A Study of the Safety and Efficacy of Venetoclax in Japanese Participants With Relapsed and Refractory Chronic Lymphocytic Leukemia (Including Small Lymphocytic Leukemia)
- Conditions
- Chronic Lymphocytic Leukemia (CLL)Small Lymphocytic Leukemia (SLL)Cancer
- Registration Number
- NCT04198415
- Lead Sponsor
- AbbVie
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 4
-Prescribed and treated with venetoclax
None
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of TLS According to Physician Assessment Approximately 37 weeks Incidence of TLS according to physician assessment.
Incidence of TLS According to Howard Criteria Approximately 37 weeks Incidence of TLS according to Howard criteria which is a classification system of TLS. Laboratory results must show two or more unusual measurements within a 24-hour period.
Incidence of Bone Marrow Suppression Approximately 37 weeks Incidence of bone marrow suppression including neutropenia (all grades) and febrile neutropenia.
Number of Participants with Dose Interruptions Approximately 37 weeks Summary data will be collected for participants with dose interruptions.
Incidence of Adverse Drug Reactions (ADR) Approximately 37 weeks Adverse drug reactions were defined as AEs of which a causal relationship with venetoclax could not be ruled out. All grades of ADRs will be collected.
Number of Prophylactic Measures Used for TLS Approximately 37 weeks Number and description of prophylactic measures used in real-world clinical practice for TLS will be collected.
Number of Participants with Dose Modifications Approximately 37 weeks Summary data will be collected for participants with dose modifications.
Number of Participants Who Discontinued Venetoclax Approximately 37 weeks Summary data will be collected for participants who discontinued treatment with venetoclax.
Best Overall Response Rate (ORR) Approximately 37 weeks Defined as complete response (CR), complete response with incomplete marrow recovery (CRi), partial response (PR), nodular partial response (nPR) according to physician assessment based on International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 guidelines and Japanese Society of Hematology clinical guidelines.
Time to Best Response Approximately 37 weeks Time to best response according to physician assessment based on International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 guidelines and Japanese Society of Hematology clinical guidelines.
Overall Incidence of Averse Drug Reactions (ADRs) of Tumor Lysis Syndrome (TLS), Bone Marrow Suppression, and Infections Approximately 37 weeks Adverse drug reactions were defined as AEs of which a causal relationship with venetoclax could not be ruled out. Overall incidence of ADRs of special interest (TLS, bone marrow suppression, and infections) will be collected.
Incidence of Infections Approximately 37 weeks Incidence of infections.
Number of Participants With Adverse Events Approximately 37 weeks An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event 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 participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug.
Number of Monitoring Measures Used for TLS Approximately 37 weeks Number and description of monitoring measures used in real-world clinical practice for TLS will be collected.
Incidence of ADRs When Venetoclax is Used Concomitantly with CYP3A Inhibitors Approximately 37 weeks Incidence of ADRs when venetoclax is used concomitantly with CYP3A inhibitors will be collected.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (102)
Nagoya City University Hospital /ID# 240820
🇯🇵Nagoya shi, Aichi, Japan
Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital /ID# 239524
🇯🇵Nagoya-shi, Aichi, Japan
Aso Iizuka Hospital /ID# 221140
🇯🇵Iizuka-shi, Fukuoka, Japan
Gifu Municipal Hospital /ID# 244231
🇯🇵Gifu-shi, Gifu, Japan
Gifu University Hospital /ID# 225295
🇯🇵Gifu-shi, Gifu, Japan
Gunmaken Saiseikai Maebashi Hospital /ID# 225887
🇯🇵Maebashi-shi, Gunma, Japan
Nara Hospital Kinki University Faculty of Medicine, /ID# 224969
🇯🇵Ikoma-shi, Nara, Japan
Kansai Medical University Hospital /ID# 224956
🇯🇵Hirakata-shi, Osaka, Japan
Ako Central Hospital /ID# 230267
🇯🇵Ako-shi, Hyogo, Japan
Japanese Red Cross Saitama Hospital /ID# 224966
🇯🇵Saitama-shi, Saitama, Japan
Medical Plaza Edogawa /ID# 244232
🇯🇵Edogawa Ward, Tokyo, Japan
Okayama Medical Center /ID# 223271
🇯🇵Okayama-shi, Okayama, Japan
Ikeda City Hospital /ID# 221139
🇯🇵Ikeda, Osaka, Japan
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital /ID# 240819
🇯🇵Bunkyo-ku, Tokyo, Japan
National Cancer Center Hospital /ID# 225296
🇯🇵Chuo-ku, Tokyo, Japan
Juntendo University Urayasu Hospital /ID# 239735
🇯🇵Urayasu-shi, Chiba, Japan
National Hospital Organization Kyushu Medical Center /ID# 244229
🇯🇵Fukuoka shi, Fukuoka, Japan
Steel Memorial Muroran Hospita /ID# 248003
🇯🇵Muroran-shi, Hokkaido, Japan
Hokkaido University Hospital /ID# 227635
🇯🇵Sapporo-shi, Hokkaido, Japan
Imamura General Hospital /ID# 228512
🇯🇵Kagoshima-shi, Kagoshima, Japan
National Hospital Organization Matsumoto Medical Center /ID# 224487
🇯🇵Matsumoto-shi, Nagano, Japan
Shizuoka Cancer Center /ID# 239523
🇯🇵Sunto-gun, Shizuoka, Japan
Tokushima University Hospital /ID# 245090
🇯🇵Tokushima-shi, Tokushima, Japan
Juntendo University Hospital /ID# 226744
🇯🇵Bunkyo-ku, Tokyo, Japan
Yamaguchi Grand Medical Center /ID# 224965
🇯🇵Hohu-shi, Yamaguchi, Japan
Nagoya University Hospital /ID# 225300
🇯🇵Nagoya-shi, Aichi, Japan
Toyohashi Municipal Hospital /ID# 227433
🇯🇵Toyohashi-shi, Aichi, Japan
Akita University Hospital /ID# 228510
🇯🇵Akita-shi, Akita, Japan
Kameda General Hospital /ID# 232142
🇯🇵Kamogawa-shi, Chiba, Japan
Chiba Aoba Municipal Hospital /ID# 224486
🇯🇵Chiba-shi, Chiba, Japan
Japanese Red Cross Narita Hospital /ID# 230276
🇯🇵Narita-shi, Chiba, Japan
National Cancer Center Hospital East /ID# 225885
🇯🇵Kashiwa-shi, Chiba, Japan
Kimitsu Chuo Hospital /ID# 243748
🇯🇵Kisarazu-shi, Chiba, Japan
Ehime University Hospital /ID# 229642
🇯🇵Toon-shi, Ehime, Japan
Fukuiken Saiseikai Hospital /ID# 239091
🇯🇵Fukui-shi, Fukui, Japan
Hamanomachi Hospital /ID# 224484
🇯🇵Fukuoka-shi, Fukuoka, Japan
Fukuoka University Hospital /ID# 239750
🇯🇵Fukuoka-shi, Fukuoka, Japan
Kyushu University Hospital /ID# 231759
🇯🇵Fukuoka-shi, Fukuoka, Japan
Kitakyushu Municipal Medical Center /ID# 239525
🇯🇵Kitakyushu-shi, Fukuoka, Japan
Tokiwakai Jyoban Hospital /ID# 239752
🇯🇵Iwaki-shi, Fukushima, Japan
Fujioka General Hospital /ID# 226840
🇯🇵Fujioka-shi, Gunma, Japan
Ogaki Municipal Hospital /ID# 225886
🇯🇵Ogaki-shi, Gifu, Japan
Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital /ID# 230274
🇯🇵Hiroshima-shi, Hiroshima, Japan
Kitami Red Cross Hospital /ID# 224190
🇯🇵Kitami-shi, Hokkaido, Japan
Gunma Prefectural Cancer Center /ID# 231760
🇯🇵Ota-shi, Gunma, Japan
Sunagawa City Medical Center /ID# 231761
🇯🇵Sunagawa, Hokkaido, Japan
Sapporo Hokushin Hospital /ID# 221137
🇯🇵Sapporo-shi, Hokkaido, Japan
Hyogo Prefectural Amagasaki General Medical Center /ID# 221138
🇯🇵Amagasaki-shi, Hyogo, Japan
Hyogo Medical University Hospital /ID# 224959
🇯🇵Nishinomiya-shi, Hyogo, Japan
Hitachi General Hospital /ID# 218530
🇯🇵Hitachi-shi, Ibaraki, Japan
JA Toride Medical Center /ID# 248004
🇯🇵Toride-shi, Ibaraki, Japan
University of Tsukuba Hospital /ID# 229738
🇯🇵Tsukuba-shi, Ibaraki, Japan
Ibaraki Prefectural Central Hospital /ID# 226745
🇯🇵Kasama-shi, Ibaraki, Japan
Ishikawa Prefectural Central Hospital /ID# 230275
🇯🇵Kanazawa-shi, Ishikawa, Japan
Iwate Prefectural Central Hospital /ID# 224191
🇯🇵Morioka-shi, Iwate, Japan
Imakiire General Hospital /ID# 229643
🇯🇵Kagoshima-shi, Kagoshima, Japan
JCHO Kyoto Kuramaguchi Medical /ID# 250196
🇯🇵Kyoto-shi, Kyoto, Japan
Imamura General Hospital /ID# 234007
🇯🇵Kagoshima-shi, Kagoshima, Japan
Medical Corporation Seijinkai Ikeda Hospital /ID# 248713
🇯🇵Kanoya-shi, Kagoshima, Japan
Shonan Kamakura General Hospital /ID# 224958
🇯🇵Kamakura-shi, Kanagawa, Japan
Yokosuka Genrl Hospital Uwamachi /ID# 225294
🇯🇵Yokosuka-shi, Kanagawa, Japan
Kyoto University Hospital /ID# 239090
🇯🇵Kyoto-shi, Kyoto, Japan
Kumamoto University Hospital /ID# 228511
🇯🇵Kumamoto shi, Kumamoto, Japan
Kawasaki Municipal Ida Hospital /ID# 226842
🇯🇵Kawasaki-shi, Kanagawa, Japan
Kumamoto Shinto General Hospital /ID# 224957
🇯🇵Kumamoto-shi, Kumamoto, Japan
University Hospital Kyoto Prefectural University of Medicine /ID# 240577
🇯🇵Kyoto-shi, Kyoto, Japan
Daini Osaka Police Hospital /ID# 243746
🇯🇵Osaka-shi, Osaka, Japan
Miyagi Cancer Center /ID# 227435
🇯🇵Natori-shi, Miyagi, Japan
Koga General Hospital /ID# 248005
🇯🇵Miyazaki-shi, Miyazaki, Japan
Miyazaki Prefectural Nobeoka Hospital /ID# 248714
🇯🇵Nabeoka-shi, Miyazaki, Japan
Showa Inan General Hospital /ID# 227431
🇯🇵Komagane-shi, Nagano, Japan
Nagasaki University Hospital /ID# 223272
🇯🇵Nagasaki-shi, Nagasaki, Japan
Niigata University Medical & Dental Hospital /ID# 244227
🇯🇵Niigata-shi, Niigata, Japan
Duplicate_Oita University Hospital /ID# 224118
🇯🇵Yufu-shi, Oita, Japan
Naha City Hospital /ID# 227432
🇯🇵Naha-shi, Okinawa, Japan
Oita Prefectural Hospital /ID# 224967
🇯🇵Oita-shi, Oita, Japan
Okayama University Hospital /ID# 229641
🇯🇵Okayama-shi, Okayama, Japan
Shiroyama Hospital /ID# 225298
🇯🇵Habikino-shi, Osaka, Japan
Osaka City General Hospital /ID# 224605
🇯🇵Osaka-shi, Osaka, Japan
Shimane Prefectural Central Ho /ID# 227437
🇯🇵Izumo-shi, Shimane, Japan
Sakai City Medical Center /ID# 224970
🇯🇵Sakai-shi, Osaka, Japan
Minami Sakai Hospital /Id# 228513
🇯🇵Sakai-sh, Osaka, Japan
Saitama Medical University International Medical Center /ID# 232528
🇯🇵Hidaka-shi, Saitama, Japan
Seirei Mikatahara General Hospital /ID# 225888
🇯🇵Hamamatsu-shi, Shizuoka, Japan
Juntendo University Shizuoka Hospital /ID# 225297
🇯🇵Izunokuni-shi, Shizuoka, Japan
Shizuoka Saiseikai Genaral Hospital /ID# 238768
🇯🇵Shizuoka-shi, Shizuoka, Japan
Tokyo Medical And Dental University Hospital /ID# 226841
🇯🇵Bunkyo-ku, Tokyo, Japan
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital /ID# 224604
🇯🇵Bunkyo-ku, Tokyo, Japan
The Cancer Institute Hospital Of JFCR /ID# 224485
🇯🇵Koto-ku, Tokyo, Japan
Toranomon Hospital /ID# 224115
🇯🇵Minato-ku, Tokyo, Japan
Edogawa Hospital /ID# 239386
🇯🇵Edogawa-ku, Tokyo, Japan
The Jikei University Hospital /ID# 227434
🇯🇵Minato-ku, Tokyo, Japan
NTT Medical Center Tokyo /ID# 224117
🇯🇵Shinagawa-ku, Tokyo, Japan
Japanese Red Cross Medical Center /ID# 225299
🇯🇵Shibuya-ku, Tokyo, Japan
Hachinohe Red Cross Hospital /ID# 250953
🇯🇵Hachinohe-shi, Japan
Fujisawa City Hospital /ID# 222585
🇯🇵Fujisawa-shi, Japan
Harasanshin Hospital /ID# 223309
🇯🇵Fukuoka-shi, Japan
Japan Community Health care Organization Tokyo Yamate Medical Center /ID# 227436
🇯🇵Shinjuku-ku, Tokyo, Japan
Okayama City General Medical Center /ID# 224116
🇯🇵Okayama, Japan
Yuri Kumiai General Hospital /ID# 248002
🇯🇵由利本荘市, Japan
Takenaka Medical Clinic /ID# 224964
🇯🇵Higashiomi-shi, Japan
Kawaguchi Municipal Medical Center /ID# 225301
🇯🇵Kawaguchi-shi, Japan