AzTrials
AzTrials

Acute Myeloid Leukemia (AML)NCT04813263

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

An observational study of Acute Myeloid Leukemia (AML), run by AbbVie at 281 sites in Japan.

Completed

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

Official record
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Trial summary

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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Acute Myeloid Leukemia (AML)
How many people
424 participants
Where
281 sitesJapan
Study dates
28 May 2021to 30 Apr 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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • None

Trial locations and contacts

281 sites in 1 country.

281 sites in 1 country

Japan281 sites

  • Ageo Central General Hospital /ID# 254515

    Ageo-shi, Saitama, 362-8588

  • Akita city Hospital /ID# 240008

    Akita, Akita, 010-0933

  • Ako Central Hospital /ID# 239721

    Ako-shi, Hyōgo, 678-0241

  • Hyogo Prefectural Amagasaki General Medical Center /ID# 239355

    Amagasaki-shi, Hyōgo, 660-8550

  • Anan Medical Center /ID# 243781

    Anan-shi, Tokushima, 774-0045

  • Anjou Kousei Hospital /ID# 244213

    Anjo-shi, Aichi-ken, 446-8602

  • Aomori Prefectural Central Hospital /ID# 249442

    Aomori, Aomori, 030-8553

  • Asahi General Hospital /ID# 233889

    Asahi-shi, Chiba, 289-2511

  • TMG Asaka Medical Center /ID# 238761

    Asaka-shi, Saitama, 351-0023

  • National Hospital Organization Beppu Medical Center /ID# 247894

    Beppu-shi, Oita Prefecture, 874-0011

  • Kyushu University Beppu Hospital /ID# 249444

    Beppu-shi, Oita Prefecture, 874-0838

  • Juntendo University Hospital /ID# 239096

    Bunkyo-ku, Tokyo, 113-8431

  • Tokyo Medical And Dental University Hospital /ID# 242178

    Bunkyo-ku, Tokyo, 113-8519

  • Chiba Aoba Municipal Hospital /ID# 240565

    Chiba, Chiba, 260-0852

  • Chiba University Hospital /ID# 246011

    Chiba, Chiba, 260-8677

  • Duplicate_Chiba Cancer Center /ID# 248122

    Chiba, Chiba, 260-8717

  • Inoue Memorial Hospital /ID# 239351

    Chiba, 260-0027

  • National Hospital Organization Chiba Medical Center /ID# 266755

    Chiba, 260-0042

  • Shonan Tobu Sogo Hospital /ID# 241913

    CHIGASAKI-shi, Kanagawa, 253-0083

  • St.Luke's International Hospital /ID# 248787

    Chuo-ku, Tokyo, 104-8560

  • University of Yamanashi Hospital /ID# 246006

    Chuo-shi, Yamanashi, 409-3821

  • Kita Fukushima Medical Center /ID# 250296

    Date-shi, Fukushima, 960-0502

  • Medical Plaza Edogawa /ID# 244220

    Edogawa Ward, Tokyo, 133-0052

  • Edogawa Hospital /ID# 239352

    Edogawa-ku, Tokyo, 133-0052

  • Tama Medical Center /ID# 247954

    Fuchū, Tokyo, 183-8524

  • Tokyo Metropolitan Children's Medical Center /ID# 252189

    Fuchū, Tokyo, 183-8524

  • Kamifukuoka General Hospital /ID# 247890

    Fujimino, Saitama, 356-0011

  • Fujioka General Hospital /ID# 255196

    Fujioka-shi, Gunma, 375-0015

  • Fujisawa City Hospital /ID# 239375

    Fujisawa-shi, 251-8550

  • Fukuiken Saiseikai Hospital /ID# 245062

    Fukui-shi, Fukui, 918-8503

  • Fukuiken Saiseikai Hospital /ID# 246005

    Fukui-shi, Fukui, 918-8503

  • Saiseikai Fukuoka Genaral Hospital /ID# 255193

    Fukuoka, Fukuoka, 810-0001

  • National Hospital Organization Kyushu Medical Center /ID# 242026

    Fukuoka, Fukuoka, 810-8563

  • Fukuoka Wajiro Hospital /ID# 238755

    Fukuoka, Fukuoka, 811-0213

  • National Hospital Organization Kyushu Cancer Center /ID# 244217

    Fukuoka, Fukuoka, 811-1395

  • Kyushu University Hospital /ID# 248781

    Fukuoka, Fukuoka, 812-8582

  • Fukuoka University Hospital /ID# 244214

    Fukuoka, Fukuoka, 814-0180

  • Japanese Red Cross Fukuoka Hospital /ID# 241181

    Fukuoka, Fukuoka, 815-8555

  • Murakami Karindoh Hospital /ID# 256179

    Fukuoka, Fukuoka, 819-0032

  • Harasanshin Hospital /ID# 240881

    Fukuoka, 812-0033

  • Fukushima Minami Cardiovascular Hospital /ID# 252216

    Fukushima, Fukushima, 960-8163

  • Fussa Hospital /ID# 240570

    Fussa, Tokyo, 1970012

  • Gifu Municipal Hospital /ID# 241156

    Gifu, Gifu, 500-8513

  • Gifu University Hospital /ID# 241183

    Gifu, Gifu, 501-1194

  • Gifu Red Cross Hospital /ID# 240562

    Gifu, Gifu, 502-8511

  • Nagasaki Goto Chuoh Hospital /ID# 239723

    Goto-shi, Nagasaki, 853-0031

  • Shiroyama Hospital /ID# 246762

    Habikino-shi, Osaka, 583-0872

  • Hachinohe Red Cross Hospital /ID# 250850

    Hachinohe-shi, 039-1104

  • Tokai University Hachioji Hospital /ID# 266804

    Hachiōji, 192-0032

  • National Hospital Organization Hamada Medical Center /ID# 250858

    Hamada, Shimane, 697-0022

  • National Hospital Organization Mito Medical Center /ID# 239719

    Higashi Ibaraki-gun, Ibaraki, 311-3193

  • Higashihiroshima Medical Center /ID# 250849

    Higashihiroshima-shi, 739-0041

  • Tama-Hokubu Medical Center /ID# 245879

    Higashimurayama-shi, Tokyo, 189-8511

  • Okitama Public General Hospital /ID# 242710

    Higashiokitama-gun, Yamagata, 992-0601

  • Ishikiriseiki Hospital /ID# 246077

    Higashiosaka, Osaka, 579-8026

  • Kansai Medical University Hospital /ID# 246820

    Hirakata-shi, Osaka, 573-1191

  • National Hospital Organization Hirosaki General Medical Center /ID# 246008

    Hirosaki-shi, Aomori, 036-8545

  • Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital /ID# 240880

    Hiroshima, Hiroshima, 730-8619

  • Hiroshima Prefecture Hospital /ID# 252215

    Hiroshima, 734-8530

  • Hitachi General Hospital /ID# 239376

    Hitachi-shi, Ibaraki, 317-0077

  • KK Clinic Ichihara /ID# 250859

    Ichihara, Chiba, 290-0035

  • Chiba Rosai Hospital /ID# 238767

    Ichihara-shi, Chiba, 290-0003

  • Tokyo Dental College Ichikawa General Hospital /ID# 262626

    Ichikawa-shi, Chiba, 272-0824

  • Aso Iizuka Hospital /ID# 266806

    Iizuka, Fukuoka, 820-8505

  • Ikeda City Hospital /ID# 266802

    Ikeda, 563-0025

  • Nara Hospital Kinki University Faculty of Medicine, /ID# 250295

    Ikoma-shi, Nara, 630-0227

  • Nippon Medical Chiba Hokusoh Hospital /ID# 250297

    Inzai-shi, Chiba, 270-1613

  • Itami City Hospital /ID# 233888

    Itami-shi, Hyōgo, 6640006

  • Tokiwakai Jyoban Hospital /ID# 257007

    Iwaki, Fukushima, 972-8322

  • Iwaki Kyoritsu General Hospital /ID# 260209

    Iwaki, Fukushima, 973-8555

  • NHO Iwakuni Clinical Center /ID# 242170

    Iwakuni-shi, Yamaguchi, 740-8510

  • Izumi City General Hospital /ID# 253204

    Izumi-shi, Osaka, 594-0073

  • Osaka Women's and Children's Hospital /ID# 266805

    Izumi-Shi, Osaka, 594-1101

  • Shimane University Hospital /ID# 255194

    Izumo-shi, Shimane, 693-8501

  • Shimane Prefectural Central Ho /ID# 247895

    Izumo-shi, Shimane, 693-8555

  • Imakiire General Hospital /ID# 258237

    Kagoshima, Kagoshima-ken, 890-0051

  • Imamura General Hospital /ID# 234006

    Kagoshima, Kagoshima-ken, 890-0064

  • Kainan Medical Center /ID# 240825

    Kainan, Wakayama, 642-0002

  • Shonan Kamakura General Hospital /ID# 243053

    Kamakura-shi, Kanagawa, 247-8533

  • Kameda General Hospital /ID# 241877

    Kamogawa-shi, Chiba, 296-8602

  • JCHO Kanazawa Hospital /ID# 239379

    Kanazawa, Ishikawa-ken, 920-0013

  • Medical Corporation Seijinkai Ikeda Hospital /ID# 242174

    Kanoya-shi, Kagoshima-ken, 893-0024

  • Nara Medical University Hospital /ID# 251726

    Kashihara-shi, Nara, 634-8522

  • The Jikei University Kashiwa Hospital /ID# 259510

    Kashiwa-shi, Chiba, 277-8567

  • National Cancer Center Hospital East /ID# 241917

    Kashiwa-shi, Chiba, 277-8577

  • Kawaguchi Municipal Medical Center /ID# 246080

    Kawaguchi-shi, 333-0833

  • Teikyo University Mizonokuchi Hospital /ID# 244842

    Kawasaki, Kanagawa, 213-8507

  • Kawasaki Municipal Hospital /ID# 241162

    Kawasaki-shi, Kanagawa, 2100013

  • Japan Organization of Occupational Health and Society Kanto Rosai Hospital /ID# 255195

    Kawasaki-shi, Kanagawa, 211-8510

  • Toranomon Hospital Kajigaya /ID# 256186

    Kawasaki-shi, Kanagawa, 213-8587

  • Naga municipal Hospital /ID# 250259

    Kinokawa, Wakayama, 649-6414

  • Kimitsu Chuo Hospital /ID# 248776

    Kisarazu-shi, Chiba, 292-8535

  • Kishiwada City Hospital /ID# 234002

    Kishiwada-shi, Osaka, 596-8501

  • Sumitomo Hospital /ID# 243774

    Kita-ku, Osaka, 530-0005

  • Meirikai Chuo General Hospital /ID# 238751

    Kita-ku, Tokyo, 114-0001

  • Kitakyusyu General Hospital /ID# 244212

    Kitakyushu-shi, 800-0257

  • NHO Kokura Medical Center /ID# 257008

    Kitakyusyu-shi, Fukuoka, 802-8533

  • Wakamatsu Hospital /ID# 251728

    Kitakyusyu-shi, Fukuoka, 808-0024

  • Kitami Red Cross Hospital /ID# 251065

    Kitami-shi, Hokkaido, 090-0026

  • Hyogo Prefectural Kobe Children's Hospital /ID# 245817

    Kobe, Hyōgo, 650-0047

  • Kobe City Medical Center General Hospital /ID# 246010

    Kobe, Hyōgo, 650-0047

  • Shinko Hospital /ID# 233782

    Kobe, Hyōgo, 651-0072

  • Konan Medical Center /ID# 246079

    Kobe, Hyōgo, 658-0064

  • Kochi Health Sciences Center /ID# 241182

    Kochi, Kochi, 781-0111

  • Showa General Hospital /ID# 258235

    Kodaira, Tokyo, 187-8510

  • Ohta Nishinouchi Hospital /ID# 243052

    Koriyama-shi, Fukushima, 963-8558

  • Duplicate_The Cancer Institute Hospital Of JFCR /ID# 244216

    Koto-ku, Tokyo, 135-8550

  • Shinkuki General Hospital /ID# 254516

    Kuki-shi, Saitama, 346-0021

  • National Hospital Organization Kumamoto Medical Center /ID# 240886

    Kumamoto, Kumamoto, 860-0008

  • Kumamoto University Hospital /ID# 239720

    Kumamoto, Kumamoto, 8608556

  • Kumamoto Shinto General Hospital /ID# 242176

    Kumamoto, Kumamoto, 862-8655

  • Kumamoto City Hospital /ID# 254494

    Kumamoto-shi,Kumamoto, Kumamoto, 862-8505

  • Kawasaki Medical School Hospital /ID# 242709

    Kurashiki-shi, Okayama-ken, 701-0192

  • Kurashiki Central Hospital /ID# 244205

    Kurashiki-shi, Okayama-ken, 710-8602

  • Kurobe City Hospital /ID# 254493

    Kurobe-shi, Toyama, 938-8502

  • Shinkoga Hospital /ID# 248786

    Kurume, Fukuoka, 830-0033

  • Kurume University Hospital /ID# 240885

    Kurume-shi, Fukuoka, 830-0011

  • St. Mary's Hospital /ID# 242332

    Kurume-shi, Fukuoka, 830-8543

  • Omi Medical Center /ID# 258233

    Kusatsu-shi, Shiga, 525-0066

  • University Hospital Kyoto Prefectural University of Medicine /ID# 244843

    Kyoto, Kyoto, 602-8566

  • JCHO Kyoto Kuramaguchi Medical /ID# 248775

    Kyoto, Kyoto, 603-8151

  • Japanese Red Cross Kyoto Daiichi Hosital /ID# 248124

    Kyoto, Kyoto, 605-0981

  • Kyoto University Hospital /ID# 244844

    Kyoto, Kyoto, 606-8507

  • National Hospital Organization Kyoto Medical Center /ID# 239092

    Kyoto, Kyoto, 612-8555

  • Gunmaken Saiseikai Maebashi Hospital /ID# 239383

    Maebashi, Gunma, 371-0821

  • Kaneda Hospital /ID# 238757

    Maniwa, Okayama-ken, 719-3105

  • Masuda Red Cross Hospital /ID# 248780

    Masuda-shi, Shimane, 698-0003

  • Chiba West General Hospital /ID# 262918

    Matsudo-shi, Chiba, 270-2251

  • Watanabe Hospital /ID# 254476

    Matsuyama, Ehime, 108-0073

  • Ehime Prefectural Central Hospital /ID# 261348

    Matsuyama, Ehime, 790-0024

  • Matsuyama Shimin Hospital /ID# 243050

    Matsuyama, Ehime, 790-0067

  • National Hospital Organization Shikoku Cancer Center /ID# 242171

    Matsuyama, Ehime, 791-0280

  • Mishuku Hospital /ID# 239378

    Meguro-ku, Tokyo, 153-0051

  • Kosei Chuo General Hospital /ID# 251011

    Meguro-ku, Tokyo, 1538581

  • Mihara Shiromachi Hospital /ID# 246754

    Mihara, Hiroshima, 723-0014

  • Toranomon Hospital /ID# 251010

    Minato-ku, Tokyo, 105-8470

  • Kyorin University - Mitaka Campus /ID# 243777

    Mitaka, 181-8611

  • Miyazaki Prefectural Miyazaki Hospital /ID# 251730

    Miyazaki, Miyazaki, 880-8510

  • Koga General Hospital /ID# 248120

    Miyazaki, Miyazaki, 8800041

  • University of Miyazaki Hospital /ID# 248805

    Miyazaki, Miyazaki, 889-1692

  • Steel Memorial Muroran Hospita /ID# 231383

    Muroran-shi, Hokkaido, 050-0076

  • Japanese Red Cross Musashino Hospital /ID# 246765

    Musashino-shi, Tokyo, 180-8610

  • Miyazaki Prefectural Nobeoka Hospital /ID# 248715

    Nabeoka-shi, Miyazaki, 882-0835

  • Jap Red Cross Nagasaki Genbaku /ID# 245029

    Nagasaki, Nagasaki, 852-8104

  • Nagasaki University Hospital /ID# 245028

    Nagasaki, Nagasaki, 852-8501

  • Nagoya City West Medical Center /ID# 250844

    Nagoya, Aichi-ken, 462-8508

  • Aichi Cancer Center Hospital /ID# 243785

    Nagoya, Aichi-ken, 464-8681

  • Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital /ID# 242173

    Nagoya, Aichi-ken, 466-8650

  • Nagoya University Hospital /ID# 246009

    Nagoya, Aichi-ken, 4668560

  • Nagoya City University Hospital /ID# 256177

    Nagoya, Aichi-ken, 467-8602

  • Naha City Hospital /ID# 242027

    Naha, Okinawa, 902-0061

  • University of the Ryukyus Hospital /ID# 246821

    Nakagami-gun, Okinawa, 903-0215

  • Nara Prefecture General Medical Center /ID# 254492

    Nara, Nara, 630-8054

  • Tsudanuma Central General Hospital /ID# 245890

    Narashino-shi, Chiba, 275-0026

  • Japanese Red Cross Narita Hospital /ID# 243775

    Narita-shi, Chiba, 286-8523

  • IUHW Narita Hospital /ID# 240574

    Narita-shi, Chiba, 2868520

  • Chibaken Saiseikai Narashino Hospital /ID# 254491

    Narshino-shi, Chiba, 275-8580

  • Tokushima Prefecture Naruto Hospital /ID# 239095

    Naruto-shi, Tokushima, 772-0001

  • Miyagi Cancer Center /ID# 241879

    Natori-shi, Miyagi, 981-1293

  • Juntendo Univ Nerima Hospital /ID# 250292

    Nerima-ku, Tokyo, 177-0033

  • Seijukai Hospital /ID# 248788

    Neyagawa, Osaka, 572-0022

  • Niigata University Medical & Dental Hospital /ID# 245027

    Niigata, Niigata, 951-8520

  • Hyogo?Prefectural?Nishinomiya Hospital /ID# 239354

    Nishinomiya-shi, Hyōgo, 662-0918

  • Hyogo Medical University Hospital /ID# 240569

    Nishinomiya-shi, Hyōgo, 663-8501

  • Obihiro kosei Hospital /ID# 252218

    Obihiro-shi, Hokkaido, 080-0024

  • National Center for Geriatrics and Gerontology /ID# 251683

    Obu-shi, Aichi-ken, 474-8511

  • Odate Municipal General Hospital /ID# 258238

    Odate-shi, Akita, 017-0885

  • Ogaki Municipal Hospital /ID# 239353

    Ogaki-shi, Gifu, 503-8502

  • Oita Memorial Hospital /ID# 246818

    Ōita, Oita Prefecture, 870-0854

  • Oita Prefectural Hospital /ID# 243786

    Ōita, Oita Prefecture, 870-0855

  • Almeida Memorial Hospital /ID# 241916

    Ōita, Oita Prefecture, 870-1133

  • Duplicate_Okayama University Hospital /ID# 240887

    Okayama, Okayama-ken, 700-8558

  • Duplicate_Okayama University Hospital /ID# 243755

    Okayama, Okayama-ken, 700-8558

  • Japanese Red Cross Okayama Hospital /ID# 240879

    Okayama, Okayama-ken, 700-8607

  • Okayama Medical Center /ID# 243759

    Okayama, Okayama-ken, 701-1192

  • Nakagami Hospital /ID# 243787

    Okinawa-shi, Okinawa, 904-2195

  • P_Ome Municipal General Hospital /ID# 248778

    Ōme, Tokyo, 198-0042

  • NHO Nagasaki Medical Center /ID# 240571

    Omura-shi, Nagasaki, 856-8562

  • Omuta City Hospital /ID# 246823

    Omuta-shi, Fukuoka, 836-0861

  • Kita-harima Medical Center /ID# 254490

    Ono-shi, Hyōgo, 675-1327

  • Osaka Saiseikai Nakatsu Hospital /ID# 244209

    Osaka, Osaka, 530-0012

  • Kitano Hospital /ID# 248785

    Osaka, Osaka, 530-8480

  • Osaka City General Hospital /ID# 244210

    Osaka, Osaka, 534-0021

  • National Hospital Organization Osaka National Hospital /ID# 238764

    Osaka, Osaka, 540-0006

  • Otemae Hospital /ID# 250857

    Osaka, Osaka, 540-0008

  • Osaka International Cancer Institute /ID# 248783

    Osaka, Osaka, 541-8567

  • Japanese Red Cross Osaka Hospi /ID# 248784

    Osaka, Osaka, 543-8555

  • Daini Osaka Police Hospital /ID# 240560

    Osaka, Osaka, 543-8922

  • Osaka Metropolitan University Hospital /ID# 253203

    Osaka, Osaka, 545-8586

  • Nippon Life Saiseikai Public Interest Foundation Nippon Life Hospital /ID# 243783

    Osaka, Osaka, 550-0006

  • Kindai University Hospital /ID# 250851

    Osakasayama-shi, Osaka, 589-8511

  • Osaki Citizen Hospital /ID# 249447

    Osaki-shi, Miyagi, 989-6183

  • Iwate Prefectural Isawa Hospital /ID# 246819

    Oshu-shi, Iwate, 0230864

  • Gunma Prefectural Cancer Center /ID# 242177

    Ota-shi, Gunma, 373-8550

  • NHO Hiroshima-Nishi Medical center /ID# 238766

    Otake-shi, Hiroshima, 739-0696

  • Saiseikai Shiga Hospital /ID# 239381

    Rittō, Shiga, 520-3046

  • Saga Medical Center Koseikan /ID# 245816

    Saga, Saga-ken, 840-8571

  • Nankai Medical Center /ID# 241914

    Saiki-shi, 876-0857

  • Saitama City Hospital /ID# 240567

    Saitama, 336-8522

  • Saitama Citizens Medical Center /ID# 252573

    Saitama-shi, Saitama, 331-0054

  • Sakaide City Hospital /ID# 240563

    Sakaidechō, Kagawa-ken, 7620043

  • Nihonkai General Hospital /ID# 242024

    Sakata-shi, 998-0828

  • Toho University Sakura Medical Center /ID# 252187

    Sakura-shi, Chiba, 285-8741

  • Sapporo Hokuyu Hospital /ID# 250856

    Sapporo, Hokkaido, 003-0006

  • Homecareclinicn-Consept /Id# 239377

    Sapporo, Hokkaido, 003-0803

  • Hokkaido Cancer Center /ID# 249441

    Sapporo, Hokkaido, 003-0804

  • Sapporo Hokushin Hospital /ID# 241878

    Sapporo, Hokkaido, 004-0052

  • Sapporo Kiyota Hospital /ID# 231385

    Sapporo, Hokkaido, 004-0831

  • Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 249446

    Sapporo, Hokkaido, 060-0033

  • Sapporo Medical University Hospital /ID# 252217

    Sapporo, Hokkaido, 060-8543

  • Hokkaido University Hospital /ID# 244223

    Sapporo, Hokkaido, 060-8648

  • Aiiku Hospital /ID# 239047

    Sapporo, Hokkaido, 064-0804

  • Tenshi Hospital /ID# 243051

    Sapporo, Hokkaido, 065-0012

  • Sasebo City General Hospital /ID# 238759

    Sasebo-shi, Nagasaki, 857-0056

  • Miyagi Chuo Hospital /ID# 259511

    Sendai, Miyagi, 980-0011

  • Tohoku University Hospital /ID# 243757

    Sendai, Miyagi, 9808574

  • National Hospital Organization Sendai Medical Center /ID# 239384

    Sendai, Miyagi, 983-8520

  • Metropolitan Research and Treatment Center for Blood Disorders /ID# 231384

    Setagaya Ward, Tokyo, 156-0052

  • National Center for Child Health and Development /ID# 243778

    Setagaya-ku, Tokyo, 157-8535

  • National Hospital Organization Shibukawa Medical Center /ID# 245026

    Shibukawa-shi, Gunma, 377-0280

  • Japanese Red Cross Medical Center /ID# 239385

    Shibuya-ku, Tokyo, 150-8935

  • Duplicate_Dokkyo Medical University Hospital /ID# 246764

    Shimotsuga-gun, Tochigi, 321-0293

  • Ishibashi General Hospital /ID# 243762

    Shimotsuke, Tochigi, 329-0502

  • NTT Medical Center Tokyo /ID# 240566

    Shinagawa-ku, Tokyo, 141-8625

  • Tokyo Medical University Hospital /ID# 252571

    Shinjuku-ku, Tokyo, 160-0023

  • Center hospital of the National Center for Global Health and Medicine /ID# 256189

    Shinjuku-ku, Tokyo, 162-8655

  • Shirakawa Kosei General Hosp. /ID# 245815

    Shirakawa-shi, Fukushima, 961-0005

  • Iwate Medical University Hospital /ID# 251009

    Shiwa-gun, Iwate, 028-3695

  • Shizuoka Saiseikai Genaral Hospital /ID# 239722

    Shizuoka, Shizuoka, 422-8527

  • Tokuyama Central Hospital /ID# 242380

    Shunan-shi, Yamaguchi, 745-8522

  • Kawakita General Hospital /ID# 257009

    Suginami-ku, Tokyo, 166-8588

  • Tokyo Metropolitan Bokutoh Hospital /ID# 241912

    Sumida-ku, Tokyo, 130-8575

  • The Fraternity Memorial Hospital /ID# 251685

    Sumida-ku, Tokyo, 1308587

  • Sunagawa City Medical Center /ID# 239382

    Sunagawa, Hokkaido, 073-0164

  • Tokyo Metropolitan Geriatric /ID# 249448

    tabashi City, Tokyo, 173-0015

  • Duplicate_Teikyo University Hospital /ID# 247896

    tabashi City, Tokyo, 173-8606

  • Tachikawa Hospital /ID# 245878

    Tachikawa

  • Eiju General Hospital /ID# 243763

    Taitō City, Tokyo, 110-0015

  • Takatsuki Red Cross Hospital /ID# 266756

    Takatsuki, 569-1045

  • Osaka Medical and Pharmaceutical University Hospital /ID# 249440

    Takatsuki-shi, Osaka, 569-8686

  • Japanese Red Cross Takayama Hospital /ID# 240568

    Takayama, Gifu, 506-0025

  • Kumamoto Kenhoku Hospital /ID# 258240

    Tamana-shi, Kumamoto, 865-0005

  • Hyogo Prefectural Tamba Medical Center /ID# 240884

    Tamba-shi, Hyōgo, 669-3464

  • Social Insurance Kinan Hosp /ID# 251684

    Tanabe-shi, Wakayama, 646-0011

  • Hyogo College of Medicine Sasayama Medical Center /ID# 240888

    Tanbasasayama-shi, Hyōgo, 669-2321

  • Tatebayashi Kosei General Hospital /ID# 252188

    Tatebayashi-shi, Gunma, 374-0055

  • Tenri Hospital /ID# 250855

    Tenri-shi, Nara, 632-8552

  • Tokushima University Hospital /ID# 252572

    Tokushima, Tokushima, 770-8503

  • Toshiba General Hospital /ID# 250294

    Tokyo, 140-8522

  • Ehime University Hospital /ID# 244207

    Toon-shi, Ehime, 791-0295

  • JA Toride Medical Center /ID# 240573

    Toride-shi, Ibaraki, 302-0022

  • Tottori Prefectural Central Ho /ID# 245877

    Tottori-shi, Tottori, 680-0901

  • Toyama Hospital /ID# 243779

    Toyama, 939-8511

  • Toyohashi Municipal Hospital /ID# 243784

    Toyohashi, Aichi-ken, 441-8570

  • Toyokawa City Hospital /ID# 242707

    Toyokawa-shi, Aichi-ken, 442-8561

  • Toyota Memorial Hospital /ID# 242175

    Toyota-shi, Aichi-ken, 471-8513

  • Takeuchi Hospital /ID# 238750

    Tsu, Mie-ken, 514-0031

  • University of Tsukuba Hospital /ID# 242023

    Tsukuba, Ibaraki, 305-8576

  • Yamaguchi University Hospital /ID# 245060

    Ube-shi, Yamaguchi, 755-8505

  • Uji Tokushukai Medical Center /ID# 241876

    Uji-shi, Kyoto, 611-0042

  • Kumamoto Minami National Hospital /ID# 242169

    Uki, Kumamoto, 869-0524

  • Tochigi Cancer Center /ID# 249445

    Utsunomiya, Tochigi, 320-0834

  • Wakayama Rosai Hospital /ID# 250293

    Wakayama, Wakayama, 640-8505

  • Wakkanai City Hospital /ID# 243782

    Wakkanai, Hokkaido, 097-0022

  • NHO Saitama National Hospital /ID# 245061

    Wako-shi, Saitama, 351-0102

  • Yamagata University Hospital /ID# 246763

    Yamagata, Yamagata, 990-9585

  • Shonai Hospital /ID# 254514

    Yamagata, 9978515

  • Ogori Daiichi General Hospital /ID# 246761

    Yamaguchi, Yamaguchi, 754-0002

  • Nagata Hospital /ID# 256180

    Yanagawa-shi, Fukuoka, 832-0059

  • Yao Tokushukai General Hospital /ID# 247884

    Yao, Osaka, 581-0011

  • JCHO Kumamoto General Hospital /ID# 248779

    Yatsushiro, Kumamoto, 866-0856

  • Yokohama City University Medical Center /ID# 248777

    Yokohama, Kanagawa, 232-0024

  • Saiseikai Yokohamashi Nanbu Hospital /ID# 247955

    Yokohama, Kanagawa, 234-8503

  • St. Marianna University School of Medicine Yokohama City Seibu Hospital /ID# 266803

    Yokohama, Kanagawa, 241-0811

  • Kanagawa Cancer Center /ID# 246822

    Yokohama, Kanagawa, 241-8515

  • Yonago Medical Center /ID# 240572

    Yonago-shi, Tottori, 683-0006

  • Tottori University Hospital /ID# 244215

    Yonago-shi, Tottori, 683-8504

  • Oita University Hospital /ID# 261976

    Yufu, Oita Prefecture, 879-5503

  • Toshima Hospital /ID# 240878

    板橋区, Tokyo, 173-0015

  • Hara Hospital /ID# 244846

    泉大津市, Osaka, 595-0006

  • Hyogo Prefectural Awaji Medical Center /ID# 240823

    洲本市, Hyōgo, 656-0021

Other trials in Japan

About this study

Official title: 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.

Read more

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.

Keywords
Acute Myeloid Leukemia (AML), Cancer, Venetoclax, Venclexta, Venclyxto
Medical subject headings
Leukemia, Myeloid, Acute, Neoplasms

What participants receive

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

Study groups in NCT04813263
Study groupRoleWhat they receive
Participants Treated With VenetoclaxParticipants who are administrated venetoclax for treatment of AML under routine clinical practice.

What is being measured

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

  1. Percentage of Participants With ≥ Grade 3 Neutropenia of Venetoclax Regimens With Unfit Acute Myeloid Leukemia (AML)

    Percentage of participants with a high grade (≥ Grade 3) protocol specified neutropenia during and after treatment with venetoclax.

    Measured: Up to 52 weeks.

Secondary outcomes (10)

  1. Percentage of Participants With Febrile Neutropenia and Thrombocytopenia

    Percentage of participants with protocol specified febrile neutropenia and thrombocytopenia during and after treatment with venetoclax.

    Measured: Up to 52 weeks

  2. Percentage of Participants With Tumor Lysis Syndrome (TLS)

    Percentage of participants with protocol specified TLS during and after treatment with venetoclax.

    Measured: Up to 52 weeks

  3. Percentage of Participants Reported >= Grade 3 Adverse Events (AE)/Adverse Drug Reactions (ADR)

    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.

    Measured: Up to 52 weeks

  4. Percentage of Participants Reported Adverse Events (AE)/Adverse Drug Reaction (ADR)

    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.

    Measured: Up to 52 weeks

  5. Percentage of Participants With AE/ADR When Used Concomitantly With CYP3A Inhibitors or Growth Colony Stimulating Factor (G-CSF)

    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.

    Measured: Up to 52 weeks

  6. Percentage of Participants With Composite Complete Remission Rate (CR + CRi)

    Composite Complete remission (CRc) is defined as Complete Remission (CR) + CRi (CR with incomplete blood count recovery) based on protocol criteria.

    Measured: Up to 52 weeks

  7. Median Time to Best Response

    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.

    Measured: Up to 52 weeks.

  8. Median Treatment Duration

    Median time for duration of oral venetoclax treatment in participants with Acute Myeloid Leukemia.

    Measured: Up to 52 weeks

  9. Median Overall Survival

    Time from the date of first oral Venetoclax intake to the date of death from any cause.

    Measured: Up to 52 weeks

  10. Median Duration of Composite Complete Remission

    Time from the date of first oral Venetoclax intake and the date of the assessment having documented Complete Remission with incomplete Hematologic recovery (CRi).

    Measured: Up to 52 weeks

Timeline

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

  1. First posted24 Mar 2021
  2. Study start28 May 2021
  3. Primary completion30 Apr 2024
  4. Study completion30 Apr 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
424 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04813263
Sponsor's protocol ID
P20-408
Status last verified
Apr 2025
First submitted
22 Mar 2021
Last updated
27 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Myeloid Leukemia (AML), run by AbbVie at 281 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 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 281 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?

Percentage of Participants With ≥ Grade 3 Neutropenia of Venetoclax Regimens With Unfit Acute Myeloid Leukemia (AML) (time frame: Up to 52 weeks.). 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 NCT04813263.

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 Apr 2025.

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