Minato-ku, Tokyo, Japan

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Mitaka, Tokyo, Japan

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Musashino, Tokyo, Japan

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Nerima-ku, Tokyo, Japan

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Ōme, Tokyo, Japan

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Shibuya City, Tokyo, Japan

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Shinagawa Ku, Tokyo, Japan

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Shinagawa-ku, Tokyo, Japan

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Shinjuku Ku, Tokyo, Japan

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Shinjuku Ku, Tokyo, Japan

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Shinjuku-ku, Tokyo, Japan

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Shinjuku-ku, Tokyo, Japan

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Suginami, Tokyo, Japan

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Sumida-ku, Tokyo, Japan

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Tachikawa, Tokyo, Japan

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Yonago, Tottori, Japan

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Tonami, Toyama, Japan

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Toyama, Toyama, Japan

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Toyama, Toyama, Japan

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Kinokawa, Wakayama, Japan

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Sakata, Yamagata, Japan

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Ube, Yamaguchi, Japan

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Chūō, Yamanashi, Japan

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Kofu, Yamanashi, Japan

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Akita, , Japan

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Aomori, , Japan

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Chiba, , Japan

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Chiba, , Japan

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Chiba, , Japan

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Fukui, , Japan

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Fukui, , Japan

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Fukuoka, , Japan

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Fukuoka, , Japan

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Fukuoka, , Japan

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Fukuoka, , Japan

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Fukushima, , Japan

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Gifu, , Japan

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Hiroshima, , Japan

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Hiroshima, , Japan

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Hiroshima, , Japan

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Hiroshima, , Japan

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Kyoto, , Japan

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Kyoto, , Japan

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Kyoto, , Japan

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Kyoto, , Japan

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Kyoto, , Japan

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Miyazaki, , Japan

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Miyazaki, , Japan

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Nagasaki, , Japan

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Nara, , Japan

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Niigata, , Japan

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Okayama, , Japan

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Osaka, , Japan

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Osaka, , Japan

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Osaka, , Japan

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Osaka, , Japan

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Osaka, , Japan

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Osaka, , Japan

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Osaka, , Japan

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Ōita, , Japan

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Saitama, , Japan

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Saitama, , Japan

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Saitama, , Japan

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Tochigi, , Japan

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Tokushima, , Japan

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Toyama, , Japan

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Toyama, , Japan

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Wakayama, , Japan

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Wakayama, , Japan

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Yamagata, , Japan

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Novartis Investigative Site

Yamagata, , Japan

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Countries

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Japan

Other Identifiers

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CABL001A1401

Identifier Type: -

Identifier Source: org_study_id

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A Study of Revumenib in Combination With Chemotherapy in Participants With R/R Acute Leukemia
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Study to Assess the Safety, Tolerability, and Efficacy of Tipifarnib Plus Bortezomib in the Treatment of Acute Myeloid Leukemia
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Asciminib in Monotherapy for Chronic Myeloid Leukemia in Chronic Phase (CML-CP) With and Without T315I Mutation
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A Study of JNJ-90189892 for Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Neoplasms
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Treatment With Acalabrutinib Post Blood or Marrow Transplantation in Subjects With Mantle Cell Lymphoma
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Safety Study of LBH589 When Given in Combination With Bortezomib in Adult Patients With Multiple Myeloma
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A Study to Customize Ibrutinib Treatment Regimens for Participants With Previously Untreated Chronic Lymphocytic Leukemia
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A Study of Bleximenib in Combination With Acute Myeloid Leukemia (AML) Directed Therapies
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Asciminib as Initial Therapy for Patients With Chronic Myeloid Leukemia in Chronic Phase
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