AzTrials
AzTrials

Chronic Myeloid LeukemiaNCT05421091

Special Drug Use-results Surveillance of Scemblix Tablets

An observational study of Chronic Myeloid Leukemia, run by Novartis Pharmaceuticals at 278 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Uncontrolled, central registration system, all-case, multicenter, special drug use-results surveillance. Read more about this study

Who is it for?
Ages Up to 99 years
Conditions the study is for
Chronic Myeloid Leukemia
What is being tested?
Asciminib
How many people
550 participants
Where
278 sitesJapan
Study dates
4 Jul 2022to 29 Feb 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 99 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Patients treated with asciminib

Who may be able to join

  • patients treated with asciminib in Japan.

Who cannot join

  • NA

Trial locations and contacts

278 sites in 1 country.

278 sites in 1 country

Japan278 sites

  • Novartis Investigative Site

    Aizu-Wakamatsu, Fukushima, 969-3482

  • Novartis Investigative Site

    Akashi, Hyōgo, 673-8558

  • Novartis Investigative Site

    Akita, 010-8543

  • Novartis Investigative Site

    Amagasaki, Hyōgo, 660 8550

  • Novartis Investigative Site

    Amagasaki, Hyōgo, 660-8511

  • Novartis Investigative Site

    Anjo, Aichi-ken, 446-8602

  • Novartis Investigative Site

    Aomori, 030 8553

  • Novartis Investigative Site

    Asahikawa, Hokkaido, 078-8211

  • Novartis Investigative Site

    Asaka, Saitama, 351-0021

  • Novartis Investigative Site

    Bunkyo Ku, Tokyo, 113-8431

  • Novartis Investigative Site

    Bunkyo Ku, Tokyo, 113-8677

  • Novartis Investigative Site

    Bunkyo-ku, Tokyo, 113-8603

  • Novartis Investigative Site

    Chiba, 260-0852

  • Novartis Investigative Site

    Chiba, 260-8717

  • Novartis Investigative Site

    Chiba, 2608677

  • Novartis Investigative Site

    Chiyoda-ku, Tokyo, 101-8643

  • Novartis Investigative Site

    Chiyoda-ku, Tokyo, 102-8798

  • Novartis Investigative Site

    Chūō, Yamanashi, 409-3898

  • Novartis Investigative Site

    Fujioka, Gunma, 375-8503

  • Novartis Investigative Site

    Fukaya, Saitama, 366-0052

  • Novartis Investigative Site

    Fukuchiyama, Kyoto, 620-8505

  • Novartis Investigative Site

    Fukui, 910-0026

  • Novartis Investigative Site

    Fukui, 918-8503

  • Novartis Investigative Site

    Fukuoka, Fukuoka, 812-8582

  • Novartis Investigative Site

    Fukuoka, 812-0033

  • Novartis Investigative Site

    Fukuoka, 813-8501

  • Novartis Investigative Site

    Fukuoka, 815-8555

  • Novartis Investigative Site

    Fukuoka, 819-8585

  • Novartis Investigative Site

    Fukushima, Fukushima, 960 1295

  • Novartis Investigative Site

    Fukushima, 960-1101

  • Novartis Investigative Site

    Fukuyama, Hiroshima, 720-0001

  • Novartis Investigative Site

    Funabashi, Chiba, 273-8556

  • Novartis Investigative Site

    Gifu, Gifu, 501-1194

  • Novartis Investigative Site

    Gifu, 500-8717

  • Novartis Investigative Site

    Hachiōji, Tokyo, 192-0032

  • Novartis Investigative Site

    Hachiōji, Tokyo, 193-0944

  • Novartis Investigative Site

    Hakodate, Hokkaido, 041-0821

  • Novartis Investigative Site

    Hamamatsu, Shizuoka, 430-8558

  • Novartis Investigative Site

    Hamamatsu, Shizuoka, 431-3192

  • Novartis Investigative Site

    Hidaka, Saitama, 350-1298

  • Novartis Investigative Site

    Higashiibaraki-gun, Ibaraki, 311-3193

  • Novartis Investigative Site

    Himeji, Hyōgo, 670-8540

  • Novartis Investigative Site

    Hirakata, Osaka, 573-1191

  • Novartis Investigative Site

    Hiroshima, 730-8619

  • Novartis Investigative Site

    Hiroshima, 731-0232

  • Novartis Investigative Site

    Hiroshima, 731-5156

  • Novartis Investigative Site

    Hiroshima, 734-8551

  • Novartis Investigative Site

    Hitachi, Ibaraki, 317-0077

  • Novartis Investigative Site

    Ichihara, Chiba, 290-0003

  • Novartis Investigative Site

    Ichikawa, Chiba, 272-8513

  • Novartis Investigative Site

    Ichinomiya, Aichi-ken, 491-0041

  • Novartis Investigative Site

    Ikoma, Nara, 630-0293

  • Novartis Investigative Site

    Iruma-gun, Saitama, 350-0495

  • Novartis Investigative Site

    Isahaya, Nagasaki, 854-0071

  • Novartis Investigative Site

    Ishinomaki, Miyagi, 986-0861

  • Novartis Investigative Site

    Ishioka, Ibaraki, 315-0037

  • Novartis Investigative Site

    Iwaki, Fukushima, 973-8402

  • Novartis Investigative Site

    Iwamizawa, Hokkaido, 068-8555

  • Novartis Investigative Site

    Iwata, Shizuoka, 438-8550

  • Novartis Investigative Site

    Izumisano, Osaka, 598-8577

  • Novartis Investigative Site

    Izumo, Shimane, 693 8501

  • Novartis Investigative Site

    Izumo, Shimane, 693-0068

  • Novartis Investigative Site

    Izunokuni, Shizuoka, 410-2295

  • Novartis Investigative Site

    Jōetsu, Niigata, 943-0147

  • Novartis Investigative Site

    Kakogawa-shi, Hyōgo, 675-8611

  • Novartis Investigative Site

    Kamakura, Kanagawa, 247-8533

  • Novartis Investigative Site

    Kanazawa, Ishikawa-ken, 920-0853

  • Novartis Investigative Site

    Kanazawa, Ishikawa-ken, 920-8641

  • Novartis Investigative Site

    Kanoya, Kagoshima-ken, 893-0024

  • Novartis Investigative Site

    Karatsu, Saga-ken, 847-0000

  • Novartis Investigative Site

    Kashihara, Nara, 634 8522

  • Novartis Investigative Site

    Kashiwa, Chiba, 277 8577

  • Novartis Investigative Site

    Kashiwa, Chiba, 277-8567

  • Novartis Investigative Site

    Kasugai, Aichi-ken, 486-8510

  • Novartis Investigative Site

    Kawachi-Nagano, Osaka, 586-0008

  • Novartis Investigative Site

    Kawachi-Nagano, Osaka, 586-8521

  • Novartis Investigative Site

    Kawagoe, Saitama, 350 8550

  • Novartis Investigative Site

    Kawasaki, Kanagawa, 211-8510

  • Novartis Investigative Site

    Kawasaki, Kanagawa, 216-8511

  • Novartis Investigative Site

    Kawasaki, Kanagawa, 255

  • Novartis Investigative Site

    Kinokawa, Wakayama, 649-6414

  • Novartis Investigative Site

    Kirishima, Kagoshima-ken, 899-5112

  • Novartis Investigative Site

    Kisarazu, Chiba, 292-8535

  • Novartis Investigative Site

    Kita-gun, Kagawa-ken, 761-0793

  • Novartis Investigative Site

    Kitakami, Iwate, 024-0004

  • Novartis Investigative Site

    Kitakyushu, Fukuoka, 802-8555

  • Novartis Investigative Site

    Kitakyushu, Fukuoka, 806-8501

  • Novartis Investigative Site

    Kitakyushu, Fukuoka, 807-8556

  • Novartis Investigative Site

    Kobe, Hyōgo, 650-0017

  • Novartis Investigative Site

    Kobe, Hyōgo, 650-0047

  • Novartis Investigative Site

    Kobe, Hyōgo, 651-0072

  • Novartis Investigative Site

    Kobe, Hyōgo, 651-1145

  • Novartis Investigative Site

    Kobe, Hyōgo, 651-2273

  • Novartis Investigative Site

    Kobe, Hyōgo, 657-0064

  • Novartis Investigative Site

    Kochi, Kochi, 781 8555

  • Novartis Investigative Site

    Kofu, Yamanashi, 400-8506

  • Novartis Investigative Site

    Koga, Ibaraki, 306-0232

  • Novartis Investigative Site

    Komae, Tokyo, 201-8601

  • Novartis Investigative Site

    Komaki, Aichi-ken, 485-8520

  • Novartis Investigative Site

    Komatsushimachō, Tokushima, 773-8502

  • Novartis Investigative Site

    Kōnan, Aichi-ken, 483-8704

  • Novartis Investigative Site

    Koshigaya, Saitama, 343-8555

  • Novartis Investigative Site

    Koto Ku, Tokyo, 135 8550

  • Novartis Investigative Site

    Kumamoto, Kumamoto, 860-8556

  • Novartis Investigative Site

    Kumamoto, Kumamoto, 861-4193

  • Novartis Investigative Site

    Kumamoto, Kumamoto, 861-8520

  • Novartis Investigative Site

    Kumamoto, Kumamoto, 862-8655

  • Novartis Investigative Site

    Kurashiki, Okayama-ken, 710-8602

  • Novartis Investigative Site

    Kurume, Fukuoka, 830-8543

  • Novartis Investigative Site

    Kusatsu, Shiga, 525 8585

  • Novartis Investigative Site

    Kushiro, Hokkaido, 085-0052

  • Novartis Investigative Site

    Kyoto, Kyoto, 604-8845

  • Novartis Investigative Site

    Kyoto, 603-8151

  • Novartis Investigative Site

    Kyoto, 605-0981

  • Novartis Investigative Site

    Kyoto, 606 8507

  • Novartis Investigative Site

    Kyoto, 606-8273

  • Novartis Investigative Site

    Kyoto, 615-8256

  • Novartis Investigative Site

    Maebashi, Gunma, 371 8511

  • Novartis Investigative Site

    Maebashi, Gunma, 371-0811

  • Novartis Investigative Site

    Maebashi, Gunma, 371-0821

  • Novartis Investigative Site

    Maizuru, Kyoto, 625-0036

  • Novartis Investigative Site

    Masuda, Shimane, 698-0003

  • Novartis Investigative Site

    Matsudo, Chiba, 270-0034

  • Novartis Investigative Site

    Matsue, Shimane, 690-8506

  • Novartis Investigative Site

    Matsuyama, Ehime, 790-0024

  • Novartis Investigative Site

    Matsuyama, Ehime, 790-0067

  • Novartis Investigative Site

    Matsuyama, Ehime, 790-8524

  • Novartis Investigative Site

    Meguro City, Tokyo, 153-8581

  • Novartis Investigative Site

    Meguro-ku, Tokyo, 152-8902

  • Novartis Investigative Site

    Mihara, Hiroshima, 723-0014

  • Novartis Investigative Site

    Minamiuonuma, Niigata, 949-7302

  • Novartis Investigative Site

    Minato Ku, Tokyo, 105-8470

  • Novartis Investigative Site

    Minato-ku, Tokyo, 105-8471

  • Novartis Investigative Site

    Minato-ku, Tokyo, 108-8639

  • Novartis Investigative Site

    Mitaka, Tokyo, 181-8611

  • Novartis Investigative Site

    Miyakonojō, Miyazaki, 885-0014

  • Novartis Investigative Site

    Miyakonojō, Miyazaki, 885-0035

  • Novartis Investigative Site

    Miyazaki, 880-0041

  • Novartis Investigative Site

    Miyazaki, 880-8510

  • Novartis Investigative Site

    Moriguchi, Osaka, 570-8507

  • Novartis Investigative Site

    Moriguchi, Osaka, 570-8540

  • Novartis Investigative Site

    Morioka, Iwate, 020 0066

  • Novartis Investigative Site

    Moriyama, Shiga, 524-8524

  • Novartis Investigative Site

    Musashino, Tokyo, 180-8610

  • Novartis Investigative Site

    Nagahama, Shiga, 526-0831

  • Novartis Investigative Site

    Nagakute, Aichi-ken, 480-1195

  • Novartis Investigative Site

    Nagano, Nagano, 380-8582

  • Novartis Investigative Site

    Nagaoka, Niigata, 940-2085

  • Novartis Investigative Site

    Nagasaki, Nagasaki, 852-8511

  • Novartis Investigative Site

    Nagasaki, 850-8555

  • Novartis Investigative Site

    Nago, Okinawa, 905-0011

  • Novartis Investigative Site

    Nagoya, Aichi-ken, 453-8511

  • Novartis Investigative Site

    Nagoya, Aichi-ken, 457 8510

  • Novartis Investigative Site

    Nagoya, Aichi-ken, 460-0001

  • Novartis Investigative Site

    Nagoya, Aichi-ken, 466-8650

  • Novartis Investigative Site

    Nagoya, Aichi-ken, 467-8602

  • Novartis Investigative Site

    Naha, Okinawa, 902-8511

  • Novartis Investigative Site

    Nanao, Ishikawa-ken, 926-0866

  • Novartis Investigative Site

    Nara, 630-8305

  • Novartis Investigative Site

    Narita, Chiba, 286-8523

  • Novartis Investigative Site

    Nerima-ku, Tokyo, 113-0033

  • Novartis Investigative Site

    Niigata, 951 8520

  • Novartis Investigative Site

    Nishinomiya, Hyōgo, 662-0918

  • Novartis Investigative Site

    Nishinomiya, Hyōgo, 663 8501

  • Novartis Investigative Site

    Nishinomiya, Hyōgo, 663-8186

  • Novartis Investigative Site

    Nobeoka, Miyazaki, 882-0835

  • Novartis Investigative Site

    Nomi, Ishikawa-ken, 923-1226

  • Novartis Investigative Site

    Obihiro, Hokkaido, 080-0024

  • Novartis Investigative Site

    Ōdate, Akita, 017-8550

  • Novartis Investigative Site

    Ōita, 870-1133

  • Novartis Investigative Site

    Okayama, Okayama-ken, 700-8558

  • Novartis Investigative Site

    Okayama, Okayama-ken, 700-8607

  • Novartis Investigative Site

    Okayama, Okayama-ken, 701-1192

  • Novartis Investigative Site

    Okayama, 700-8557

  • Novartis Investigative Site

    Okuno, Tokushima, 771-0204

  • Novartis Investigative Site

    Ōme, Tokyo, 198-0042

  • Novartis Investigative Site

    Ōmihachiman, Shiga, 523-0082

  • Novartis Investigative Site

    Osaka, Osaka, 530-0012

  • Novartis Investigative Site

    Osaka, Osaka, 541-8567

  • Novartis Investigative Site

    Osaka, Osaka, 543-8555

  • Novartis Investigative Site

    Osaka, Osaka, 550-0006

  • Novartis Investigative Site

    Osaka, 534-0021

  • Novartis Investigative Site

    Osaka, 536-0001

  • Novartis Investigative Site

    Osaka, 540-0008

  • Novartis Investigative Site

    Osaka, 542-0081

  • Novartis Investigative Site

    Osaka, 543-8922

  • Novartis Investigative Site

    Osaka, 545-8586

  • Novartis Investigative Site

    Osaka, 553-0003

  • Novartis Investigative Site

    Ōsaka-sayama, Osaka, 589 8511

  • Novartis Investigative Site

    Ōta, Gunma, 373-8550

  • Novartis Investigative Site

    Saga, Saga-ken, 849-8501

  • Novartis Investigative Site

    Saitama, 330 8777

  • Novartis Investigative Site

    Saitama, 330-0074

  • Novartis Investigative Site

    Saitama, 336-0911

  • Novartis Investigative Site

    Sakata, Yamagata, 998-8501

  • Novartis Investigative Site

    Saku, Nagano, 3850051

  • Novartis Investigative Site

    Sano, Tochigi, 327-8511

  • Novartis Investigative Site

    Sapporo, Hokkaido, 003-0006

  • Novartis Investigative Site

    Sapporo, Hokkaido, 004-8618

  • Novartis Investigative Site

    Sapporo, Hokkaido, 007-0805

  • Novartis Investigative Site

    Sapporo, Hokkaido, 060-0004

  • Novartis Investigative Site

    Sapporo, Hokkaido, 060-8543

  • Novartis Investigative Site

    Sayama, Saitama, 350-1305

  • Novartis Investigative Site

    Sekimachi, Gifu, 501-3802

  • Novartis Investigative Site

    Sendai, Miyagi, 980 8574

  • Novartis Investigative Site

    Sendai, Miyagi, 982-0007

  • Novartis Investigative Site

    Sendai, Miyagi, 983 8512

  • Novartis Investigative Site

    Sendai, Miyagi, 983 8520

  • Novartis Investigative Site

    Seto, Aichi-ken, 489-8642

  • Novartis Investigative Site

    Shibata, Niigata, 957-8588

  • Novartis Investigative Site

    Shibuya City, Tokyo, 150-8935

  • Novartis Investigative Site

    Shimada, Shizuoka, 427-8502

  • Novartis Investigative Site

    Shimajiri-Gun, Okinawa, 901-1303

  • Novartis Investigative Site

    Shimotsuke, Tochigi, 329-0498

  • Novartis Investigative Site

    Shinagawa Ku, Tokyo, 141 8625

  • Novartis Investigative Site

    Shinagawa-ku, Tokyo, 142-8666

  • Novartis Investigative Site

    Shinjuku Ku, Tokyo, 162 8655

  • Novartis Investigative Site

    Shinjuku Ku, Tokyo, 162 8666

  • Novartis Investigative Site

    Shinjuku-ku, Tokyo, 160 8582

  • Novartis Investigative Site

    Shinjuku-ku, Tokyo, 160-0023

  • Novartis Investigative Site

    Shiwa-gun, Iwate, 028-3695

  • Novartis Investigative Site

    Shizuoka, Shizuoka, 420-8630

  • Novartis Investigative Site

    Suginami, Tokyo, 166-0001

  • Novartis Investigative Site

    Suita, Osaka, 564-0082

  • Novartis Investigative Site

    Suita, Osaka, 565 0871

  • Novartis Investigative Site

    Sumida-ku, Tokyo, 130-8575

  • Novartis Investigative Site

    Sumoto, Hyōgo, 656-0021

  • Novartis Investigative Site

    Sunto Gun, Shizuoka, 411 8777

  • Novartis Investigative Site

    Suwa, Nagano, 392-8510

  • Novartis Investigative Site

    tabashi City, Tokyo, 173 0015

  • Novartis Investigative Site

    tabashi City, Tokyo, 173 8606

  • Novartis Investigative Site

    Tachikawa, Tokyo, 190-8531

  • Novartis Investigative Site

    Takamatsu, Kagawa-ken, 760 8557

  • Novartis Investigative Site

    Takamatsu, Kagawa-ken, 760-0017

  • Novartis Investigative Site

    Takamatsu, Kagawa-ken, 761-8538

  • Novartis Investigative Site

    Takatsuki, Osaka, 569-1096

  • Novartis Investigative Site

    Takayama, Gifu, 506-8550

  • Novartis Investigative Site

    Tenri, Nara, 632-8552

  • Novartis Investigative Site

    Tochigi, 329-4407

  • Novartis Investigative Site

    Tōkai, Aichi-ken, 477-8522

  • Novartis Investigative Site

    Tokorozawa, Saitama, 359 8513

  • Novartis Investigative Site

    Tokorozawa, Saitama, 359-0037

  • Novartis Investigative Site

    Tokushima, 770-0812

  • Novartis Investigative Site

    Tonami, Toyama, 939-1343

  • Novartis Investigative Site

    Tondabayashi, Osaka, 584-0091

  • Novartis Investigative Site

    Tōon, Ehime, 791-0295

  • Novartis Investigative Site

    Toyama, Toyama, 930-0194

  • Novartis Investigative Site

    Toyama, Toyama, 939-8511

  • Novartis Investigative Site

    Toyama, 930-0859

  • Novartis Investigative Site

    Toyama, 930-8550

  • Novartis Investigative Site

    Toyoake, Aichi-ken, 470 1192

  • Novartis Investigative Site

    Toyohashi, Aichi-ken, 441-8111

  • Novartis Investigative Site

    Toyohashi, Aichi-ken, 441-8570

  • Novartis Investigative Site

    Toyonaka, Osaka, 560-8565

  • Novartis Investigative Site

    Toyooka, Hyōgo, 668-8501

  • Novartis Investigative Site

    Tsu, Mie-ken, 514-0057

  • Novartis Investigative Site

    Tsu, Mie-ken, 514-8507

  • Novartis Investigative Site

    Tsuchiura, Ibaraki, 300-0028

  • Novartis Investigative Site

    Tsukuba, Ibaraki, 300-2622

  • Novartis Investigative Site

    Tsukuba, Ibaraki, 305-8576

  • Novartis Investigative Site

    Tsuyama, Okayama-ken, 708-0841

  • Novartis Investigative Site

    Ube, Yamaguchi, 755-8505

  • Novartis Investigative Site

    Wakayama, 640-8558

  • Novartis Investigative Site

    Wakayama, 641-8510

  • Novartis Investigative Site

    Yamagata, 990-2214

  • Novartis Investigative Site

    Yamagata, 992-8502

  • Novartis Investigative Site

    Yamato, Kanagawa, 242-8602

  • Novartis Investigative Site

    Yanagawa, Fukuoka, 832-0059

  • Novartis Investigative Site

    Yatomi, Aichi-ken, 498-8502

  • Novartis Investigative Site

    Yokkaichi, Mie-ken, 510-8567

  • Novartis Investigative Site

    Yokohama, Kanagawa, 221-0855

  • Novartis Investigative Site

    Yokohama, Kanagawa, 227-8501

  • Novartis Investigative Site

    Yokohama, Kanagawa, 232 0024

  • Novartis Investigative Site

    Yokohama, Kanagawa, 236-0004

  • Novartis Investigative Site

    Yokohama, Kanagawa, 241-0811

  • Novartis Investigative Site

    Yonago, Tottori, 683-8504

  • Novartis Investigative Site

    Yoshida-gun, Fukui, 910-1193

  • Novartis Investigative Site

    Yufu, Oita Prefecture, 879-5593

Other trials in Japan

About this study

Official title: 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.

Read the 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.

Being tested
Asciminib
Keywords
chronic myeloid leukemia, CML, Scemblix Tablets, Asciminib, resistant or intolerant CML
Medical subject headings
Leukemia, Myelogenous, Chronic, BCR-ABL Positive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AsciminibOther

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

Study groups in NCT05421091
Study groupRoleWhat they receive
AsciminibPatients prescribed with Asciminib
Receives: Other: Asciminib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Up to 48 Weeks

  2. 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

    Measured: Up to 48 Weeks

  3. 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

    Measured: Up to 48 Weeks

  4. Frequency of AEs/Treatment-related AEs by patient characteristic factor

    Frequency of AEs/Treatment-related AEs by patient characteristic factor will be collected

    Measured: Up to 48 Weeks

Secondary outcomes (19)

  1. 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

    Measured: Up to 48 Weeks

  2. AEs leading to interruption/discontinuation in the safety analysis set

    AEs leading to interruption/discontinuation in the safety analysis set will be collected

    Measured: Up to 48 Weeks

  3. 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

    Measured: Up to 48 Weeks

  4. 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

    Measured: Up to 48 Weeks

  5. 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

    Measured: Up to 48 Weeks

  6. 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

    Measured: Up to 48 Weeks

  7. Factors affecting occurrence of AEs by treatment line

    Factors affecting occurrence of AEs by treatment line will be collected

    Measured: Up to 48 Weeks

  8. AEs leading to interruption/discontinuation by treatment line

    AEs leading to interruption/discontinuation by treatment line will be collected

    Measured: Up to 48 Weeks

  9. Major molecular response (MMR) rates

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

    BCR-ABL1: translocation-produced fusion gene

    Measured: Week 12, Week 24, Week 48

  10. 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

    Measured: Up to 48 Weeks

  11. 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

    Measured: Week 12, Week 24 and Week 48

  12. 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%.

    Measured: Week 12, Week 24 and Week 48

  13. Complete hematological response (CHR) rates

    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

    Measured: Week 12, Week 24 and Week 48

  14. Rate of patients with BCR-ABL1 gene mutations

    This study will collect the rate of patients with BCR-ABL1 gene mutations

    Measured: Up to 48 Weeks

  15. 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)

    Measured: Week 48

  16. MMR rates by treatment line

    This study will collect major molecular response (MMR) rates by treatment line

    Measured: Week 12, Week 24 and Week 48

  17. 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

    Measured: Week 12, Week 24 and Week 48

  18. 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%.

    Measured: Week 12, Week 24 and Week 48

  19. CHR rates by treatment line

    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

    Measured: Week 12, Week 24 and Week 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jun 2022
  2. Study start4 Jul 2022
  3. Primary completion29 Feb 2024
  4. Study completion29 Feb 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
550 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05421091
Sponsor's protocol ID
CABL001A1401
Status last verified
Mar 2024
First submitted
13 Jun 2022
Last updated
27 Mar 2024
Results posted
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Myeloid Leukemia, run by Novartis Pharmaceuticals at 278 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 278 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Type, frequency, seriousness and severity of adverse event (AE)/treatment-related AE of the safety specifications (time frame: Up to 48 Weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05421091.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2024.

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