Special Drug Use-results Surveillance of Scemblix Tablets

March 26, 2024 updated by: Novartis Pharmaceuticals

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

550

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Akita, Japan, 010-8543
        • Novartis Investigative Site
      • Aomori, Japan, 030 8553
        • Novartis Investigative Site
      • Chiba, Japan, 260-8717
        • Novartis Investigative Site
      • Chiba, Japan, 260-0852
        • Novartis Investigative Site
      • Chiba, Japan, 2608677
        • Novartis Investigative Site
      • Fukui, Japan, 918-8503
        • Novartis Investigative Site
      • Fukui, Japan, 910-0026
        • Novartis Investigative Site
      • Fukuoka, Japan, 812-0033
        • Novartis Investigative Site
      • Fukuoka, Japan, 819-8585
        • Novartis Investigative Site
      • Fukuoka, Japan, 813-8501
        • Novartis Investigative Site
      • Fukuoka, Japan, 815-8555
        • Novartis Investigative Site
      • Fukushima, Japan, 960-1101
        • Novartis Investigative Site
      • Gifu, Japan, 500-8717
        • Novartis Investigative Site
      • Hiroshima, Japan, 734-8551
        • Novartis Investigative Site
      • Hiroshima, Japan, 730-8619
        • Novartis Investigative Site
      • Hiroshima, Japan, 731-0232
        • Novartis Investigative Site
      • Hiroshima, Japan, 731-5156
        • Novartis Investigative Site
      • Kyoto, Japan, 606 8507
        • Novartis Investigative Site
      • Kyoto, Japan, 605-0981
        • Novartis Investigative Site
      • Kyoto, Japan, 603-8151
        • Novartis Investigative Site
      • Kyoto, Japan, 606-8273
        • Novartis Investigative Site
      • Kyoto, Japan, 615-8256
        • Novartis Investigative Site
      • Miyazaki, Japan, 880-0041
        • Novartis Investigative Site
      • Miyazaki, Japan, 880-8510
        • Novartis Investigative Site
      • Nagasaki, Japan, 850-8555
        • Novartis Investigative Site
      • Nara, Japan, 630-8305
        • Novartis Investigative Site
      • Niigata, Japan, 951 8520
        • Novartis Investigative Site
      • Oita, Japan, 870-1133
        • Novartis Investigative Site
      • Okayama, Japan, 700-8557
        • Novartis Investigative Site
      • Osaka, Japan, 545-8586
        • Novartis Investigative Site
      • Osaka, Japan, 534-0021
        • Novartis Investigative Site
      • Osaka, Japan, 536-0001
        • Novartis Investigative Site
      • Osaka, Japan, 540-0008
        • Novartis Investigative Site
      • Osaka, Japan, 542-0081
        • Novartis Investigative Site
      • Osaka, Japan, 543-8922
        • Novartis Investigative Site
      • Osaka, Japan, 553-0003
        • Novartis Investigative Site
      • Saitama, Japan, 330 8777
        • Novartis Investigative Site
      • Saitama, Japan, 330-0074
        • Novartis Investigative Site
      • Saitama, Japan, 336-0911
        • Novartis Investigative Site
      • Tochigi, Japan, 329-4407
        • Novartis Investigative Site
      • Tokushima, Japan, 770-0812
        • Novartis Investigative Site
      • Toyama, Japan, 930-8550
        • Novartis Investigative Site
      • Toyama, Japan, 930-0859
        • Novartis Investigative Site
      • Wakayama, Japan, 641-8510
        • Novartis Investigative Site
      • Wakayama, Japan, 640-8558
        • Novartis Investigative Site
      • Yamagata, Japan, 990-2214
        • Novartis Investigative Site
      • Yamagata, Japan, 992-8502
        • Novartis Investigative Site
    • Aichi
      • Anjo, Aichi, Japan, 446-8602
        • Novartis Investigative Site
      • Ichinomiya, Aichi, Japan, 491-0041
        • Novartis Investigative Site
      • Kasugai, Aichi, Japan, 486-8510
        • Novartis Investigative Site
      • Komaki, Aichi, Japan, 485-8520
        • Novartis Investigative Site
      • Konan, Aichi, Japan, 483-8704
        • Novartis Investigative Site
      • Nagakute-city, Aichi, Japan, 480-1195
        • Novartis Investigative Site
      • Nagoya, Aichi, Japan, 453-8511
        • Novartis Investigative Site
      • Nagoya, Aichi, Japan, 460-0001
        • Novartis Investigative Site
      • Nagoya, Aichi, Japan, 457 8510
        • Novartis Investigative Site
      • Nagoya-city, Aichi, Japan, 467-8602
        • Novartis Investigative Site
      • Nagoya-city, Aichi, Japan, 466-8650
        • Novartis Investigative Site
      • Seto-city, Aichi, Japan, 489-8642
        • Novartis Investigative Site
      • Tokai, Aichi, Japan, 477-8522
        • Novartis Investigative Site
      • Toyoake city, Aichi, Japan, 470 1192
        • Novartis Investigative Site
      • Toyohashi, Aichi, Japan, 441-8570
        • Novartis Investigative Site
      • Toyohashi, Aichi, Japan, 441-8111
        • Novartis Investigative Site
      • Yatomi, Aichi, Japan, 498-8502
        • Novartis Investigative Site
    • Akita
      • Odate, Akita, Japan, 017-8550
        • Novartis Investigative Site
    • Chiba
      • Funabashi, Chiba, Japan, 273-8556
        • Novartis Investigative Site
      • Ichihara, Chiba, Japan, 290-0003
        • Novartis Investigative Site
      • Ichikawa, Chiba, Japan, 272-8513
        • Novartis Investigative Site
      • Kashiwa, Chiba, Japan, 277 8577
        • Novartis Investigative Site
      • Kashiwa-city, Chiba, Japan, 277-8567
        • Novartis Investigative Site
      • Kisarazu, Chiba, Japan, 292-8535
        • Novartis Investigative Site
      • Matsudo, Chiba, Japan, 270-0034
        • Novartis Investigative Site
      • Narita, Chiba, Japan, 286-8523
        • Novartis Investigative Site
    • Ehime
      • Matsuyama, Ehime, Japan, 790-0067
        • Novartis Investigative Site
      • Matsuyama-city, Ehime, Japan, 790-8524
        • Novartis Investigative Site
      • Matsuyama-city, Ehime, Japan, 790-0024
        • Novartis Investigative Site
      • Toon city, Ehime, Japan, 791-0295
        • Novartis Investigative Site
    • Fukui
      • Yoshida-gun, Fukui, Japan, 910-1193
        • Novartis Investigative Site
    • Fukuoka
      • Fukuoka city, Fukuoka, Japan, 812-8582
        • Novartis Investigative Site
      • Kitakyushu-city, Fukuoka, Japan, 802-8555
        • Novartis Investigative Site
      • Kitakyushu-city, Fukuoka, Japan, 806-8501
        • Novartis Investigative Site
      • Kitakyushu-city, Fukuoka, Japan, 807-8556
        • Novartis Investigative Site
      • Kurume-city, Fukuoka, Japan, 830-8543
        • Novartis Investigative Site
      • Yanagawa-city, Fukuoka, Japan, 832-0059
        • Novartis Investigative Site
    • Fukushima
      • Aizuwakamatsu, Fukushima, Japan, 969-3482
        • Novartis Investigative Site
      • Fukushima city, Fukushima, Japan, 960 1295
        • Novartis Investigative Site
      • Iwaki, Fukushima, Japan, 973-8402
        • Novartis Investigative Site
    • Gifu
      • Gifu-city, Gifu, Japan, 501-1194
        • Novartis Investigative Site
      • Seki, Gifu, Japan, 501-3802
        • Novartis Investigative Site
      • Takayama, Gifu, Japan, 506-8550
        • Novartis Investigative Site
    • Gunma
      • Fujioka city, Gunma, Japan, 375-8503
        • Novartis Investigative Site
      • Maebashi, Gunma, Japan, 371-0821
        • Novartis Investigative Site
      • Maebashi city, Gunma, Japan, 371 8511
        • Novartis Investigative Site
      • Maebashi-city, Gunma, Japan, 371-0811
        • Novartis Investigative Site
      • Ota-city, Gunma, Japan, 373-8550
        • Novartis Investigative Site
    • Hiroshima
      • Fukuyama, Hiroshima, Japan, 720-0001
        • Novartis Investigative Site
      • Mihara, Hiroshima, Japan, 723-0014
        • Novartis Investigative Site
    • Hokkaido
      • Asahikawa-city, Hokkaido, Japan, 078-8211
        • Novartis Investigative Site
      • Hakodate, Hokkaido, Japan, 041-0821
        • Novartis Investigative Site
      • Iwamizawa-city, Hokkaido, Japan, 068-8555
        • Novartis Investigative Site
      • Kushiro, Hokkaido, Japan, 085-0052
        • Novartis Investigative Site
      • Obihiro, Hokkaido, Japan, 080-0024
        • Novartis Investigative Site
      • Sapporo, Hokkaido, Japan, 060-8543
        • Novartis Investigative Site
      • Sapporo, Hokkaido, Japan, 003-0006
        • Novartis Investigative Site
      • Sapporo, Hokkaido, Japan, 007-0805
        • Novartis Investigative Site
      • Sapporo, Hokkaido, Japan, 060-0004
        • Novartis Investigative Site
      • Sapporo-city, Hokkaido, Japan, 004-8618
        • Novartis Investigative Site
    • Hyogo
      • Akashi, Hyogo, Japan, 673-8558
        • Novartis Investigative Site
      • Amagasaki, Hyogo, Japan, 660-8511
        • Novartis Investigative Site
      • Amagasaki city, Hyogo, Japan, 660 8550
        • Novartis Investigative Site
      • Himeji, Hyogo, Japan, 670-8540
        • Novartis Investigative Site
      • Kakogawa-shi, Hyogo, Japan, 675-8611
        • Novartis Investigative Site
      • Kobe, Hyogo, Japan, 651-0072
        • Novartis Investigative Site
      • Kobe, Hyogo, Japan, 651-2273
        • Novartis Investigative Site
      • Kobe, Hyogo, Japan, 657-0064
        • Novartis Investigative Site
      • Kobe-city, Hyogo, Japan, 650-0047
        • Novartis Investigative Site
      • Kobe-city, Hyogo, Japan, 651-1145
        • Novartis Investigative Site
      • Kobe-shi, Hyogo, Japan, 650-0017
        • Novartis Investigative Site
      • Nishinomiya, Hyogo, Japan, 663 8501
        • Novartis Investigative Site
      • Nishinomiya-city, Hyogo, Japan, 663-8186
        • Novartis Investigative Site
      • Nishinomiya-city, Hyogo, Japan, 662-0918
        • Novartis Investigative Site
      • Sumoto, Hyogo, Japan, 656-0021
        • Novartis Investigative Site
      • Toyooka, Hyogo, Japan, 668-8501
        • Novartis Investigative Site
    • Ibaraki
      • Higashiibaraki-gun, Ibaraki, Japan, 311-3193
        • Novartis Investigative Site
      • Hitachi-city, Ibaraki, Japan, 317-0077
        • Novartis Investigative Site
      • Ishioka, Ibaraki, Japan, 315-0037
        • Novartis Investigative Site
      • Koga, Ibaraki, Japan, 306-0232
        • Novartis Investigative Site
      • Tsuchiura, Ibaraki, Japan, 300-0028
        • Novartis Investigative Site
      • Tsukuba, Ibaraki, Japan, 300-2622
        • Novartis Investigative Site
      • Tsukuba city, Ibaraki, Japan, 305-8576
        • Novartis Investigative Site
    • Ishikawa
      • Kanazawa, Ishikawa, Japan, 920-0853
        • Novartis Investigative Site
      • Kanazawa-city, Ishikawa, Japan, 920-8641
        • Novartis Investigative Site
      • Nanao, Ishikawa, Japan, 926-0866
        • Novartis Investigative Site
      • Nomi, Ishikawa, Japan, 923-1226
        • Novartis Investigative Site
    • Iwate
      • Kitakami, Iwate, Japan, 024-0004
        • Novartis Investigative Site
      • Morioka, Iwate, Japan, 020 0066
        • Novartis Investigative Site
      • Shiwa-gun, Iwate, Japan, 028-3695
        • Novartis Investigative Site
    • Kagawa
      • Kita-gun, Kagawa, Japan, 761-0793
        • Novartis Investigative Site
      • Takamatsu, Kagawa, Japan, 761-8538
        • Novartis Investigative Site
      • Takamatsu city, Kagawa, Japan, 760 8557
        • Novartis Investigative Site
      • Takamatsu-city, Kagawa, Japan, 760-0017
        • Novartis Investigative Site
    • Kagoshima
      • Kanoya, Kagoshima, Japan, 893-0024
        • Novartis Investigative Site
      • Kirishima, Kagoshima, Japan, 899-5112
        • Novartis Investigative Site
    • Kanagawa
      • Kamakura-city, Kanagawa, Japan, 247-8533
        • Novartis Investigative Site
      • Kawasaki, Kanagawa, Japan, 211-8510
        • Novartis Investigative Site
      • Kawasaki-city, Kanagawa, Japan, 216-8511
        • Novartis Investigative Site
      • Kawasaki-city, Kanagawa, Japan, 255
        • Novartis Investigative Site
      • Yamato, Kanagawa, Japan, 242-8602
        • Novartis Investigative Site
      • Yokohama, Kanagawa, Japan, 241-0811
        • Novartis Investigative Site
      • Yokohama, Kanagawa, Japan, 221-0855
        • Novartis Investigative Site
      • Yokohama city, Kanagawa, Japan, 232 0024
        • Novartis Investigative Site
      • Yokohama-city, Kanagawa, Japan, 236-0004
        • Novartis Investigative Site
      • Yokohama-city, Kanagawa, Japan, 227-8501
        • Novartis Investigative Site
    • Kochi
      • Kochi city, Kochi, Japan, 781 8555
        • Novartis Investigative Site
    • Kumamoto
      • Kumamoto City, Kumamoto, Japan, 860-8556
        • Novartis Investigative Site
      • Kumamoto City, Kumamoto, Japan, 862-8655
        • Novartis Investigative Site
      • Kumamoto-city, Kumamoto, Japan, 861-4193
        • Novartis Investigative Site
      • Kumamoto-city, Kumamoto, Japan, 861-8520
        • Novartis Investigative Site
    • Kyoto
      • Fukuchiyama, Kyoto, Japan, 620-8505
        • Novartis Investigative Site
      • Kyoto-city, Kyoto, Japan, 604-8845
        • Novartis Investigative Site
      • Maizuru, Kyoto, Japan, 625-0036
        • Novartis Investigative Site
    • Mie
      • Tsu, Mie, Japan, 514-0057
        • Novartis Investigative Site
      • Tsu-city, Mie, Japan, 514-8507
        • Novartis Investigative Site
      • Yokkaichi, Mie, Japan, 510-8567
        • Novartis Investigative Site
    • Miyagi
      • Ishinomaki-city, Miyagi, Japan, 986-0861
        • Novartis Investigative Site
      • Sendai, Miyagi, Japan, 982-0007
        • Novartis Investigative Site
      • Sendai city, Miyagi, Japan, 980 8574
        • Novartis Investigative Site
      • Sendai city, Miyagi, Japan, 983 8512
        • Novartis Investigative Site
      • Sendai-shi, Miyagi, Japan, 983 8520
        • Novartis Investigative Site
    • Miyazaki
      • Miyakonojo, Miyazaki, Japan, 885-0014
        • Novartis Investigative Site
      • Miyakonojo, Miyazaki, Japan, 885-0035
        • Novartis Investigative Site
      • Nobeoka, Miyazaki, Japan, 882-0835
        • Novartis Investigative Site
    • Nagano
      • Nagano-city, Nagano, Japan, 380-8582
        • Novartis Investigative Site
      • Saku-city, Nagano, Japan, 3850051
        • Novartis Investigative Site
      • Suwa, Nagano, Japan, 392-8510
        • Novartis Investigative Site
    • Nagasaki
      • Isahaya, Nagasaki, Japan, 854-0071
        • Novartis Investigative Site
      • Nagasaki-shi, Nagasaki, Japan, 852-8511
        • Novartis Investigative Site
    • Nara
      • Ikoma, Nara, Japan, 630-0293
        • Novartis Investigative Site
      • Kashihara city, Nara, Japan, 634 8522
        • Novartis Investigative Site
      • Tenri, Nara, Japan, 632-8552
        • Novartis Investigative Site
    • Niigata
      • Joetsu, Niigata, Japan, 943-0147
        • Novartis Investigative Site
      • Minamiuonuma, Niigata, Japan, 949-7302
        • Novartis Investigative Site
      • Nagaoka, Niigata, Japan, 940-2085
        • Novartis Investigative Site
      • Shibata, Niigata, Japan, 957-8588
        • Novartis Investigative Site
    • Oita
      • Yufu, Oita, Japan, 879-5593
        • Novartis Investigative Site
    • Okayama
      • Kurashiki-city, Okayama, Japan, 710-8602
        • Novartis Investigative Site
      • Okayama city, Okayama, Japan, 701-1192
        • Novartis Investigative Site
      • Okayama-city, Okayama, Japan, 700-8558
        • Novartis Investigative Site
      • Okayama-city, Okayama, Japan, 700-8607
        • Novartis Investigative Site
      • Tsuyama, Okayama, Japan, 708-0841
        • Novartis Investigative Site
    • Okinawa
      • Nago, Okinawa, Japan, 905-0011
        • Novartis Investigative Site
      • Naha, Okinawa, Japan, 902-8511
        • Novartis Investigative Site
      • Shimajiri-Gun, Okinawa, Japan, 901-1303
        • Novartis Investigative Site
    • Osaka
      • Hirakata-city, Osaka, Japan, 573-1191
        • Novartis Investigative Site
      • Izumisano-city, Osaka, Japan, 598-8577
        • Novartis Investigative Site
      • Kawachinagano, Osaka, Japan, 586-8521
        • Novartis Investigative Site
      • Kawachinagano, Osaka, Japan, 586-0008
        • Novartis Investigative Site
      • Moriguchi, Osaka, Japan, 570-8507
        • Novartis Investigative Site
      • Moriguchi, Osaka, Japan, 570-8540
        • Novartis Investigative Site
      • Osaka Sayama, Osaka, Japan, 589 8511
        • Novartis Investigative Site
      • Osaka-City, Osaka, Japan, 550-0006
        • Novartis Investigative Site
      • Osaka-city, Osaka, Japan, 543-8555
        • Novartis Investigative Site
      • Osaka-city, Osaka, Japan, 541-8567
        • Novartis Investigative Site
      • Osaka-city, Osaka, Japan, 530-0012
        • Novartis Investigative Site
      • Suita, Osaka, Japan, 565 0871
        • Novartis Investigative Site
      • Suita, Osaka, Japan, 564-0082
        • Novartis Investigative Site
      • Takatsuki, Osaka, Japan, 569-1096
        • Novartis Investigative Site
      • Tondabayashi, Osaka, Japan, 584-0091
        • Novartis Investigative Site
      • Toyonaka-city, Osaka, Japan, 560-8565
        • Novartis Investigative Site
    • Saga
      • Karatsu, Saga, Japan, 847-0000
        • Novartis Investigative Site
      • Saga-city, Saga, Japan, 849-8501
        • Novartis Investigative Site
    • Saitama
      • Asaka, Saitama, Japan, 351-0021
        • Novartis Investigative Site
      • Fukaya, Saitama, Japan, 366-0052
        • Novartis Investigative Site
      • Hidaka-city, Saitama, Japan, 350-1298
        • Novartis Investigative Site
      • Iruma-gun, Saitama, Japan, 350-0495
        • Novartis Investigative Site
      • Kawagoe, Saitama, Japan, 350 8550
        • Novartis Investigative Site
      • Koshigaya, Saitama, Japan, 343-8555
        • Novartis Investigative Site
      • Sayama-city, Saitama, Japan, 350-1305
        • Novartis Investigative Site
      • Tokorozawa, Saitama, Japan, 359-0037
        • Novartis Investigative Site
      • Tokorozawa city, Saitama, Japan, 359 8513
        • Novartis Investigative Site
    • Shiga
      • Kusatsu city, Shiga, Japan, 525 8585
        • Novartis Investigative Site
      • Moriyama-City, Shiga, Japan, 524-8524
        • Novartis Investigative Site
      • Nagahama, Shiga, Japan, 526-0831
        • Novartis Investigative Site
      • Omihachiman, Shiga, Japan, 523-0082
        • Novartis Investigative Site
    • Shimane
      • Izumo, Shimane, Japan, 693-0068
        • Novartis Investigative Site
      • Izumo-city, Shimane, Japan, 693 8501
        • Novartis Investigative Site
      • Masuda, Shimane, Japan, 698-0003
        • Novartis Investigative Site
      • Matsue, Shimane, Japan, 690-8506
        • Novartis Investigative Site
    • Shizuoka
      • Hamamatsu-city, Shizuoka, Japan, 430-8558
        • Novartis Investigative Site
      • Hamamatsu-city, Shizuoka, Japan, 431-3192
        • Novartis Investigative Site
      • Iwata City, Shizuoka, Japan, 438-8550
        • Novartis Investigative Site
      • Izunokuni, Shizuoka, Japan, 410-2295
        • Novartis Investigative Site
      • Shimada, Shizuoka, Japan, 427-8502
        • Novartis Investigative Site
      • Shizuoka-city, Shizuoka, Japan, 420-8630
        • Novartis Investigative Site
      • Sunto Gun, Shizuoka, Japan, 411 8777
        • Novartis Investigative Site
    • Tochigi
      • Sano, Tochigi, Japan, 327-8511
        • Novartis Investigative Site
      • Shimotsuke, Tochigi, Japan, 329-0498
        • Novartis Investigative Site
    • Tokushima
      • Itano, Tokushima, Japan, 771-0204
        • Novartis Investigative Site
      • Komatsushima-city, Tokushima, Japan, 773-8502
        • Novartis Investigative Site
    • Tokyo
      • Bunkyo ku, Tokyo, Japan, 113-8677
        • Novartis Investigative Site
      • Bunkyo ku, Tokyo, Japan, 113-8431
        • Novartis Investigative Site
      • Bunkyo-ku, Tokyo, Japan, 113-8603
        • Novartis Investigative Site
      • Chiyoda-ku, Tokyo, Japan, 102-8798
        • Novartis Investigative Site
      • Chiyoda-ku, Tokyo, Japan, 101-8643
        • Novartis Investigative Site
      • Hachioji-city, Tokyo, Japan, 193-0944
        • Novartis Investigative Site
      • Hachioji-city, Tokyo, Japan, 192-0032
        • Novartis Investigative Site
      • Itabashi ku, Tokyo, Japan, 173 0015
        • Novartis Investigative Site
      • Itabashi ku, Tokyo, Japan, 173 8606
        • Novartis Investigative Site
      • Komae, Tokyo, Japan, 201-8601
        • Novartis Investigative Site
      • Koto ku, Tokyo, Japan, 135 8550
        • Novartis Investigative Site
      • Meguro, Tokyo, Japan, 153-8581
        • Novartis Investigative Site
      • Meguro-ku, Tokyo, Japan, 152-8902
        • Novartis Investigative Site
      • Minato ku, Tokyo, Japan, 105-8470
        • Novartis Investigative Site
      • Minato-ku, Tokyo, Japan, 108-8639
        • Novartis Investigative Site
      • Minato-ku, Tokyo, Japan, 105-8471
        • Novartis Investigative Site
      • Mitaka-city, Tokyo, Japan, 181-8611
        • Novartis Investigative Site
      • Musashino-city, Tokyo, Japan, 180-8610
        • Novartis Investigative Site
      • Nerima-ku, Tokyo, Japan, 113-0033
        • Novartis Investigative Site
      • Ome, Tokyo, Japan, 198-0042
        • Novartis Investigative Site
      • Shibuya, Tokyo, Japan, 150-8935
        • Novartis Investigative Site
      • Shinagawa ku, Tokyo, Japan, 141 8625
        • Novartis Investigative Site
      • Shinagawa-ku, Tokyo, Japan, 142-8666
        • Novartis Investigative Site
      • Shinjuku ku, Tokyo, Japan, 162 8655
        • Novartis Investigative Site
      • Shinjuku ku, Tokyo, Japan, 162 8666
        • Novartis Investigative Site
      • Shinjuku-ku, Tokyo, Japan, 160-0023
        • Novartis Investigative Site
      • Shinjuku-ku, Tokyo, Japan, 160 8582
        • Novartis Investigative Site
      • Suginami, Tokyo, Japan, 166-0001
        • Novartis Investigative Site
      • Sumida-ku, Tokyo, Japan, 130-8575
        • Novartis Investigative Site
      • Tachikawa-city, Tokyo, Japan, 190-8531
        • Novartis Investigative Site
    • Tottori
      • Yonago-city, Tottori, Japan, 683-8504
        • Novartis Investigative Site
    • Toyama
      • Tonami, Toyama, Japan, 939-1343
        • Novartis Investigative Site
      • Toyama-City, Toyama, Japan, 939-8511
        • Novartis Investigative Site
      • Toyama-city, Toyama, Japan, 930-0194
        • Novartis Investigative Site
    • Wakayama
      • Kinokawa, Wakayama, Japan, 649-6414
        • Novartis Investigative Site
    • Yamagata
      • Sakata-city, Yamagata, Japan, 998-8501
        • Novartis Investigative Site
    • Yamaguchi
      • Ube, Yamaguchi, Japan, 755-8505
        • Novartis Investigative Site
    • Yamanashi
      • Chuo-city, Yamanashi, Japan, 409-3898
        • Novartis Investigative Site
      • Kofu-city, Yamanashi, Japan, 400-8506
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 99 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients treated with asciminib

Description

Inclusion Criteria:

  • patients treated with asciminib in Japan.

Exclusion Criteria:

NA

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Asciminib
Patients prescribed with Asciminib
Other: Asciminib
Prospective observational study. There is no treatment allocation. Patients prescribed with asciminib are eligible to enroll into this study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Type, frequency, seriousness and severity of adverse event (AE)/treatment-related AE of the safety specifications
Time Frame: Up to 48 Weeks
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
AEs leading to interruption/discontinuation of the safety specifications
Time Frame: Up to 48 Weeks
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
Number of patients with changes in relevant laboratory parameters for the safety specifications
Time Frame: Up to 48 Weeks
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
Frequency of AEs/Treatment-related AEs by patient characteristic factor
Time Frame: Up to 48 Weeks
Frequency of AEs/Treatment-related AEs by patient characteristic factor will be collected
Up to 48 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Type, frequency, seriousness, severity of AEs/treatment-related AEs of the safety analysis set
Time Frame: Up to 48 Weeks
Type, frequency, seriousness, severity of AEs/treatment-related AEs of the safety analysis set will be collected
Up to 48 Weeks
AEs leading to interruption/discontinuation in the safety analysis set
Time Frame: Up to 48 Weeks
AEs leading to interruption/discontinuation in the safety analysis set will be collected
Up to 48 Weeks
Frequency of AEs/treatment-related AEs summarized by patient characteristic factor
Time Frame: Up to 48 Weeks
Frequency of AEs/treatment-related AEs summarized by patient characteristic factor will be collected
Up to 48 Weeks
Type, frequency, seriousness, severity of AEs/treatment-related AEs in patients with special characteristics
Time Frame: Up to 48 Weeks
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
AEs leading to interruption/discontinuation in patients with special characteristics
Time Frame: Up to 48 Weeks
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
Type, frequency, seriousness, severity and outcome of AEs/treatment-related AEs by treatment line
Time Frame: Up to 48 Weeks
Type, frequency, seriousness, severity and outcome of AEs/treatment-related AEs by treatment line will be collected
Up to 48 Weeks
Factors affecting occurrence of AEs by treatment line
Time Frame: Up to 48 Weeks
Factors affecting occurrence of AEs by treatment line will be collected
Up to 48 Weeks
AEs leading to interruption/discontinuation by treatment line
Time Frame: Up to 48 Weeks
AEs leading to interruption/discontinuation by treatment line will be collected
Up to 48 Weeks
Major molecular response (MMR) rates
Time Frame: Week 12, Week 24, Week 48

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
MMR rates by Week 48 by patient characteristics factor
Time Frame: Up to 48 Weeks

Major molecular response (MMR) is defined as BCR-ABL1 International Scale value ≤ 0.1%.

BCR-ABL1: translocation-produced fusion gene
Up to 48 Weeks
MR4.0 and MR4.5 rates
Time Frame: Week 12, Week 24 and Week 48

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
Complete cytogenetic response (CCyR) rates
Time Frame: Week 12, Week 24 and Week 48
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
Complete hematological response (CHR) rates
Time Frame: Week 12, Week 24 and Week 48

This study will collect complete hematological response (CHR), which is defined as meeting the following 6 criteria.

  1. White blood cell count < 10,000/µL
  2. Platelet count < 450,000/µL
  3. No blast cell and promyelocyte in peripheral blood
  4. Myelocyte + metamyelocyte in peripheral blood = 0%
  5. Basophil < 5%
  6. No spleen and liver swelling, and no extramedullary lesion
Week 12, Week 24 and Week 48
Rate of patients with BCR-ABL1 gene mutations
Time Frame: Up to 48 Weeks
This study will collect the rate of patients with BCR-ABL1 gene mutations
Up to 48 Weeks
MMR rates by Week 48 in patients with special characteristics
Time Frame: Week 48
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
MMR rates by treatment line
Time Frame: Week 12, Week 24 and Week 48
This study will collect major molecular response (MMR) rates by treatment line
Week 12, Week 24 and Week 48
MR4.0 and MR4.5 rates by treatment line
Time Frame: Week 12, Week 24 and Week 48

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
CCyR rates by treatment line
Time Frame: Week 12, Week 24 and Week 48
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
CHR rates by treatment line
Time Frame: Week 12, Week 24 and Week 48

This study will collect complete hematological response (CHR), which is defined as meeting the following 6 criteria.

  1. White blood cell count < 10,000/µL
  2. Platelet count < 450,000/µL
  3. No blast cell and promyelocyte in peripheral blood
  4. Myelocyte + metamyelocyte in peripheral blood = 0%
  5. Basophil < 5%
  6. No spleen and liver swelling, and no extramedullary lesion
Week 12, Week 24 and Week 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Investigators

  • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 4, 2022

Primary Completion (Actual)

February 29, 2024

Study Completion (Actual)

February 29, 2024

Study Registration Dates

First Submitted

June 13, 2022

First Submitted That Met QC Criteria

June 13, 2022

First Posted (Actual)

June 16, 2022

Study Record Updates

Last Update Posted (Actual)

March 27, 2024

Last Update Submitted That Met QC Criteria

March 26, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CABL001A1401

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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