Clinical trial NCT04198415: A Study of the Safety and Efficacy of Venetoclax in Japanese Participants With Relapsed and Refractory Chronic Lymphocytic Leukemia (Including Small Lymphocytic Leukemia)
Official title: Post-Marketing All-Patient Drug Use Results Study for Venetoclax in Japanese Patients With Relapsed and Refractory Chronic Lymphocytic Leukemia (Including Small Lymphocytic Leukemia)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Chronic Lymphocytic Leukemia (CLL)
Small Lymphocytic Leukemia (SLL)
Keywords: Cancer
Chronic Lymphocytic Leukemia (CLL)
Small Lymphocytic Leukemia (SLL)
Relapsed/Refractory
Venetoclax
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2019-12-13
Enrollment: 4
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All participants treated with venetoclax per the local label.

Brief summary: This study will collect real-world safety and efficacy data from Japanese relapse/refractory chronic lymphocytic leukemia (CLL) and small lymphocytic leukemia (SLL) participants treated with venetoclax.


Eligibility criteria: Inclusion Criteria:

-Prescribed and treated with venetoclax

Exclusion Criteria:

None

Primary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: Approximately 37 weeks
measure: Overall Incidence of Averse Drug Reactions (ADRs) of Tumor Lysis Syndrome (TLS), Bone Marrow Suppression, and Infections
timeFrame: Approximately 37 weeks
measure: Incidence of Adverse Drug Reactions (ADR)
timeFrame: Approximately 37 weeks
measure: Incidence of TLS According to Physician Assessment
timeFrame: Approximately 37 weeks
measure: Incidence of TLS According to Howard Criteria
timeFrame: Approximately 37 weeks
measure: Incidence of Bone Marrow Suppression
timeFrame: Approximately 37 weeks
measure: Incidence of Infections
timeFrame: Approximately 37 weeks
measure: Incidence of ADRs When Venetoclax is Used Concomitantly with CYP3A Inhibitors
timeFrame: Approximately 37 weeks
measure: Number of Prophylactic Measures Used for TLS
timeFrame: Approximately 37 weeks
measure: Number of Monitoring Measures Used for TLS
timeFrame: Approximately 37 weeks
measure: Number of Participants with Dose Modifications
timeFrame: Approximately 37 weeks
measure: Number of Participants with Dose Interruptions
timeFrame: Approximately 37 weeks
measure: Number of Participants Who Discontinued Venetoclax
timeFrame: Approximately 37 weeks
measure: Best Overall Response Rate (ORR)
timeFrame: Approximately 37 weeks
measure: Time to Best Response
timeFrame: Approximately 37 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Nagoya shi
country: Japan
facility: Nagoya City University Hospital /ID# 240820
state: Aichi
city: Nagoya-shi
country: Japan
facility: Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital /ID# 239524
state: Aichi
city: Nagoya-shi
country: Japan
facility: Nagoya University Hospital /ID# 225300
state: Aichi
city: Toyohashi-shi
country: Japan
facility: Toyohashi Municipal Hospital /ID# 227433
state: Aichi
city: Akita-shi
country: Japan
facility: Akita University Hospital /ID# 228510
state: Akita
city: Chiba-shi
country: Japan
facility: Chiba Aoba Municipal Hospital /ID# 224486
state: Chiba
city: Kamogawa-shi
country: Japan
facility: Kameda General Hospital /ID# 232142
state: Chiba
city: Kashiwa-shi
country: Japan
facility: National Cancer Center Hospital East /ID# 225885
state: Chiba
city: Kisarazu-shi
country: Japan
facility: Kimitsu Chuo Hospital /ID# 243748
state: Chiba
city: Narita-shi
country: Japan
facility: Japanese Red Cross Narita Hospital /ID# 230276
state: Chiba
city: Urayasu-shi
country: Japan
facility: Juntendo University Urayasu Hospital /ID# 239735
state: Chiba
city: Toon-shi
country: Japan
facility: Ehime University Hospital /ID# 229642
state: Ehime
city: Fukui-shi
country: Japan
facility: Fukuiken Saiseikai Hospital /ID# 239091
state: Fukui
city: Fukuoka shi
country: Japan
facility: National Hospital Organization Kyushu Medical Center /ID# 244229
state: Fukuoka
city: Fukuoka-shi
country: Japan
facility: Hamanomachi Hospital /ID# 224484
state: Fukuoka
city: Fukuoka-shi
country: Japan
facility: Kyushu University Hospital /ID# 231759
state: Fukuoka
city: Fukuoka-shi
country: Japan
facility: Fukuoka University Hospital /ID# 239750
state: Fukuoka
city: Iizuka-shi
country: Japan
facility: Aso Iizuka Hospital /ID# 221140
state: Fukuoka
city: Kitakyushu-shi
country: Japan
facility: Kitakyushu Municipal Medical Center /ID# 239525
state: Fukuoka
city: Iwaki-shi
country: Japan
facility: Tokiwakai Jyoban Hospital /ID# 239752
state: Fukushima
city: Gifu-shi
country: Japan
facility: Gifu Municipal Hospital /ID# 244231
state: Gifu
city: Gifu-shi
country: Japan
facility: Gifu University Hospital /ID# 225295
state: Gifu
city: Ogaki-shi
country: Japan
facility: Ogaki Municipal Hospital /ID# 225886
state: Gifu
city: Fujioka-shi
country: Japan
facility: Fujioka General Hospital /ID# 226840
state: Gunma
city: Maebashi-shi
country: Japan
facility: Gunmaken Saiseikai Maebashi Hospital /ID# 225887
state: Gunma
city: Ota-shi
country: Japan
facility: Gunma Prefectural Cancer Center /ID# 231760
state: Gunma
city: Hiroshima-shi
country: Japan
facility: Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital /ID# 230274
state: Hiroshima
city: Kitami-shi
country: Japan
facility: Kitami Red Cross Hospital /ID# 224190
state: Hokkaido
city: Muroran-shi
country: Japan
facility: Steel Memorial Muroran Hospita /ID# 248003
state: Hokkaido
city: Sapporo-shi
country: Japan
facility: Sapporo Hokushin Hospital /ID# 221137
state: Hokkaido
city: Sapporo-shi
country: Japan
facility: Hokkaido University Hospital /ID# 227635
state: Hokkaido
city: Sunagawa
country: Japan
facility: Sunagawa City Medical Center /ID# 231761
state: Hokkaido
city: Ako-shi
country: Japan
facility: Ako Central Hospital /ID# 230267
state: Hyogo
city: Amagasaki-shi
country: Japan
facility: Hyogo Prefectural Amagasaki General Medical Center /ID# 221138
state: Hyogo
city: Nishinomiya-shi
country: Japan
facility: Hyogo Medical University Hospital /ID# 224959
state: Hyogo
city: Hitachi-shi
country: Japan
facility: Hitachi General Hospital /ID# 218530
state: Ibaraki
city: Kasama-shi
country: Japan
facility: Ibaraki Prefectural Central Hospital /ID# 226745
state: Ibaraki
city: Toride-shi
country: Japan
facility: JA Toride Medical Center /ID# 248004
state: Ibaraki
city: Tsukuba-shi
country: Japan
facility: University of Tsukuba Hospital /ID# 229738
state: Ibaraki
city: Kanazawa-shi
country: Japan
facility: Ishikawa Prefectural Central Hospital /ID# 230275
state: Ishikawa
city: Morioka-shi
country: Japan
facility: Iwate Prefectural Central Hospital /ID# 224191
state: Iwate
city: Kagoshima-shi
country: Japan
facility: Imakiire General Hospital /ID# 229643
state: Kagoshima
city: Kagoshima-shi
country: Japan
facility: Imamura General Hospital /ID# 228512
state: Kagoshima
city: Kagoshima-shi
country: Japan
facility: Imamura General Hospital /ID# 234007
state: Kagoshima
city: Kanoya-shi
country: Japan
facility: Medical Corporation Seijinkai Ikeda Hospital /ID# 248713
state: Kagoshima
city: Kamakura-shi
country: Japan
facility: Shonan Kamakura General Hospital /ID# 224958
state: Kanagawa
city: Kawasaki-shi
country: Japan
facility: Kawasaki Municipal Ida Hospital /ID# 226842
state: Kanagawa
city: Yokosuka-shi
country: Japan
facility: Yokosuka Genrl Hospital Uwamachi /ID# 225294
state: Kanagawa
city: Kumamoto shi
country: Japan
facility: Kumamoto University Hospital /ID# 228511
state: Kumamoto
city: Kumamoto-shi
country: Japan
facility: Kumamoto Shinto General Hospital /ID# 224957
state: Kumamoto
city: Kyoto-shi
country: Japan
facility: University Hospital Kyoto Prefectural University of Medicine /ID# 240577
state: Kyoto
city: Kyoto-shi
country: Japan
facility: JCHO Kyoto Kuramaguchi Medical /ID# 250196
state: Kyoto
city: Kyoto-shi
country: Japan
facility: Kyoto University Hospital /ID# 239090
state: Kyoto
city: Natori-shi
country: Japan
facility: Miyagi Cancer Center /ID# 227435
state: Miyagi
city: Miyazaki-shi
country: Japan
facility: Koga General Hospital /ID# 248005
state: Miyazaki
city: Nabeoka-shi
country: Japan
facility: Miyazaki Prefectural Nobeoka Hospital /ID# 248714
state: Miyazaki
city: Komagane-shi
country: Japan
facility: Showa Inan General Hospital /ID# 227431
state: Nagano
city: Matsumoto-shi
country: Japan
facility: National Hospital Organization Matsumoto Medical Center /ID# 224487
state: Nagano
city: Nagasaki-shi
country: Japan
facility: Nagasaki University Hospital /ID# 223272
state: Nagasaki
city: Ikoma-shi
country: Japan
facility: Nara Hospital Kinki University Faculty of Medicine, /ID# 224969
state: Nara
city: Niigata-shi
country: Japan
facility: Niigata University Medical & Dental Hospital /ID# 244227
state: Niigata
city: Oita-shi
country: Japan
facility: Oita Prefectural Hospital /ID# 224967
state: Oita
city: Yufu-shi
country: Japan
facility: Duplicate_Oita University Hospital /ID# 224118
state: Oita
city: Okayama-shi
country: Japan
facility: Okayama University Hospital /ID# 229641
state: Okayama
city: Okayama-shi
country: Japan
facility: Okayama Medical Center /ID# 223271
state: Okayama
city: Naha-shi
country: Japan
facility: Naha City Hospital /ID# 227432
state: Okinawa
city: Habikino-shi
country: Japan
facility: Shiroyama Hospital /ID# 225298
state: Osaka
city: Hirakata-shi
country: Japan
facility: Kansai Medical University Hospital /ID# 224956
state: Osaka
city: Ikeda
country: Japan
facility: Ikeda City Hospital /ID# 221139
state: Osaka
city: Osaka-shi
country: Japan
facility: Osaka City General Hospital /ID# 224605
state: Osaka
city: Osaka-shi
country: Japan
facility: Daini Osaka Police Hospital /ID# 243746
state: Osaka
city: Sakai-shi
country: Japan
facility: Sakai City Medical Center /ID# 224970
state: Osaka
city: Sakai-sh
country: Japan
facility: Minami Sakai Hospital /Id# 228513
state: Osaka
city: Hidaka-shi
country: Japan
facility: Saitama Medical University International Medical Center /ID# 232528
state: Saitama
city: Saitama-shi
country: Japan
facility: Japanese Red Cross Saitama Hospital /ID# 224966
state: Saitama
city: Izumo-shi
country: Japan
facility: Shimane Prefectural Central Ho /ID# 227437
state: Shimane
city: Hamamatsu-shi
country: Japan
facility: Seirei Mikatahara General Hospital /ID# 225888
state: Shizuoka
city: Izunokuni-shi
country: Japan
facility: Juntendo University Shizuoka Hospital /ID# 225297
state: Shizuoka
city: Shizuoka-shi
country: Japan
facility: Shizuoka Saiseikai Genaral Hospital /ID# 238768
state: Shizuoka
city: Sunto-gun
country: Japan
facility: Shizuoka Cancer Center /ID# 239523
state: Shizuoka
city: Tokushima-shi
country: Japan
facility: Tokushima University Hospital /ID# 245090
state: Tokushima
city: Bunkyo-ku
country: Japan
facility: Juntendo University Hospital /ID# 226744
state: Tokyo
city: Bunkyo-ku
country: Japan
facility: Tokyo Medical And Dental University Hospital /ID# 226841
state: Tokyo
city: Bunkyo-ku
country: Japan
facility: Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital /ID# 224604
state: Tokyo
city: Bunkyo-ku
country: Japan
facility: Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital /ID# 240819
state: Tokyo
city: Chuo-ku
country: Japan
facility: National Cancer Center Hospital /ID# 225296
state: Tokyo
city: Edogawa Ward
country: Japan
facility: Medical Plaza Edogawa /ID# 244232
state: Tokyo
city: Edogawa-ku
country: Japan
facility: Edogawa Hospital /ID# 239386
state: Tokyo
city: Koto-ku
country: Japan
facility: The Cancer Institute Hospital Of JFCR /ID# 224485
state: Tokyo
city: Minato-ku
country: Japan
facility: Toranomon Hospital /ID# 224115
state: Tokyo
city: Minato-ku
country: Japan
facility: The Jikei University Hospital /ID# 227434
state: Tokyo
city: Shibuya-ku
country: Japan
facility: Japanese Red Cross Medical Center /ID# 225299
state: Tokyo
city: Shinagawa-ku
country: Japan
facility: NTT Medical Center Tokyo /ID# 224117
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Japan Community Health care Organization Tokyo Yamate Medical Center /ID# 227436
state: Tokyo
city: Hohu-shi
country: Japan
facility: Yamaguchi Grand Medical Center /ID# 224965
state: Yamaguchi
city: Fujisawa-shi
country: Japan
facility: Fujisawa City Hospital /ID# 222585
city: Fukuoka-shi
country: Japan
facility: Harasanshin Hospital /ID# 223309
city: Hachinohe-shi
country: Japan
facility: Hachinohe Red Cross Hospital /ID# 250953
city: Higashiomi-shi
country: Japan
facility: Takenaka Medical Clinic /ID# 224964
city: Kawaguchi-shi
country: Japan
facility: Kawaguchi Municipal Medical Center /ID# 225301
city: Okayama
country: Japan
facility: Okayama City General Medical Center /ID# 224116
city: 由利本荘市
country: Japan
facility: Yuri Kumiai General Hospital /ID# 248002
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: