Study of Oral Venetoclax Tablets to Evaluate Adverse Events and Change in Disease Activity in Participants of Any Age With Acute Myeloid Leukemia

April 24, 2025 updated by: AbbVie

A Post-marketing Observational Study for Venetoclax in Patients Diagnosed With Acute Myeloid Leukemia in Japan

Acute Myeloid Leukemia (AML) is an aggressive and rare cancer of myeloid cells (a white blood cell responsible for fighting infections) and is the most common acute leukemia in adults. This study will assess how safe and effective oral venetoclax is in participants with AML. Adverse events and change in disease activity will be monitored under routine clinical practice.

Venetoclax is an approved drug to treat Acute Myeloid Leukemia (AML). Around 400 participants of any age who are treated with oral venetoclax tablets for AML in accordance with the approved label will be enrolled in the study across Japan.

Participants will be followed up to 52 weeks following the first dose of oral venetoclax tablets.

There is expected to be no additional burden for participants in this study. Data will be collected by information provided by participating physicians based on routine medical records.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
424

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Japan
      • Chiba, Japan, 260-0027
        • Inoue Memorial Hospital /ID# 239351
      • Chiba, Japan, 260-0042
        • National Hospital Organization Chiba Medical Center /ID# 266755
      • Fujisawa-shi, Japan, 251-8550
        • Fujisawa City Hospital /ID# 239375
      • Fukuoka-shi, Japan, 812-0033
        • Harasanshin Hospital /ID# 240881
      • Hachinohe-shi, Japan, 039-1104
        • Hachinohe Red Cross Hospital /ID# 250850
      • Hachioji, Japan, 192-0032
        • Tokai University Hachioji Hospital /ID# 266804
      • Higashihiroshima-shi, Japan, 739-0041
        • Higashihiroshima Medical Center /ID# 250849
      • Hiroshima, Japan, 734-8530
        • Hiroshima Prefecture Hospital /ID# 252215
      • Ikeda, Japan, 563-0025
        • Ikeda City Hospital /ID# 266802
      • Kawaguchi-shi, Japan, 333-0833
        • Kawaguchi Municipal Medical Center /ID# 246080
      • Kitakyushu-shi, Japan, 800-0257
        • Kitakyusyu General Hospital /ID# 244212
      • Mitaka, Japan, 181-8611
        • Kyorin University - Mitaka Campus /ID# 243777
      • Saiki-shi, Japan, 876-0857
        • Nankai Medical Center /ID# 241914
      • Saitama, Japan, 336-8522
        • Saitama City Hospital /ID# 240567
      • Sakata-shi, Japan, 998-0828
        • Nihonkai General Hospital /ID# 242024
      • Tachikawa, Japan
        • Tachikawa Hospital /ID# 245878
      • Takatsuki, Japan, 569-1045
        • Takatsuki Red Cross Hospital /ID# 266756
      • Tokyo, Japan, 140-8522
        • Toshiba General Hospital /ID# 250294
      • Toyama, Japan, 939-8511
        • Toyama Hospital /ID# 243779
      • Yamagata, Japan, 9978515
        • Shonai Hospital /ID# 254514
    • Aichi
      • Anjo-shi, Aichi, Japan, 446-8602
        • Anjou Kousei Hospital /ID# 244213
      • Nagoya shi, Aichi, Japan, 467-8602
        • Nagoya City University Hospital /ID# 256177
      • Nagoya-shi, Aichi, Japan, 462-8508
        • Nagoya City West Medical Center /ID# 250844
      • Nagoya-shi, Aichi, Japan, 464-8681
        • Aichi Cancer Center Hospital /ID# 243785
      • Nagoya-shi, Aichi, Japan, 466-8650
        • Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital /ID# 242173
      • Nagoya-shi, Aichi, Japan, 4668560
        • Nagoya University Hospital /ID# 246009
      • Obu-shi, Aichi, Japan, 474-8511
        • National Center for Geriatrics and Gerontology /ID# 251683
      • Toyohashi-shi, Aichi, Japan, 441-8570
        • Toyohashi Municipal Hospital /ID# 243784
      • Toyokawa-shi, Aichi, Japan, 442-8561
        • Toyokawa City Hospital /ID# 242707
      • Toyota-shi, Aichi, Japan, 471-8513
        • Toyota Memorial Hospital /ID# 242175
    • Akita
      • Akita-shi, Akita, Japan, 010-0933
        • Akita city Hospital /ID# 240008
      • Odate-shi, Akita, Japan, 017-0885
        • Odate Municipal General Hospital /ID# 258238
    • Aomori
      • Aomori-shi, Aomori, Japan, 030-8553
        • Aomori Prefectural Central Hospital /ID# 249442
      • Hirosaki-shi, Aomori, Japan, 036-8545
        • National Hospital Organization Hirosaki General Medical Center /ID# 246008
    • Chiba
      • Asahi-shi, Chiba, Japan, 289-2511
        • Asahi General Hospital /ID# 233889
      • Chiba-shi, Chiba, Japan, 260-0852
        • Chiba Aoba Municipal Hospital /ID# 240565
      • Chiba-shi, Chiba, Japan, 260-8677
        • Chiba University Hospital /ID# 246011
      • Chiba-shi, Chiba, Japan, 260-8717
        • Duplicate_Chiba Cancer Center /ID# 248122
      • Ichihara City, Chiba, Japan, 290-0035
        • KK Clinic Ichihara /ID# 250859
      • Ichihara-shi, Chiba, Japan, 290-0003
        • Chiba Rosai Hospital /ID# 238767
      • Ichikawa-shi, Chiba, Japan, 272-0824
        • Tokyo Dental College Ichikawa General Hospital /ID# 262626
      • Inzai-shi, Chiba, Japan, 270-1613
        • Nippon Medical Chiba Hokusoh Hospital /ID# 250297
      • Kamogawa-shi, Chiba, Japan, 296-8602
        • Kameda General Hospital /ID# 241877
      • Kashiwa-shi, Chiba, Japan, 277-8567
        • The Jikei University Kashiwa Hospital /ID# 259510
      • Kashiwa-shi, Chiba, Japan, 277-8577
        • National Cancer Center Hospital East /ID# 241917
      • Kisarazu-shi, Chiba, Japan, 292-8535
        • Kimitsu Chuo Hospital /ID# 248776
      • Matsudo-shi, Chiba, Japan, 270-2251
        • Chiba West General Hospital /ID# 262918
      • Narashino-shi, Chiba, Japan, 275-0026
        • Tsudanuma Central General Hospital /ID# 245890
      • Narita-shi, Chiba, Japan, 286-8523
        • Japanese Red Cross Narita Hospital /ID# 243775
      • Narita-shi, Chiba, Japan, 2868520
        • IUHW Narita Hospital /ID# 240574
      • Narshino-shi, Chiba, Japan, 275-8580
        • Chibaken Saiseikai Narashino Hospital /ID# 254491
      • Sakura-shi, Chiba, Japan, 285-8741
        • Toho University Sakura Medical Center /ID# 252187
    • Ehime
      • Matsuyama City, Ehime, Japan, 108-0073
        • Watanabe Hospital /ID# 254476
      • Matsuyama-shi, Ehime, Japan, 790-0024
        • Ehime Prefectural Central Hospital /ID# 261348
      • Matsuyama-shi, Ehime, Japan, 790-0067
        • Matsuyama Shimin Hospital /ID# 243050
      • Matsuyama-shi, Ehime, Japan, 791-0280
        • National Hospital Organization Shikoku Cancer Center /ID# 242171
      • Toon-shi, Ehime, Japan, 791-0295
        • Ehime University Hospital /ID# 244207
    • Fukui
      • Fukui-shi, Fukui, Japan, 918-8503
        • Fukuiken Saiseikai Hospital /ID# 245062
      • Fukui-shi, Fukui, Japan, 918-8503
        • Fukuiken Saiseikai Hospital /ID# 246005
    • Fukuoka
      • Fukuoka shi, Fukuoka, Japan, 810-8563
        • National Hospital Organization Kyushu Medical Center /ID# 242026
      • Fukuoka-shi, Fukuoka, Japan, 810-0001
        • Saiseikai Fukuoka Genaral Hospital /ID# 255193
      • Fukuoka-shi, Fukuoka, Japan, 811-0213
        • Fukuoka Wajiro Hospital /ID# 238755
      • Fukuoka-shi, Fukuoka, Japan, 811-1395
        • National Hospital Organization Kyushu Cancer Center /ID# 244217
      • Fukuoka-shi, Fukuoka, Japan, 812-8582
        • Kyushu University Hospital /ID# 248781
      • Fukuoka-shi, Fukuoka, Japan, 814-0180
        • Fukuoka University Hospital /ID# 244214
      • Fukuoka-shi, Fukuoka, Japan, 815-8555
        • Japanese Red Cross Fukuoka Hospital /ID# 241181
      • Fukuoka-shi, Fukuoka, Japan, 819-0032
        • Murakami Karindoh Hospital /ID# 256179
      • Iizuka, Fukuoka, Japan, 820-8505
        • Aso Iizuka Hospital /ID# 266806
      • Kitakyusyu-shi, Fukuoka, Japan, 802-8533
        • NHO Kokura Medical Center /ID# 257008
      • Kitakyusyu-shi, Fukuoka, Japan, 808-0024
        • Wakamatsu Hospital /ID# 251728
      • Kurume City, Fukuoka, Japan, 830-0033
        • Shinkoga Hospital /ID# 248786
      • Kurume-shi, Fukuoka, Japan, 830-0011
        • Kurume University Hospital /ID# 240885
      • Kurume-shi, Fukuoka, Japan, 830-8543
        • St. Mary's Hospital /ID# 242332
      • Omuta-shi, Fukuoka, Japan, 836-0861
        • Omuta City Hospital /ID# 246823
      • Yanagawa-shi, Fukuoka, Japan, 832-0059
        • Nagata Hospital /ID# 256180
    • Fukushima
      • Date-shi, Fukushima, Japan, 960-0502
        • Kita Fukushima Medical Center /ID# 250296
      • Fukushima-shi, Fukushima, Japan, 960-8163
        • Fukushima Minami Cardiovascular Hospital /ID# 252216
      • Iwaki-shi, Fukushima, Japan, 972-8322
        • Tokiwakai Jyoban Hospital /ID# 257007
      • Iwaki-shi, Fukushima, Japan, 973-8555
        • Iwaki Kyoritsu General Hospital /ID# 260209
      • Koriyama-shi, Fukushima, Japan, 963-8558
        • Ohta Nishinouchi Hospital /ID# 243052
      • Shirakawa-shi, Fukushima, Japan, 961-0005
        • Shirakawa Kosei General Hosp. /ID# 245815
    • Gifu
      • Gifu-shi, Gifu, Japan, 500-8513
        • Gifu Municipal Hospital /ID# 241156
      • Gifu-shi, Gifu, Japan, 501-1194
        • Gifu University Hospital /ID# 241183
      • Gifu-shi, Gifu, Japan, 502-8511
        • Gifu Red Cross Hospital /ID# 240562
      • Ogaki-shi, Gifu, Japan, 503-8502
        • Ogaki Municipal Hospital /ID# 239353
      • 高山市, Gifu, Japan, 506-0025
        • Japanese Red Cross Takayama Hospital /ID# 240568
    • Gunma
      • Fujioka-shi, Gunma, Japan, 375-0015
        • Fujioka General Hospital /ID# 255196
      • Maebashi-shi, Gunma, Japan, 371-0821
        • Gunmaken Saiseikai Maebashi Hospital /ID# 239383
      • Ota-shi, Gunma, Japan, 373-8550
        • Gunma Prefectural Cancer Center /ID# 242177
      • Shibukawa-shi, Gunma, Japan, 377-0280
        • National Hospital Organization Shibukawa Medical Center /ID# 245026
      • Tatebayashi-shi, Gunma, Japan, 374-0055
        • Tatebayashi Kosei General Hospital /ID# 252188
    • Hiroshima
      • Hiroshima-shi, Hiroshima, Japan, 730-8619
        • Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital /ID# 240880
      • Mihara, Hiroshima, Japan, 723-0014
        • Mihara Shiromachi Hospital /ID# 246754
      • Otake-shi, Hiroshima, Japan, 739-0696
        • NHO Hiroshima-Nishi Medical center /ID# 238766
    • Hokkaido
      • Kitami-shi, Hokkaido, Japan, 090-0026
        • Kitami Red Cross Hospital /ID# 251065
      • Muroran-shi, Hokkaido, Japan, 050-0076
        • Steel Memorial Muroran Hospita /ID# 231383
      • Obihiro-shi, Hokkaido, Japan, 080-0024
        • Obihiro kosei Hospital /ID# 252218
      • Sapporo, Hokkaido, Japan, 003-0803
        • Homecareclinicn-Consept /Id# 239377
      • Sapporo, Hokkaido, Japan, 065-0012
        • Tenshi Hospital /ID# 243051
      • Sapporo-shi, Hokkaido, Japan, 003-0006
        • Sapporo Hokuyu Hospital /ID# 250856
      • Sapporo-shi, Hokkaido, Japan, 003-0804
        • Hokkaido Cancer Center /ID# 249441
      • Sapporo-shi, Hokkaido, Japan, 004-0052
        • Sapporo Hokushin Hospital /ID# 241878
      • Sapporo-shi, Hokkaido, Japan, 060-0033
        • Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 249446
      • Sapporo-shi, Hokkaido, Japan, 060-8543
        • Sapporo Medical University Hospital /ID# 252217
      • Sapporo-shi, Hokkaido, Japan, 060-8648
        • Hokkaido University Hospital /ID# 244223
      • Sapporo-shi, Hokkaido, Japan, 064-0804
        • Aiiku Hospital /ID# 239047
      • Sunagawa, Hokkaido, Japan, 073-0164
        • Sunagawa City Medical Center /ID# 239382
      • Wakkanai City, Hokkaido, Japan, 097-0022
        • Wakkanai City Hospital /ID# 243782
      • 札幌市, Hokkaido, Japan, 004-0831
        • Sapporo Kiyota Hospital /ID# 231385
    • Hyogo
      • Ako-shi, Hyogo, Japan, 678-0241
        • Ako Central Hospital /ID# 239721
      • Amagasaki-shi, Hyogo, Japan, 660-8550
        • Hyogo Prefectural Amagasaki General Medical Center /ID# 239355
      • Itami-shi, Hyogo, Japan, 6640006
        • Itami City Hospital /ID# 233888
      • Kobe-shi, Hyogo, Japan, 650-0047
        • Hyogo Prefectural Kobe Children's Hospital /ID# 245817
      • Kobe-shi, Hyogo, Japan, 650-0047
        • Kobe City Medical Center General Hospital /ID# 246010
      • Kobe-shi, Hyogo, Japan, 651-0072
        • Shinko Hospital /ID# 233782
      • Kobe-shi, Hyogo, Japan, 658-0064
        • Konan Medical Center /ID# 246079
      • Nishinomiya-shi, Hyogo, Japan, 662-0918
        • Hyogo?Prefectural?Nishinomiya Hospital /ID# 239354
      • Nishinomiya-shi, Hyogo, Japan, 663-8501
        • Hyogo Medical University Hospital /ID# 240569
      • Ono-shi, Hyogo, Japan, 675-1327
        • Kita-harima Medical Center /ID# 254490
      • Tamba-shi, Hyogo, Japan, 669-3464
        • Hyogo Prefectural Tamba Medical Center /ID# 240884
      • Tanbasasayama-shi, Hyogo, Japan, 669-2321
        • Hyogo College of Medicine Sasayama Medical Center /ID# 240888
      • 洲本市, Hyogo, Japan, 656-0021
        • Hyogo Prefectural Awaji Medical Center /ID# 240823
    • Ibaraki
      • Higashi Ibaraki-gun, Ibaraki, Japan, 311-3193
        • National Hospital Organization Mito Medical Center /ID# 239719
      • Hitachi-shi, Ibaraki, Japan, 317-0077
        • Hitachi General Hospital /ID# 239376
      • Toride-shi, Ibaraki, Japan, 302-0022
        • JA Toride Medical Center /ID# 240573
      • Tsukuba-shi, Ibaraki, Japan, 305-8576
        • University of Tsukuba Hospital /ID# 242023
    • Ishikawa
      • Kanazawa-Shi, Ishikawa, Japan, 920-0013
        • JCHO Kanazawa Hospital /ID# 239379
    • Iwate
      • Oshu-shi, Iwate, Japan, 0230864
        • Iwate Prefectural Isawa Hospital /ID# 246819
      • Shiwa-gun, Iwate, Japan, 028-3695
        • Iwate Medical University Hospital /ID# 251009
    • Kagawa
      • Sakaide City, Kagawa, Japan, 7620043
        • Sakaide City Hospital /ID# 240563
    • Kagoshima
      • Kagoshima-shi, Kagoshima, Japan, 890-0051
        • Imakiire General Hospital /ID# 258237
      • Kagoshima-shi, Kagoshima, Japan, 890-0064
        • Imamura General Hospital /ID# 234006
      • Kanoya-shi, Kagoshima, Japan, 893-0024
        • Medical Corporation Seijinkai Ikeda Hospital /ID# 242174
    • Kanagawa
      • CHIGASAKI-shi, Kanagawa, Japan, 253-0083
        • Shonan Tobu Sogo Hospital /ID# 241913
      • Kamakura-shi, Kanagawa, Japan, 247-8533
        • Shonan Kamakura General Hospital /ID# 243053
      • Kawasaki, Kanagawa, Japan, 213-8507
        • Teikyo University Mizonokuchi Hospital /ID# 244842
      • Kawasaki-shi, Kanagawa, Japan, 2100013
        • Kawasaki Municipal Hospital /ID# 241162
      • Kawasaki-shi, Kanagawa, Japan, 211-8510
        • Japan Organization of Occupational Health and Society Kanto Rosai Hospital /ID# 255195
      • Kawasaki-shi, Kanagawa, Japan, 213-8587
        • Toranomon Hospital Kajigaya /ID# 256186
      • Yokohama, Kanagawa, Japan, 241-0811
        • St. Marianna University School of Medicine Yokohama City Seibu Hospital /ID# 266803
      • Yokohama shi, Kanagawa, Japan, 232-0024
        • Yokohama City University Medical Center /ID# 248777
      • Yokohama-shi, Kanagawa, Japan, 234-8503
        • Saiseikai Yokohamashi Nanbu Hospital /ID# 247955
      • Yokohama-shi, Kanagawa, Japan, 241-8515
        • Kanagawa Cancer Center /ID# 246822
    • Kochi
      • 高知市, Kochi, Japan, 781-0111
        • Kochi Health Sciences Center /ID# 241182
    • Kumamoto
      • Kumamoto shi, Kumamoto, Japan, 8608556
        • Kumamoto University Hospital /ID# 239720
      • Kumamoto-shi, Kumamoto, Japan, 860-0008
        • National Hospital Organization Kumamoto Medical Center /ID# 240886
      • Kumamoto-shi, Kumamoto, Japan, 862-8655
        • Kumamoto Shinto General Hospital /ID# 242176
      • Kumamoto-shi,Kumamoto, Kumamoto, Japan, 862-8505
        • Kumamoto City Hospital /ID# 254494
      • Tamana-shi, Kumamoto, Japan, 865-0005
        • Kumamoto Kenhoku Hospital /ID# 258240
      • Uki, Kumamoto, Japan, 869-0524
        • Kumamoto Minami National Hospital /ID# 242169
      • Yatsushiro City, Kumamoto, Japan, 866-0856
        • JCHO Kumamoto General Hospital /ID# 248779
    • Kyoto
      • Kyoto-shi, Kyoto, Japan, 602-8566
        • University Hospital Kyoto Prefectural University of Medicine /ID# 244843
      • Kyoto-shi, Kyoto, Japan, 603-8151
        • JCHO Kyoto Kuramaguchi Medical /ID# 248775
      • Kyoto-shi, Kyoto, Japan, 605-0981
        • Japanese Red Cross Kyoto Daiichi Hosital /ID# 248124
      • Kyoto-shi, Kyoto, Japan, 606-8507
        • Kyoto University Hospital /ID# 244844
      • Kyoto-shi, Kyoto, Japan, 612-8555
        • National Hospital Organization Kyoto Medical Center /ID# 239092
      • Uji-shi, Kyoto, Japan, 611-0042
        • Uji Tokushukai Medical Center /ID# 241876
    • Mie
      • 津市, Mie, Japan, 514-0031
        • Takeuchi Hospital /ID# 238750
    • Miyagi
      • Natori-shi, Miyagi, Japan, 981-1293
        • Miyagi Cancer Center /ID# 241879
      • Osaki-shi, Miyagi, Japan, 989-6183
        • Osaki Citizen Hospital /ID# 249447
      • Sendai-shi, Miyagi, Japan, 980-0011
        • Miyagi Chuo Hospital /ID# 259511
      • Sendai-shi, Miyagi, Japan, 9808574
        • Tohoku University Hospital /ID# 243757
      • Sendai-shi, Miyagi, Japan, 983-8520
        • National Hospital Organization Sendai Medical Center /ID# 239384
    • Miyazaki
      • Miyazaki-shi, Miyazaki, Japan, 880-8510
        • Miyazaki Prefectural Miyazaki Hospital /ID# 251730
      • Miyazaki-shi, Miyazaki, Japan, 8800041
        • Koga General Hospital /ID# 248120
      • Miyazaki-shi, Miyazaki, Japan, 889-1692
        • University of Miyazaki Hospital /ID# 248805
      • Nabeoka-shi, Miyazaki, Japan, 882-0835
        • Miyazaki Prefectural Nobeoka Hospital /ID# 248715
    • Nagasaki
      • Goto-shi, Nagasaki, Japan, 853-0031
        • Nagasaki Goto Chuoh Hospital /ID# 239723
      • Nagasaki-shi, Nagasaki, Japan, 852-8104
        • Jap Red Cross Nagasaki Genbaku /ID# 245029
      • Nagasaki-shi, Nagasaki, Japan, 852-8501
        • Nagasaki University Hospital /ID# 245028
      • Omura-shi, Nagasaki, Japan, 856-8562
        • NHO Nagasaki Medical Center /ID# 240571
      • Sasebo-shi, Nagasaki, Japan, 857-0056
        • Sasebo City General Hospital /ID# 238759
    • Nara
      • Ikoma-shi, Nara, Japan, 630-0227
        • Nara Hospital Kinki University Faculty of Medicine, /ID# 250295
      • Kashihara-shi, Nara, Japan, 634-8522
        • Nara Medical University Hospital /ID# 251726
      • Nara-shi, Nara, Japan, 630-8054
        • Nara Prefecture General Medical Center /ID# 254492
      • Tenri-shi, Nara, Japan, 632-8552
        • Tenri Hospital /ID# 250855
    • Niigata
      • Niigata-shi, Niigata, Japan, 951-8520
        • Niigata University Medical & Dental Hospital /ID# 245027
    • Oita
      • Beppu-shi, Oita, Japan, 874-0011
        • National Hospital Organization Beppu Medical Center /ID# 247894
      • Beppu-shi, Oita, Japan, 874-0838
        • Kyushu University Beppu Hospital /ID# 249444
      • Oita City, Oita, Japan, 870-1133
        • Almeida Memorial Hospital /ID# 241916
      • Oita-shi, Oita, Japan, 870-0854
        • Oita Memorial Hospital /ID# 246818
      • Oita-shi, Oita, Japan, 870-0855
        • Oita Prefectural Hospital /ID# 243786
      • Yufu City, Oita, Japan, 879-5503
        • Oita University Hospital /ID# 261976
    • Okayama
      • Kurashiki-shi, Okayama, Japan, 701-0192
        • Kawasaki Medical School Hospital /ID# 242709
      • Kurashiki-shi, Okayama, Japan, 710-8602
        • Kurashiki Central Hospital /ID# 244205
      • Maniwa, Okayama, Japan, 719-3105
        • Kaneda Hospital /ID# 238757
      • Okayama-shi, Okayama, Japan, 700-8558
        • Duplicate_Okayama University Hospital /ID# 240887
      • Okayama-shi, Okayama, Japan, 700-8558
        • Duplicate_Okayama University Hospital /ID# 243755
      • Okayama-shi, Okayama, Japan, 700-8607
        • Japanese Red Cross Okayama Hospital /ID# 240879
      • Okayama-shi, Okayama, Japan, 701-1192
        • Okayama Medical Center /ID# 243759
    • Okinawa
      • Naha, Okinawa, Japan, 902-0061
        • Naha City Hospital /ID# 242027
      • Nakagami-gun, Okinawa, Japan, 903-0215
        • University of the Ryukyus Hospital /ID# 246821
      • Okinawa-shi, Okinawa, Japan, 904-2195
        • Nakagami Hospital /ID# 243787
    • Osaka
      • Habikino-shi, Osaka, Japan, 583-0872
        • Shiroyama Hospital /ID# 246762
      • Hirakata-shi, Osaka, Japan, 573-1191
        • Kansai Medical University Hospital /ID# 246820
      • Izumi-Shi, Osaka, Japan, 594-1101
        • Osaka Women's and Children's Hospital /ID# 266805
      • Izumi-shi, Osaka, Japan, 594-0073
        • Izumi City General Hospital /ID# 253204
      • Kishiwada-shi, Osaka, Japan, 596-8501
        • Kishiwada City Hospital /ID# 234002
      • Kita-ku, Osaka, Japan, 530-0005
        • Sumitomo Hospital /ID# 243774
      • Neyagawa City, Osaka, Japan, 572-0022
        • Seijukai Hospital /ID# 248788
      • Osaka-shi, Osaka, Japan, 530-0012
        • Osaka Saiseikai Nakatsu Hospital /ID# 244209
      • Osaka-shi, Osaka, Japan, 530-8480
        • Kitano Hospital /ID# 248785
      • Osaka-shi, Osaka, Japan, 534-0021
        • Osaka City General Hospital /ID# 244210
      • Osaka-shi, Osaka, Japan, 540-0006
        • National Hospital Organization Osaka National Hospital /ID# 238764
      • Osaka-shi, Osaka, Japan, 540-0008
        • Otemae Hospital /ID# 250857
      • Osaka-shi, Osaka, Japan, 541-8567
        • Osaka International Cancer Institute /ID# 248783
      • Osaka-shi, Osaka, Japan, 543-8555
        • Japanese Red Cross Osaka Hospi /ID# 248784
      • Osaka-shi, Osaka, Japan, 543-8922
        • Daini Osaka Police Hospital /ID# 240560
      • Osaka-shi, Osaka, Japan, 545-8586
        • Osaka Metropolitan University Hospital /ID# 253203
      • Osaka-shi, Osaka, Japan, 550-0006
        • Nippon Life Saiseikai Public Interest Foundation Nippon Life Hospital /ID# 243783
      • Osakasayama-shi, Osaka, Japan, 589-8511
        • Kindai University Hospital /ID# 250851
      • Takatsuki-shi, Osaka, Japan, 569-8686
        • Osaka Medical and Pharmaceutical University Hospital /ID# 249440
      • Yao City, Osaka, Japan, 581-0011
        • Yao Tokushukai General Hospital /ID# 247884
      • 東大阪市, Osaka, Japan, 579-8026
        • Ishikiriseiki Hospital /ID# 246077
      • 泉大津市, Osaka, Japan, 595-0006
        • Hara Hospital /ID# 244846
    • Saga
      • Saga-shi, Saga, Japan, 840-8571
        • Saga Medical Center Koseikan /ID# 245816
    • Saitama
      • Ageo-shi, Saitama, Japan, 362-8588
        • Ageo Central General Hospital /ID# 254515
      • Asaka-shi, Saitama, Japan, 351-0023
        • TMG Asaka Medical Center /ID# 238761
      • Fujimino City, Saitama, Japan, 356-0011
        • Kamifukuoka General Hospital /ID# 247890
      • Kuki-shi, Saitama, Japan, 346-0021
        • Shinkuki General Hospital /ID# 254516
      • Saitama-shi, Saitama, Japan, 331-0054
        • Saitama Citizens Medical Center /ID# 252573
      • Wako-shi, Saitama, Japan, 351-0102
        • NHO Saitama National Hospital /ID# 245061
    • Shiga
      • Kusatsu-shi, Shiga, Japan, 525-0066
        • Omi Medical Center /ID# 258233
      • Ritto, Shiga, Japan, 520-3046
        • Saiseikai Shiga Hospital /ID# 239381
    • Shimane
      • Hamada City, Shimane, Japan, 697-0022
        • National Hospital Organization Hamada Medical Center /ID# 250858
      • Izumo-shi, Shimane, Japan, 693-8501
        • Shimane University Hospital /ID# 255194
      • Izumo-shi, Shimane, Japan, 693-8555
        • Shimane Prefectural Central Ho /ID# 247895
      • Masuda-shi, Shimane, Japan, 698-0003
        • Masuda Red Cross Hospital /ID# 248780
    • Shizuoka
      • Shizuoka-shi, Shizuoka, Japan, 422-8527
        • Shizuoka Saiseikai Genaral Hospital /ID# 239722
    • Tochigi
      • Shimotsuga-gun, Tochigi, Japan, 321-0293
        • Duplicate_Dokkyo Medical University Hospital /ID# 246764
      • Shimotsuke City, Tochigi, Japan, 329-0502
        • Ishibashi General Hospital /ID# 243762
      • Utsunomiya-shi, Tochigi, Japan, 320-0834
        • Tochigi Cancer Center /ID# 249445
    • Tokushima
      • Anan-shi, Tokushima, Japan, 774-0045
        • Anan Medical Center /ID# 243781
      • Naruto-shi, Tokushima, Japan, 772-0001
        • Tokushima Prefecture Naruto Hospital /ID# 239095
      • Tokushima-shi, Tokushima, Japan, 770-8503
        • Tokushima University Hospital /ID# 252572
    • Tokyo
      • Bei Qu, Tokyo, Japan, 114-0001
        • Meirikai Chuo General Hospital /ID# 238751
      • Bunkyo-ku, Tokyo, Japan, 113-8431
        • Juntendo University Hospital /ID# 239096
      • Bunkyo-ku, Tokyo, Japan, 113-8519
        • Tokyo Medical And Dental University Hospital /ID# 242178
      • Chuo-ku, Tokyo, Japan, 104-8560
        • St.Luke's International Hospital /ID# 248787
      • Edogawa Ward, Tokyo, Japan, 133-0052
        • Medical Plaza Edogawa /ID# 244220
      • Edogawa-ku, Tokyo, Japan, 133-0052
        • Edogawa Hospital /ID# 239352
      • Fuchu, Tokyo, Japan, 183-8524
        • Tama Medical Center /ID# 247954
      • Fuchu City, Tokyo, Japan, 183-8524
        • Tokyo Metropolitan Children's Medical Center /ID# 252189
      • Fussa, Tokyo, Japan, 1970012
        • Fussa Hospital /ID# 240570
      • Higashimurayama-shi, Tokyo, Japan, 189-8511
        • Tama-Hokubu Medical Center /ID# 245879
      • Itabashi-ku, Tokyo, Japan, 173-0015
        • Tokyo Metropolitan Geriatric /ID# 249448
      • Itabashi-ku, Tokyo, Japan, 173-8606
        • Duplicate_Teikyo University Hospital /ID# 247896
      • Kodaira, Tokyo, Japan, 187-8510
        • Showa General Hospital /ID# 258235
      • Koto-ku, Tokyo, Japan, 135-8550
        • Duplicate_The Cancer Institute Hospital Of JFCR /ID# 244216
      • Meguro-ku, Tokyo, Japan, 153-0051
        • Mishuku Hospital /ID# 239378
      • Meguro-ku, Tokyo, Japan, 1538581
        • Kosei Chuo General Hospital /ID# 251011
      • Minato-ku, Tokyo, Japan, 105-8470
        • Toranomon Hospital /ID# 251010
      • Musashino-shi, Tokyo, Japan, 180-8610
        • Japanese Red Cross Musashino Hospital /ID# 246765
      • Nerima-ku, Tokyo, Japan, 177-0033
        • Juntendo Univ Nerima Hospital /ID# 250292
      • Ome, Tokyo, Japan, 198-0042
        • P_Ome Municipal General Hospital /ID# 248778
      • Setagaya Ward, Tokyo, Japan, 156-0052
        • Metropolitan Research and Treatment Center for Blood Disorders /ID# 231384
      • Setagaya-ku, Tokyo, Japan, 157-8535
        • National Center for Child Health and Development /ID# 243778
      • Shibuya-ku, Tokyo, Japan, 150-8935
        • Japanese Red Cross Medical Center /ID# 239385
      • Shinagawa-ku, Tokyo, Japan, 141-8625
        • NTT Medical Center Tokyo /ID# 240566
      • Shinjuku-ku, Tokyo, Japan, 160-0023
        • Tokyo Medical University Hospital /ID# 252571
      • Shinjuku-ku, Tokyo, Japan, 162-8655
        • Center hospital of the National Center for Global Health and Medicine /ID# 256189
      • Suginami-ku, Tokyo, Japan, 166-8588
        • Kawakita General Hospital /ID# 257009
      • Sumida-ku, Tokyo, Japan, 130-8575
        • Tokyo Metropolitan Bokutoh Hospital /ID# 241912
      • Sumida-ku, Tokyo, Japan, 1308587
        • The Fraternity Memorial Hospital /ID# 251685
      • Taito, Tokyo, Japan, 110-0015
        • Eiju General Hospital /ID# 243763
      • 板橋区, Tokyo, Japan, 173-0015
        • Toshima Hospital /ID# 240878
    • Tottori
      • Tottori-shi, Tottori, Japan, 680-0901
        • Tottori Prefectural Central Ho /ID# 245877
      • Yonago-shi, Tottori, Japan, 683-0006
        • Yonago Medical Center /ID# 240572
      • Yonago-shi, Tottori, Japan, 683-8504
        • Tottori University Hospital /ID# 244215
    • Toyama
      • Kurobe-shi, Toyama, Japan, 938-8502
        • Kurobe City Hospital /ID# 254493
    • Wakayama
      • Kinokawa City, Wakayama, Japan, 649-6414
        • Naga municipal Hospital /ID# 250259
      • Tanabe-shi, Wakayama, Japan, 646-0011
        • Social Insurance Kinan Hosp /ID# 251684
      • Wakayama-shi, Wakayama, Japan, 640-8505
        • Wakayama Rosai Hospital /ID# 250293
      • 海南市, Wakayama, Japan, 642-0002
        • Kainan Medical Center /ID# 240825
    • Yamagata
      • Higashiokitama-gun, Yamagata, Japan, 992-0601
        • Okitama Public General Hospital /ID# 242710
      • Yamagata-shi, Yamagata, Japan, 990-9585
        • Yamagata University Hospital /ID# 246763
    • Yamaguchi
      • Iwakuni-shi, Yamaguchi, Japan, 740-8510
        • NHO Iwakuni Clinical Center /ID# 242170
      • Shunan-shi, Yamaguchi, Japan, 745-8522
        • Tokuyama Central Hospital /ID# 242380
      • Ube-shi, Yamaguchi, Japan, 755-8505
        • Yamaguchi University Hospital /ID# 245060
      • Yamaguchi City, Yamaguchi, Japan, 754-0002
        • Ogori Daiichi General Hospital /ID# 246761
    • Yamanashi
      • Chuo-shi, Yamanashi, Japan, 409-3821
        • University of Yamanashi Hospital /ID# 246006

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Participants who are prescribed venetoclax for the treatment of Acute Myeloid Leukemia (AML) in routine clinical practice across Japan.

Description

Inclusion Criteria:

- All participants who are administered venetoclax for treatment of AML.

Exclusion Criteria:

None

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Participants Treated With Venetoclax
Participants who are administrated venetoclax for treatment of AML under routine clinical practice.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With ≥ Grade 3 Neutropenia of Venetoclax Regimens With Unfit Acute Myeloid Leukemia (AML)
Time Frame: Up to 52 weeks.
Percentage of participants with a high grade (≥ Grade 3) protocol specified neutropenia during and after treatment with venetoclax.
Up to 52 weeks.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Febrile Neutropenia and Thrombocytopenia
Time Frame: Up to 52 weeks
Percentage of participants with protocol specified febrile neutropenia and thrombocytopenia during and after treatment with venetoclax.
Up to 52 weeks
Percentage of Participants With Tumor Lysis Syndrome (TLS)
Time Frame: Up to 52 weeks
Percentage of participants with protocol specified TLS during and after treatment with venetoclax.
Up to 52 weeks
Percentage of Participants Reported >= Grade 3 Adverse Events (AE)/Adverse Drug Reactions (ADR)
Time Frame: Up to 52 weeks
Grade 3 and above AE/ADR are serious adverse event (SAE) that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above.
Up to 52 weeks
Percentage of Participants Reported Adverse Events (AE)/Adverse Drug Reaction (ADR)
Time Frame: Up to 52 weeks
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either definitely related, probably related, possibly related or unrelated.
Up to 52 weeks
Percentage of Participants With AE/ADR When Used Concomitantly With CYP3A Inhibitors or Growth Colony Stimulating Factor (G-CSF)
Time Frame: Up to 52 weeks
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either definitely related, probably related, possibly related or unrelated.
Up to 52 weeks
Percentage of Participants With Composite Complete Remission Rate (CR + CRi)
Time Frame: Up to 52 weeks
Composite Complete remission (CRc) is defined as Complete Remission (CR) + CRi (CR with incomplete blood count recovery) based on protocol criteria.
Up to 52 weeks
Median Time to Best Response
Time Frame: Up to 52 weeks.
Time to Best Response is measured as the time in months from the first dose of study treatment to the date of first documented documentation of a confirmed response of partial response (PR) or better.
Up to 52 weeks.
Median Treatment Duration
Time Frame: Up to 52 weeks
Median time for duration of oral venetoclax treatment in participants with Acute Myeloid Leukemia.
Up to 52 weeks
Median Overall Survival
Time Frame: Up to 52 weeks
Time from the date of first oral Venetoclax intake to the date of death from any cause.
Up to 52 weeks
Median Duration of Composite Complete Remission
Time Frame: Up to 52 weeks
Time from the date of first oral Venetoclax intake and the date of the assessment having documented Complete Remission with incomplete Hematologic recovery (CRi).
Up to 52 weeks

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AbbVie

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: ABBVIE INC., AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 28, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 22, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 22, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 24, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 27, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 24, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • P20-408

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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