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

Acute Myeloid Leukemia (AML) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04813263
• Other study ID #: P20-408
• Status: Completed
• Start date: May 28, 2021
• Est. completion date: April 30, 2024

Study information

• Verified date: May 2024
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 424
• Est. completion date: April 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

None

Related Conditions & MeSH terms

• Acute Myeloid Leukemia (AML)
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Locations

Country	Name	City	State
Japan	Takeuchi Hospital /ID# 238750	??	Mie
Japan	Hyogo Prefectural Awaji Medical Center /ID# 240823	???	Hyogo
Japan	Japanese Red Cross Takayama Hospital /ID# 240568	???	Gifu
Japan	Kainan Medical Center /ID# 240825	???	Wakayama
Japan	Kochi Health Sciences Center /ID# 241182	???	Kochi
Japan	Sapporo Kiyota Hospital /ID# 231385	???	Hokkaido
Japan	Toshima Hospital /ID# 240878	???	Tokyo
Japan	Hara Hospital /ID# 244846	????	Osaka
Japan	Ishikiriseiki Hospital /ID# 246077	????	Osaka
Japan	Ageo Central General Hospital /ID# 254515	Ageo-shi	Saitama
Japan	Akita city Hospital /ID# 240008	Akita-shi	Akita
Japan	Ako Central Hospital /ID# 239721	Ako-shi	Hyogo
Japan	Hyogo Prefectural Amagasaki General Medical Center /ID# 239355	Amagasaki-shi	Hyogo
Japan	Anan Medical Center /ID# 243781	Anan-shi	Tokushima
Japan	Anjou Kousei Hospital /ID# 244213	Anjo-shi	Aichi
Japan	Aomori Prefectural Central Hospital /ID# 249442	Aomori-shi	Aomori
Japan	Asahi General Hospital /ID# 233889	Asahi-shi	Chiba
Japan	TMG Asaka Medical Center /ID# 238761	Asaka-shi	Saitama
Japan	Meirikai Chuo General Hospital /ID# 238751	Bei Qu	Tokyo
Japan	Kyushu University Beppu Hospital /ID# 249444	Beppu-shi	Oita
Japan	National Hospital Organization Beppu Medical Center /ID# 247894	Beppu-shi	Oita
Japan	Juntendo University Hospital /ID# 239096	Bunkyo-ku	Tokyo
Japan	Tokyo Medical And Dental University Hospital /ID# 242178	Bunkyo-ku	Tokyo
Japan	Inoue Memorial Hospital /ID# 239351	Chiba
Japan	National Hospital Organization Chiba Medical Center /ID# 266755	Chiba
Japan	Chiba Aoba Municipal Hospital /ID# 240565	Chiba-shi	Chiba
Japan	Chiba University Hospital /ID# 246011	Chiba-shi	Chiba
Japan	Duplicate_Chiba Cancer Center /ID# 248122	Chiba-shi	Chiba
Japan	Shonan Tobu Sogo Hospital /ID# 241913	CHIGASAKI-shi	Kanagawa
Japan	St.Luke's International Hospital /ID# 248787	Chuo-ku	Tokyo
Japan	University of Yamanashi Hospital /ID# 246006	Chuo-shi	Yamanashi
Japan	Kita Fukushima Medical Center /ID# 250296	Date-shi	Fukushima
Japan	Medical Plaza Edogawa /ID# 244220	Edogawa Ward	Tokyo
Japan	Edogawa Hospital /ID# 239352	Edogawa-ku	Tokyo
Japan	Tama Medical Center /ID# 247954	Fuchu	Tokyo
Japan	Tokyo Metropolitan Children's Medical Center /ID# 252189	Fuchu City	Tokyo
Japan	Kamifukuoka General Hospital /ID# 247890	Fujimino City	Saitama
Japan	Fujioka General Hospital /ID# 255196	Fujioka-shi	Gunma
Japan	Fujisawa City Hospital /ID# 239375	Fujisawa-shi
Japan	Fukuiken Saiseikai Hospital /ID# 245062	Fukui-shi	Fukui
Japan	Fukuiken Saiseikai Hospital /ID# 246005	Fukui-shi	Fukui
Japan	National Hospital Organization Kyushu Medical Center /ID# 242026	Fukuoka shi	Fukuoka
Japan	Fukuoka University Hospital /ID# 244214	Fukuoka-shi	Fukuoka
Japan	Fukuoka Wajiro Hospital /ID# 238755	Fukuoka-shi	Fukuoka
Japan	Harasanshin Hospital /ID# 240881	Fukuoka-shi
Japan	Japanese Red Cross Fukuoka Hospital /ID# 241181	Fukuoka-shi	Fukuoka
Japan	Kyushu University Hospital /ID# 248781	Fukuoka-shi	Fukuoka
Japan	Murakami Karindoh Hospital /ID# 256179	Fukuoka-shi	Fukuoka
Japan	National Hospital Organization Kyushu Cancer Center /ID# 244217	Fukuoka-shi	Fukuoka
Japan	Saiseikai Fukuoka Genaral Hospital /ID# 255193	Fukuoka-shi	Fukuoka
Japan	Fukushima Minami Cardiovascular Hospital /ID# 252216	Fukushima-shi	Fukushima
Japan	Fussa Hospital /ID# 240570	Fussa	Tokyo
Japan	Gifu Municipal Hospital /ID# 241156	Gifu-shi	Gifu
Japan	Gifu Red Cross Hospital /ID# 240562	Gifu-shi	Gifu
Japan	Gifu University Hospital /ID# 241183	Gifu-shi	Gifu
Japan	Nagasaki Goto Chuoh Hospital /ID# 239723	Goto-shi	Nagasaki
Japan	Shiroyama Hospital /ID# 246762	Habikino-shi	Osaka
Japan	Hachinohe Red Cross Hospital /ID# 250850	Hachinohe-shi
Japan	Tokai University Hachioji Hospital /ID# 266804	Hachioji
Japan	National Hospital Organization Hamada Medical Center /ID# 250858	Hamada City	Shimane
Japan	National Hospital Organization Mito Medical Center /ID# 239719	Higashi Ibaraki-gun	Ibaraki
Japan	Higashihiroshima Medical Center /ID# 250849	Higashihiroshima-shi
Japan	Tama-Hokubu Medical Center /ID# 245879	Higashimurayama-shi	Tokyo
Japan	Okitama Public General Hospital /ID# 242710	Higashiokitama-gun	Yamagata
Japan	Kansai Medical University Hospital /ID# 246820	Hirakata-shi	Osaka
Japan	National Hospital Organization Hirosaki General Medical Center /ID# 246008	Hirosaki-shi	Aomori
Japan	Hiroshima Prefecture Hospital /ID# 252215	Hiroshima
Japan	Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital /ID# 240880	Hiroshima-shi	Hiroshima
Japan	Hitachi General Hospital /ID# 239376	Hitachi-shi	Ibaraki
Japan	KK Clinic Ichihara /ID# 250859	Ichihara City	Chiba
Japan	Chiba Rosai Hospital /ID# 238767	Ichihara-shi	Chiba
Japan	Tokyo Dental College Ichikawa General Hospital /ID# 262626	Ichikawa-shi	Chiba
Japan	Aso Iizuka Hospital /ID# 266806	Iizuka	Fukuoka
Japan	Ikeda City Hospital /ID# 266802	Ikeda
Japan	Nara Hospital Kinki University Faculty of Medicine, /ID# 250295	Ikoma-shi	Nara
Japan	Nippon Medical Chiba Hokusoh Hospital /ID# 250297	Inzai-shi	Chiba
Japan	Duplicate_Teikyo University Hospital /ID# 247896	Itabashi-ku	Tokyo
Japan	Tokyo Metropolitan Geriatric /ID# 249448	Itabashi-ku	Tokyo
Japan	Itami City Hospital /ID# 233888	Itami-shi	Hyogo
Japan	Iwaki Kyoritsu General Hospital /ID# 260209	Iwaki-shi	Fukushima
Japan	Tokiwakai Jyoban Hospital /ID# 257007	Iwaki-shi	Fukushima
Japan	NHO Iwakuni Clinical Center /ID# 242170	Iwakuni-shi	Yamaguchi
Japan	Izumi City General Hospital /ID# 253204	Izumi-shi	Osaka
Japan	Osaka Women's and Children's Hospital /ID# 266805	Izumi-Shi	Osaka
Japan	Shimane Prefectural Central Ho /ID# 247895	Izumo-shi	Shimane
Japan	Shimane University Hospital /ID# 255194	Izumo-shi	Shimane
Japan	Imakiire General Hospital /ID# 258237	Kagoshima-shi	Kagoshima
Japan	Imamura General Hospital /ID# 234006	Kagoshima-shi	Kagoshima
Japan	Shonan Kamakura General Hospital /ID# 243053	Kamakura-shi	Kanagawa
Japan	Kameda General Hospital /ID# 241877	Kamogawa-shi	Chiba
Japan	JCHO Kanazawa Hospital /ID# 239379	Kanazawa-Shi	Ishikawa
Japan	Medical Corporation Seijinkai Ikeda Hospital /ID# 242174	Kanoya-shi	Kagoshima
Japan	Nara Medical University Hospital /ID# 251726	Kashihara-shi	Nara
Japan	National Cancer Center Hospital East /ID# 241917	Kashiwa-shi	Chiba
Japan	The Jikei University Kashiwa Hospital /ID# 259510	Kashiwa-shi	Chiba
Japan	Kawaguchi Municipal Medical Center /ID# 246080	Kawaguchi-shi
Japan	Teikyo University Mizonokuchi Hospital /ID# 244842	Kawasaki	Kanagawa
Japan	Japan Organization of Occupational Health and Society Kanto Rosai Hospital /ID# 255195	Kawasaki-shi	Kanagawa
Japan	Kawasaki Municipal Hospital /ID# 241162	Kawasaki-shi	Kanagawa
Japan	Toranomon Hospital Kajigaya /ID# 256186	Kawasaki-shi	Kanagawa
Japan	Naga municipal Hospital /ID# 250259	Kinokawa City	Wakayama
Japan	Kimitsu Chuo Hospital /ID# 248776	Kisarazu-shi	Chiba
Japan	Kishiwada City Hospital /ID# 234002	Kishiwada-shi	Osaka
Japan	Sumitomo Hospital /ID# 243774	Kita-ku	Osaka
Japan	Kitakyusyu General Hospital /ID# 244212	Kitakyushu-shi
Japan	NHO Kokura Medical Center /ID# 257008	Kitakyusyu-shi	Fukuoka
Japan	Wakamatsu Hospital /ID# 251728	Kitakyusyu-shi	Fukuoka
Japan	Kitami Red Cross Hospital /ID# 251065	Kitami-shi	Hokkaido
Japan	Hyogo Prefectural Kobe Children's Hospital /ID# 245817	Kobe-shi	Hyogo
Japan	Kobe City Medical Center General Hospital /ID# 246010	Kobe-shi	Hyogo
Japan	Konan Medical Center /ID# 246079	Kobe-shi	Hyogo
Japan	Shinko Hospital /ID# 233782	Kobe-shi	Hyogo
Japan	Showa General Hospital /ID# 258235	Kodaira	Tokyo
Japan	Ohta Nishinouchi Hospital /ID# 243052	Koriyama-shi	Fukushima
Japan	Duplicate_The Cancer Institute Hospital Of JFCR /ID# 244216	Koto-ku	Tokyo
Japan	Shinkuki General Hospital /ID# 254516	Kuki-shi	Saitama
Japan	Kumamoto University Hospital /ID# 239720	Kumamoto shi	Kumamoto
Japan	Kumamoto Shinto General Hospital /ID# 242176	Kumamoto-shi	Kumamoto
Japan	National Hospital Organization Kumamoto Medical Center /ID# 240886	Kumamoto-shi	Kumamoto
Japan	Kumamoto City Hospital /ID# 254494	Kumamoto-shi,Kumamoto	Kumamoto
Japan	Kawasaki Medical School Hospital /ID# 242709	Kurashiki-shi	Okayama
Japan	Kurashiki Central Hospital /ID# 244205	Kurashiki-shi	Okayama
Japan	Kurobe City Hospital /ID# 254493	Kurobe-shi	Toyama
Japan	Shinkoga Hospital /ID# 248786	Kurume City	Fukuoka
Japan	Kurume University Hospital /ID# 240885	Kurume-shi	Fukuoka
Japan	St. Mary's Hospital /ID# 242332	Kurume-shi	Fukuoka
Japan	Omi Medical Center /ID# 258233	Kusatsu-shi	Shiga
Japan	Japanese Red Cross Kyoto Daiichi Hosital /ID# 248124	Kyoto-shi	Kyoto
Japan	JCHO Kyoto Kuramaguchi Medical /ID# 248775	Kyoto-shi	Kyoto
Japan	Kyoto University Hospital /ID# 244844	Kyoto-shi	Kyoto
Japan	National Hospital Organization Kyoto Medical Center /ID# 239092	Kyoto-shi	Kyoto
Japan	University Hospital Kyoto Prefectural University of Medicine /ID# 244843	Kyoto-shi	Kyoto
Japan	Gunmaken Saiseikai Maebashi Hospital /ID# 239383	Maebashi-shi	Gunma
Japan	Kaneda Hospital /ID# 238757	Maniwa	Okayama
Japan	Masuda Red Cross Hospital /ID# 248780	Masuda-shi	Shimane
Japan	Chiba West General Hospital /ID# 262918	Matsudo-shi	Chiba
Japan	Watanabe Hospital /ID# 254476	Matsuyama City	Ehime
Japan	Ehime Prefectural Central Hospital /ID# 261348	Matsuyama-shi	Ehime
Japan	Matsuyama Shimin Hospital /ID# 243050	Matsuyama-shi	Ehime
Japan	National Hospital Organization Shikoku Cancer Center /ID# 242171	Matsuyama-shi	Ehime
Japan	Kosei Chuo General Hospital /ID# 251011	Meguro-ku	Tokyo
Japan	Mishuku Hospital /ID# 239378	Meguro-ku	Tokyo
Japan	Mihara Shiromachi Hospital /ID# 246754	Mihara	Hiroshima
Japan	Toranomon Hospital /ID# 251010	Minato-ku	Tokyo
Japan	Kyorin University - Mitaka Campus /ID# 243777	Mitaka
Japan	Koga General Hospital /ID# 248120	Miyazaki-shi	Miyazaki
Japan	Miyazaki Prefectural Miyazaki Hospital /ID# 251730	Miyazaki-shi	Miyazaki
Japan	University of Miyazaki Hospital /ID# 248805	Miyazaki-shi	Miyazaki
Japan	Steel Memorial Muroran Hospita /ID# 231383	Muroran-shi	Hokkaido
Japan	Japanese Red Cross Musashino Hospital /ID# 246765	Musashino-shi	Tokyo
Japan	Miyazaki Prefectural Nobeoka Hospital /ID# 248715	Nabeoka-shi	Miyazaki
Japan	Jap Red Cross Nagasaki Genbaku /ID# 245029	Nagasaki-shi	Nagasaki
Japan	Nagasaki University Hospital /ID# 245028	Nagasaki-shi	Nagasaki
Japan	Nagoya City University Hospital /ID# 256177	Nagoya shi	Aichi
Japan	Aichi Cancer Center Hospital /ID# 243785	Nagoya-shi	Aichi
Japan	Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital /ID# 242173	Nagoya-shi	Aichi
Japan	Nagoya City West Medical Center /ID# 250844	Nagoya-shi	Aichi
Japan	Nagoya University Hospital /ID# 246009	Nagoya-shi	Aichi
Japan	Naha City Hospital /ID# 242027	Naha	Okinawa
Japan	University of the Ryukyus Hospital /ID# 246821	Nakagami-gun	Okinawa
Japan	Nara Prefecture General Medical Center /ID# 254492	Nara-shi	Nara
Japan	Tsudanuma Central General Hospital /ID# 245890	Narashino-shi	Chiba
Japan	IUHW Narita Hospital /ID# 240574	Narita-shi	Chiba
Japan	Japanese Red Cross Narita Hospital /ID# 243775	Narita-shi	Chiba
Japan	Chibaken Saiseikai Narashino Hospital /ID# 254491	Narshino-shi	Chiba
Japan	Tokushima Prefecture Naruto Hospital /ID# 239095	Naruto-shi	Tokushima
Japan	Miyagi Cancer Center /ID# 241879	Natori-shi	Miyagi
Japan	Juntendo Univ Nerima Hospital /ID# 250292	Nerima-ku	Tokyo
Japan	Seijukai Hospital /ID# 248788	Neyagawa City	Osaka
Japan	Niigata University Medical & Dental Hospital /ID# 245027	Niigata-shi	Niigata
Japan	Hyogo Medical University Hospital /ID# 240569	Nishinomiya-shi	Hyogo
Japan	Hyogo?Prefectural?Nishinomiya Hospital /ID# 239354	Nishinomiya-shi	Hyogo
Japan	Obihiro kosei Hospital /ID# 252218	Obihiro-shi	Hokkaido
Japan	National Center for Geriatrics and Gerontology /ID# 251683	Obu-shi	Aichi
Japan	Odate Municipal General Hospital /ID# 258238	Odate-shi	Akita
Japan	Ogaki Municipal Hospital /ID# 239353	Ogaki-shi	Gifu
Japan	Almeida Memorial Hospital /ID# 241916	Oita City	Oita
Japan	Oita Memorial Hospital /ID# 246818	Oita-shi	Oita
Japan	Oita Prefectural Hospital /ID# 243786	Oita-shi	Oita
Japan	Duplicate_Okayama University Hospital /ID# 240887	Okayama-shi	Okayama
Japan	Duplicate_Okayama University Hospital /ID# 243755	Okayama-shi	Okayama
Japan	Japanese Red Cross Okayama Hospital /ID# 240879	Okayama-shi	Okayama
Japan	Okayama Medical Center /ID# 243759	Okayama-shi	Okayama
Japan	Nakagami Hospital /ID# 243787	Okinawa-shi	Okinawa
Japan	P_Ome Municipal General Hospital /ID# 248778	Ome	Tokyo
Japan	NHO Nagasaki Medical Center /ID# 240571	Omura-shi	Nagasaki
Japan	Omuta City Hospital /ID# 246823	Omuta-shi	Fukuoka
Japan	Kita-harima Medical Center /ID# 254490	Ono-shi	Hyogo
Japan	Daini Osaka Police Hospital /ID# 240560	Osaka-shi	Osaka
Japan	Japanese Red Cross Osaka Hospi /ID# 248784	Osaka-shi	Osaka
Japan	Kitano Hospital /ID# 248785	Osaka-shi	Osaka
Japan	National Hospital Organization Osaka National Hospital /ID# 238764	Osaka-shi	Osaka
Japan	Nippon Life Saiseikai Public Interest Foundation Nippon Life Hospital /ID# 243783	Osaka-shi	Osaka
Japan	Osaka City General Hospital /ID# 244210	Osaka-shi	Osaka
Japan	Osaka International Cancer Institute /ID# 248783	Osaka-shi	Osaka
Japan	Osaka Metropolitan University Hospital /ID# 253203	Osaka-shi	Osaka
Japan	Osaka Saiseikai Nakatsu Hospital /ID# 244209	Osaka-shi	Osaka
Japan	Otemae Hospital /ID# 250857	Osaka-shi	Osaka
Japan	Kindai University Hospital /ID# 250851	Osakasayama-shi	Osaka
Japan	Osaki Citizen Hospital /ID# 249447	Osaki-shi	Miyagi
Japan	Iwate Prefectural Isawa Hospital /ID# 246819	Oshu-shi	Iwate
Japan	Gunma Prefectural Cancer Center /ID# 242177	Ota-shi	Gunma
Japan	NHO Hiroshima-Nishi Medical center /ID# 238766	Otake-shi	Hiroshima
Japan	Saiseikai Shiga Hospital /ID# 239381	Ritto	Shiga
Japan	Saga Medical Center Koseikan /ID# 245816	Saga-shi	Saga
Japan	Nankai Medical Center /ID# 241914	Saiki-shi
Japan	Saitama City Hospital /ID# 240567	Saitama
Japan	Saitama Citizens Medical Center /ID# 252573	Saitama-shi	Saitama
Japan	Sakaide City Hospital /ID# 240563	Sakaide City	Kagawa
Japan	Nihonkai General Hospital /ID# 242024	Sakata-shi
Japan	Toho University Sakura Medical Center /ID# 252187	Sakura-shi	Chiba
Japan	Homecareclinicn-Consept /Id# 239377	Sapporo	Hokkaido
Japan	Tenshi Hospital /ID# 243051	Sapporo	Hokkaido
Japan	Aiiku Hospital /ID# 239047	Sapporo-shi	Hokkaido
Japan	Hokkaido Cancer Center /ID# 249441	Sapporo-shi	Hokkaido
Japan	Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 249446	Sapporo-shi	Hokkaido
Japan	Hokkaido University Hospital /ID# 244223	Sapporo-shi	Hokkaido
Japan	Sapporo Hokushin Hospital /ID# 241878	Sapporo-shi	Hokkaido
Japan	Sapporo Hokuyu Hospital /ID# 250856	Sapporo-shi	Hokkaido
Japan	Sapporo Medical University Hospital /ID# 252217	Sapporo-shi	Hokkaido
Japan	Sasebo City General Hospital /ID# 238759	Sasebo-shi	Nagasaki
Japan	Miyagi Chuo Hospital /ID# 259511	Sendai-shi	Miyagi
Japan	National Hospital Organization Sendai Medical Center /ID# 239384	Sendai-shi	Miyagi
Japan	Tohoku University Hospital /ID# 243757	Sendai-shi	Miyagi
Japan	Metropolitan Research and Treatment Center for Blood Disorders /ID# 231384	Setagaya Ward	Tokyo
Japan	National Center for Child Health and Development /ID# 243778	Setagaya-ku	Tokyo
Japan	National Hospital Organization Shibukawa Medical Center /ID# 245026	Shibukawa-shi	Gunma
Japan	Japanese Red Cross Medical Center /ID# 239385	Shibuya-ku	Tokyo
Japan	Duplicate_Dokkyo Medical University Hospital /ID# 246764	Shimotsuga-gun	Tochigi
Japan	Ishibashi General Hospital /ID# 243762	Shimotsuke City	Tochigi
Japan	NTT Medical Center Tokyo /ID# 240566	Shinagawa-ku	Tokyo
Japan	Center hospital of the National Center for Global Health and Medicine /ID# 256189	Shinjuku-ku	Tokyo
Japan	Tokyo Medical University Hospital /ID# 252571	Shinjuku-ku	Tokyo
Japan	Shirakawa Kosei General Hosp. /ID# 245815	Shirakawa-shi	Fukushima
Japan	Iwate Medical University Hospital /ID# 251009	Shiwa-gun	Iwate
Japan	Shizuoka Saiseikai Genaral Hospital /ID# 239722	Shizuoka-shi	Shizuoka
Japan	Tokuyama Central Hospital /ID# 242380	Shunan-shi	Yamaguchi
Japan	Kawakita General Hospital /ID# 257009	Suginami-ku	Tokyo
Japan	The Fraternity Memorial Hospital /ID# 251685	Sumida-ku	Tokyo
Japan	Tokyo Metropolitan Bokutoh Hospital /ID# 241912	Sumida-ku	Tokyo
Japan	Sunagawa City Medical Center /ID# 239382	Sunagawa	Hokkaido
Japan	Tachikawa Hospital /ID# 245878	Tachikawa
Japan	Eiju General Hospital /ID# 243763	Taito	Tokyo
Japan	Takatsuki Red Cross Hospital /ID# 266756	Takatsuki
Japan	Osaka Medical and Pharmaceutical University Hospital /ID# 249440	Takatsuki-shi	Osaka
Japan	Kumamoto Kenhoku Hospital /ID# 258240	Tamana-shi	Kumamoto
Japan	Hyogo Prefectural Tamba Medical Center /ID# 240884	Tamba-shi	Hyogo
Japan	Social Insurance Kinan Hosp /ID# 251684	Tanabe-shi	Wakayama
Japan	Hyogo College of Medicine Sasayama Medical Center /ID# 240888	Tanbasasayama-shi	Hyogo
Japan	Tatebayashi Kosei General Hospital /ID# 252188	Tatebayashi-shi	Gunma
Japan	Tenri Hospital /ID# 250855	Tenri-shi	Nara
Japan	Tokushima University Hospital /ID# 252572	Tokushima-shi	Tokushima
Japan	Toshiba General Hospital /ID# 250294	Tokyo
Japan	Ehime University Hospital /ID# 244207	Toon-shi	Ehime
Japan	JA Toride Medical Center /ID# 240573	Toride-shi	Ibaraki
Japan	Tottori Prefectural Central Ho /ID# 245877	Tottori-shi	Tottori
Japan	Toyama Hospital /ID# 243779	Toyama
Japan	Toyohashi Municipal Hospital /ID# 243784	Toyohashi-shi	Aichi
Japan	Toyokawa City Hospital /ID# 242707	Toyokawa-shi	Aichi
Japan	Toyota Memorial Hospital /ID# 242175	Toyota-shi	Aichi
Japan	University of Tsukuba Hospital /ID# 242023	Tsukuba-shi	Ibaraki
Japan	Yamaguchi University Hospital /ID# 245060	Ube-shi	Yamaguchi
Japan	Uji Tokushukai Medical Center /ID# 241876	Uji-shi	Kyoto
Japan	Kumamoto Minami National Hospital /ID# 242169	Uki	Kumamoto
Japan	Tochigi Cancer Center /ID# 249445	Utsunomiya-shi	Tochigi
Japan	Wakayama Rosai Hospital /ID# 250293	Wakayama-shi	Wakayama
Japan	Wakkanai City Hospital /ID# 243782	Wakkanai City	Hokkaido
Japan	NHO Saitama National Hospital /ID# 245061	Wako-shi	Saitama
Japan	Shonai Hospital /ID# 254514	Yamagata
Japan	Yamagata University Hospital /ID# 246763	Yamagata-shi	Yamagata
Japan	Ogori Daiichi General Hospital /ID# 246761	Yamaguchi City	Yamaguchi
Japan	Nagata Hospital /ID# 256180	Yanagawa-shi	Fukuoka
Japan	Yao Tokushukai General Hospital /ID# 247884	Yao City	Osaka
Japan	JCHO Kumamoto General Hospital /ID# 248779	Yatsushiro City	Kumamoto
Japan	St. Marianna University School of Medicine Yokohama City Seibu Hospital /ID# 266803	Yokohama	Kanagawa
Japan	Yokohama City University Medical Center /ID# 248777	Yokohama shi	Kanagawa
Japan	Kanagawa Cancer Center /ID# 246822	Yokohama-shi	Kanagawa
Japan	Saiseikai Yokohamashi Nanbu Hospital /ID# 247955	Yokohama-shi	Kanagawa
Japan	Tottori University Hospital /ID# 244215	Yonago-shi	Tottori
Japan	Yonago Medical Center /ID# 240572	Yonago-shi	Tottori
Japan	Oita University Hospital /ID# 261976	Yufu City	Oita

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 52 weeks.
Secondary	Percentage of Participants With Febrile Neutropenia and Thrombocytopenia	Percentage of participants with protocol specified febrile neutropenia and thrombocytopenia during and after treatment with venetoclax.	Up to 52 weeks
Secondary	Percentage of Participants With Tumor Lysis Syndrome (TLS)	Percentage of participants with protocol specified TLS during and after treatment with venetoclax.	Up to 52 weeks
Secondary	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.	Up to 52 weeks
Secondary	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.	Up to 52 weeks
Secondary	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.	Up to 52 weeks
Secondary	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.	Up to 52 weeks
Secondary	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.	Up to 52 weeks.
Secondary	Median Treatment Duration	Median time for duration of oral venetoclax treatment in participants with Acute Myeloid Leukemia.	Up to 52 weeks
Secondary	Median Overall Survival	Time from the date of first oral Venetoclax intake to the date of death from any cause.	Up to 52 weeks
Secondary	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).	Up to 52 weeks

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