A Study of the Safety and Efficacy of Venetoclax in Japanese Participants With Relapsed and Refractory Chronic Lymphocytic Leukemia (Including Small Lymphocytic Leukemia)
VENCLL regPMOS
Post-Marketing All-Patient Drug Use Results Study for Venetoclax in Japanese Patients With Relapsed and Refractory Chronic Lymphocytic Leukemia (Including Small Lymphocytic Leukemia)
1 other identifier
observational
4
1 country
102
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Feb 2020
Typical duration for all trials
102 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 12, 2019
CompletedFirst Posted
Study publicly available on registry
December 13, 2019
CompletedStudy Start
First participant enrolled
February 3, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 21, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 21, 2022
CompletedOctober 19, 2023
October 1, 2023
2.7 years
December 12, 2019
October 18, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (15)
Number of Participants With Adverse Events
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.
Approximately 37 weeks
Overall Incidence of Averse Drug Reactions (ADRs) of Tumor Lysis Syndrome (TLS), Bone Marrow Suppression, and Infections
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.
Approximately 37 weeks
Incidence of Adverse Drug Reactions (ADR)
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.
Approximately 37 weeks
Incidence of TLS According to Physician Assessment
Incidence of TLS according to physician assessment.
Approximately 37 weeks
Incidence of TLS According to Howard Criteria
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.
Approximately 37 weeks
Incidence of Bone Marrow Suppression
Incidence of bone marrow suppression including neutropenia (all grades) and febrile neutropenia.
Approximately 37 weeks
Incidence of Infections
Incidence of infections.
Approximately 37 weeks
Incidence of ADRs When Venetoclax is Used Concomitantly with CYP3A Inhibitors
Incidence of ADRs when venetoclax is used concomitantly with CYP3A inhibitors will be collected.
Approximately 37 weeks
Number of Prophylactic Measures Used for TLS
Number and description of prophylactic measures used in real-world clinical practice for TLS will be collected.
Approximately 37 weeks
Number of Monitoring Measures Used for TLS
Number and description of monitoring measures used in real-world clinical practice for TLS will be collected.
Approximately 37 weeks
Number of Participants with Dose Modifications
Summary data will be collected for participants with dose modifications.
Approximately 37 weeks
Number of Participants with Dose Interruptions
Summary data will be collected for participants with dose interruptions.
Approximately 37 weeks
Number of Participants Who Discontinued Venetoclax
Summary data will be collected for participants who discontinued treatment with venetoclax.
Approximately 37 weeks
Best Overall Response Rate (ORR)
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.
Approximately 37 weeks
Time to Best Response
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.
Approximately 37 weeks
Study Arms (1)
Venetoclax Participants
Participants prescribed and treated with venetoclax.
Eligibility Criteria
All participants treated with venetoclax per the local label.
You may qualify if:
- Prescribed and treated with venetoclax
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (102)
Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital /ID# 239524
Nagoya, Aichi-ken, 466-8650, Japan
Nagoya University Hospital /ID# 225300
Nagoya, Aichi-ken, 4668560, Japan
Nagoya City University Hospital /ID# 240820
Nagoya, Aichi-ken, 467-8602, Japan
Toyohashi Municipal Hospital /ID# 227433
Toyohashi, Aichi-ken, 441-8570, Japan
Akita University Hospital /ID# 228510
Akita, Akita, 010-8543, Japan
Chiba Aoba Municipal Hospital /ID# 224486
Chiba, Chiba, 260-0852, Japan
Kameda General Hospital /ID# 232142
Kamogawa-shi, Chiba, 296-8602, Japan
National Cancer Center Hospital East /ID# 225885
Kashiwa-shi, Chiba, 277-8577, Japan
Kimitsu Chuo Hospital /ID# 243748
Kisarazu-shi, Chiba, 292-8535, Japan
Japanese Red Cross Narita Hospital /ID# 230276
Narita-shi, Chiba, 286-8523, Japan
Juntendo University Urayasu Hospital /ID# 239735
Urayasu-shi, Chiba, 279-0021, Japan
Ehime University Hospital /ID# 229642
Toon-shi, Ehime, 791-0295, Japan
Fukuiken Saiseikai Hospital /ID# 239091
Fukui-shi, Fukui, 918-8235, Japan
Hamanomachi Hospital /ID# 224484
Fukuoka, Fukuoka, 810-8539, Japan
National Hospital Organization Kyushu Medical Center /ID# 244229
Fukuoka, Fukuoka, 810-8563, Japan
Kyushu University Hospital /ID# 231759
Fukuoka, Fukuoka, 812-8582, Japan
Fukuoka University Hospital /ID# 239750
Fukuoka, Fukuoka, 814-0180, Japan
Aso Iizuka Hospital /ID# 221140
Iizuka-shi, Fukuoka, 820-8505, Japan
Kitakyushu Municipal Medical Center /ID# 239525
Kitakyushu-shi, Fukuoka, 802-8561, Japan
Tokiwakai Jyoban Hospital /ID# 239752
Iwaki, Fukushima, 972-8322, Japan
Gifu Municipal Hospital /ID# 244231
Gifu, Gifu, 500-8513, Japan
Gifu University Hospital /ID# 225295
Gifu, Gifu, 501-1194, Japan
Ogaki Municipal Hospital /ID# 225886
Ogaki-shi, Gifu, 503-8502, Japan
Fujioka General Hospital /ID# 226840
Fujioka-shi, Gunma, 375-0015, Japan
Gunmaken Saiseikai Maebashi Hospital /ID# 225887
Maebashi, Gunma, 371-0821, Japan
Gunma Prefectural Cancer Center /ID# 231760
Ota-shi, Gunma, 373-8550, Japan
Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital /ID# 230274
Hiroshima, Hiroshima, 730-8619, Japan
Kitami Red Cross Hospital /ID# 224190
Kitami-shi, Hokkaido, 090-0026, Japan
Steel Memorial Muroran Hospita /ID# 248003
Muroran-shi, Hokkaido, 050-0076, Japan
Sapporo Hokushin Hospital /ID# 221137
Sapporo, Hokkaido, 004-0052, Japan
Hokkaido University Hospital /ID# 227635
Sapporo, Hokkaido, 060-8648, Japan
Sunagawa City Medical Center /ID# 231761
Sunagawa, Hokkaido, 073-0164, Japan
Ako Central Hospital /ID# 230267
Ako-shi, Hyōgo, 678-0241, Japan
Hyogo Prefectural Amagasaki General Medical Center /ID# 221138
Amagasaki-shi, Hyōgo, 660-8550, Japan
Hyogo Medical University Hospital /ID# 224959
Nishinomiya-shi, Hyōgo, 663-8501, Japan
Hitachi General Hospital /ID# 218530
Hitachi-shi, Ibaraki, 317-0077, Japan
Ibaraki Prefectural Central Hospital /ID# 226745
Kasama-shi, Ibaraki, 309-1793, Japan
JA Toride Medical Center /ID# 248004
Toride-shi, Ibaraki, 302-0022, Japan
University of Tsukuba Hospital /ID# 229738
Tsukuba, Ibaraki, 305-8576, Japan
Ishikawa Prefectural Central Hospital /ID# 230275
Kanazawa, Ishikawa-ken, 920-8530, Japan
Iwate Prefectural Central Hospital /ID# 224191
Morioka, Iwate, 020-0066, Japan
Imakiire General Hospital /ID# 229643
Kagoshima, Kagoshima-ken, 890-0051, Japan
Imamura General Hospital /ID# 228512
Kagoshima, Kagoshima-ken, 890-0064, Japan
Imamura General Hospital /ID# 234007
Kagoshima, Kagoshima-ken, 890-0064, Japan
Medical Corporation Seijinkai Ikeda Hospital /ID# 248713
Kanoya-shi, Kagoshima-ken, 893-0024, Japan
Shonan Kamakura General Hospital /ID# 224958
Kamakura-shi, Kanagawa, 247-8533, Japan
Kawasaki Municipal Ida Hospital /ID# 226842
Kawasaki-shi, Kanagawa, 211-0035, Japan
Yokosuka Genrl Hospital Uwamachi /ID# 225294
Yokosuka-shi, Kanagawa, 238-8567, Japan
Kumamoto University Hospital /ID# 228511
Kumamoto, Kumamoto, 8608556, Japan
Kumamoto Shinto General Hospital /ID# 224957
Kumamoto, Kumamoto, 862-8655, Japan
University Hospital Kyoto Prefectural University of Medicine /ID# 240577
Kyoto, Kyoto, 602-8566, Japan
JCHO Kyoto Kuramaguchi Medical /ID# 250196
Kyoto, Kyoto, 603-8151, Japan
Kyoto University Hospital /ID# 239090
Kyoto, Kyoto, 606-8507, Japan
Miyagi Cancer Center /ID# 227435
Natori-shi, Miyagi, 981-1293, Japan
Koga General Hospital /ID# 248005
Miyazaki, Miyazaki, 8800041, Japan
Miyazaki Prefectural Nobeoka Hospital /ID# 248714
Nabeoka-shi, Miyazaki, 882-0835, Japan
Showa Inan General Hospital /ID# 227431
Komagane-shi, Nagano, 3994117, Japan
National Hospital Organization Matsumoto Medical Center /ID# 224487
Matsumoto-shi, Nagano, 3998701, Japan
Nagasaki University Hospital /ID# 223272
Nagasaki, Nagasaki, 852-8501, Japan
Nara Hospital Kinki University Faculty of Medicine, /ID# 224969
Ikoma-shi, Nara, 630-0227, Japan
Niigata University Medical & Dental Hospital /ID# 244227
Niigata, Niigata, 951-8520, Japan
Oita Prefectural Hospital /ID# 224967
Ōita, Oita Prefecture, 870-0855, Japan
Duplicate_Oita University Hospital /ID# 224118
Yufu-shi, Oita Prefecture, 879-5593, Japan
Okayama University Hospital /ID# 229641
Okayama, Okayama-ken, 700-8558, Japan
Okayama Medical Center /ID# 223271
Okayama, Okayama-ken, 701-1192, Japan
Naha City Hospital /ID# 227432
Naha, Okinawa, 902-8511, Japan
Shiroyama Hospital /ID# 225298
Habikino-shi, Osaka, 583-0872, Japan
Kansai Medical University Hospital /ID# 224956
Hirakata-shi, Osaka, 573-1191, Japan
Ikeda City Hospital /ID# 221139
Ikeda, Osaka, 563-8510, Japan
Osaka City General Hospital /ID# 224605
Osaka, Osaka, 534-0021, Japan
Daini Osaka Police Hospital /ID# 243746
Osaka, Osaka, 543-8922, Japan
Sakai City Medical Center /ID# 224970
Sakai-shi, Osaka, 593-8304, Japan
Minami Sakai Hospital /Id# 228513
Sakai-sh, Osaka, 599-8233, Japan
Saitama Medical University International Medical Center /ID# 232528
Hidaka-shi, Saitama, 350-1298, Japan
Japanese Red Cross Saitama Hospital /ID# 224966
Saitama-shi, Saitama, 338-8553, Japan
Shimane Prefectural Central Ho /ID# 227437
Izumo-shi, Shimane, 693-8555, Japan
Seirei Mikatahara General Hospital /ID# 225888
Hamamatsu, Shizuoka, 433-8558, Japan
Juntendo University Shizuoka Hospital /ID# 225297
Izunokuni-shi, Shizuoka, 410-2295, Japan
Shizuoka Saiseikai Genaral Hospital /ID# 238768
Shizuoka, Shizuoka, 422-8527, Japan
Shizuoka Cancer Center /ID# 239523
Sunto-gun, Shizuoka, 411-8777, Japan
Tokushima University Hospital /ID# 245090
Tokushima, Tokushima, 770-8503, Japan
Juntendo University Hospital /ID# 226744
Bunkyo-ku, Tokyo, 113-8431, Japan
Tokyo Medical And Dental University Hospital /ID# 226841
Bunkyo-ku, Tokyo, 113-8519, Japan
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital /ID# 224604
Bunkyo-ku, Tokyo, 113-8677, Japan
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital /ID# 240819
Bunkyo-ku, Tokyo, 113-8677, Japan
National Cancer Center Hospital /ID# 225296
Chuo-ku, Tokyo, 104-0045, Japan
Medical Plaza Edogawa /ID# 244232
Edogawa Ward, Tokyo, 133-0052, Japan
Edogawa Hospital /ID# 239386
Edogawa-ku, Tokyo, 133-0052, Japan
The Cancer Institute Hospital Of JFCR /ID# 224485
Koto-ku, Tokyo, 135-8550, Japan
Toranomon Hospital /ID# 224115
Minato-ku, Tokyo, 105-8470, Japan
The Jikei University Hospital /ID# 227434
Minato-ku, Tokyo, 105-8471, Japan
Japanese Red Cross Medical Center /ID# 225299
Shibuya-ku, Tokyo, 150-8935, Japan
NTT Medical Center Tokyo /ID# 224117
Shinagawa-ku, Tokyo, 141-8625, Japan
Japan Community Health care Organization Tokyo Yamate Medical Center /ID# 227436
Shinjuku-ku, Tokyo, 169-0073, Japan
Yamaguchi Grand Medical Center /ID# 224965
Hohu-shi, Yamaguchi, 747-8511, Japan
Fujisawa City Hospital /ID# 222585
Fujisawa-shi, 251-8550, Japan
Harasanshin Hospital /ID# 223309
Fukuoka, 812-0033, Japan
Hachinohe Red Cross Hospital /ID# 250953
Hachinohe-shi, 039-1104, Japan
Takenaka Medical Clinic /ID# 224964
Higashiomi-shi, 527-0121, Japan
Kawaguchi Municipal Medical Center /ID# 225301
Kawaguchi-shi, 333-0833, Japan
Okayama City General Medical Center /ID# 224116
Okayama, 700-8557, Japan
Yuri Kumiai General Hospital /ID# 248002
Yurihonjō, 015-0051, Japan
Related Publications (1)
Ito T, Kamimura T, Kiguchi T, Kato K, Takenaka R, Kobayashi M, Ito A, Sakai M, Izutsu K. Venetoclax treatment for chronic lymphocytic leukemia/small lymphocytic leukemia in Japan: post-marketing surveillance. Int J Hematol. 2024 Nov;120(5):613-620. doi: 10.1007/s12185-024-03832-x. Epub 2024 Aug 21.
PMID: 39167348DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
ABBVIE INC.
AbbVie
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 12, 2019
First Posted
December 13, 2019
Study Start
February 3, 2020
Primary Completion
October 21, 2022
Study Completion
October 21, 2022
Last Updated
October 19, 2023
Record last verified: 2023-10