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)

October 18, 2023 updated by: AbbVie

Post-Marketing All-Patient Drug Use Results Study for Venetoclax in Japanese Patients With Relapsed and Refractory Chronic Lymphocytic Leukemia (Including Small Lymphocytic Leukemia)

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Fujisawa-shi, Japan, 251-8550
        • Fujisawa City Hospital /ID# 222585
      • Fukuoka-shi, Japan, 812-0033
        • Harasanshin Hospital /ID# 223309
      • Hachinohe-shi, Japan, 039-1104
        • Hachinohe Red Cross Hospital /ID# 250953
      • Higashiomi-shi, Japan, 527-0121
        • Takenaka Medical Clinic /ID# 224964
      • Kawaguchi-shi, Japan, 333-0833
        • Kawaguchi Municipal Medical Center /ID# 225301
      • Okayama, Japan, 700-8557
        • Okayama City General Medical Center /ID# 224116
      • 由利本荘市, Japan, 015-0051
        • Yuri Kumiai General Hospital /ID# 248002
    • Aichi
      • Nagoya shi, Aichi, Japan, 467-8602
        • Nagoya City University Hospital /ID# 240820
      • Nagoya-shi, Aichi, Japan, 466-8650
        • Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital /ID# 239524
      • Nagoya-shi, Aichi, Japan, 4668560
        • Nagoya University Hospital /ID# 225300
      • Toyohashi-shi, Aichi, Japan, 441-8570
        • Toyohashi Municipal Hospital /ID# 227433
    • Akita
      • Akita-shi, Akita, Japan, 010-8543
        • Akita University Hospital /ID# 228510
    • Chiba
      • Chiba-shi, Chiba, Japan, 260-0852
        • Chiba Aoba Municipal Hospital /ID# 224486
      • Kamogawa-shi, Chiba, Japan, 296-8602
        • Kameda General Hospital /ID# 232142
      • Kashiwa-shi, Chiba, Japan, 277-8577
        • National Cancer Center Hospital East /ID# 225885
      • Kisarazu-shi, Chiba, Japan, 292-8535
        • Kimitsu Chuo Hospital /ID# 243748
      • Narita-shi, Chiba, Japan, 286-8523
        • Japanese Red Cross Narita Hospital /ID# 230276
      • Urayasu-shi, Chiba, Japan, 279-0021
        • Juntendo University Urayasu Hospital /ID# 239735
    • Ehime
      • Toon-shi, Ehime, Japan, 791-0295
        • Ehime University Hospital /ID# 229642
    • Fukui
      • Fukui-shi, Fukui, Japan, 918-8235
        • Fukuiken Saiseikai Hospital /ID# 239091
    • Fukuoka
      • Fukuoka shi, Fukuoka, Japan, 810-8563
        • National Hospital Organization Kyushu Medical Center /ID# 244229
      • Fukuoka-shi, Fukuoka, Japan, 810-8539
        • Hamanomachi Hospital /ID# 224484
      • Fukuoka-shi, Fukuoka, Japan, 812-8582
        • Kyushu University Hospital /ID# 231759
      • Fukuoka-shi, Fukuoka, Japan, 814-0180
        • Fukuoka University Hospital /ID# 239750
      • Iizuka-shi, Fukuoka, Japan, 820-8505
        • Aso Iizuka Hospital /ID# 221140
      • Kitakyushu-shi, Fukuoka, Japan, 802-8561
        • Kitakyushu Municipal Medical Center /ID# 239525
    • Fukushima
      • Iwaki-shi, Fukushima, Japan, 972-8322
        • Tokiwakai Jyoban Hospital /ID# 239752
    • Gifu
      • Gifu-shi, Gifu, Japan, 500-8513
        • Gifu Municipal Hospital /ID# 244231
      • Gifu-shi, Gifu, Japan, 501-1194
        • Gifu University Hospital /ID# 225295
      • Ogaki-shi, Gifu, Japan, 503-8502
        • Ogaki Municipal Hospital /ID# 225886
    • Gunma
      • Fujioka-shi, Gunma, Japan, 375-0015
        • Fujioka General Hospital /ID# 226840
      • Maebashi-shi, Gunma, Japan, 371-0821
        • Gunmaken Saiseikai Maebashi Hospital /ID# 225887
      • Ota-shi, Gunma, Japan, 373-8550
        • Gunma Prefectural Cancer Center /ID# 231760
    • Hiroshima
      • Hiroshima-shi, Hiroshima, Japan, 730-8619
        • Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital /ID# 230274
    • Hokkaido
      • Kitami-shi, Hokkaido, Japan, 090-0026
        • Kitami Red Cross Hospital /ID# 224190
      • Muroran-shi, Hokkaido, Japan, 050-0076
        • Steel Memorial Muroran Hospita /ID# 248003
      • Sapporo-shi, Hokkaido, Japan, 004-0052
        • Sapporo Hokushin Hospital /ID# 221137
      • Sapporo-shi, Hokkaido, Japan, 060-8648
        • Hokkaido University Hospital /ID# 227635
      • Sunagawa, Hokkaido, Japan, 073-0164
        • Sunagawa City Medical Center /ID# 231761
    • Hyogo
      • Ako-shi, Hyogo, Japan, 678-0241
        • Ako Central Hospital /ID# 230267
      • Amagasaki-shi, Hyogo, Japan, 660-8550
        • Hyogo Prefectural Amagasaki General Medical Center /ID# 221138
      • Nishinomiya-shi, Hyogo, Japan, 663-8501
        • Hyogo Medical University Hospital /ID# 224959
    • Ibaraki
      • Hitachi-shi, Ibaraki, Japan, 317-0077
        • Hitachi General Hospital /ID# 218530
      • Kasama-shi, Ibaraki, Japan, 309-1793
        • Ibaraki Prefectural Central Hospital /ID# 226745
      • Toride-shi, Ibaraki, Japan, 302-0022
        • JA Toride Medical Center /ID# 248004
      • Tsukuba-shi, Ibaraki, Japan, 305-8576
        • University of Tsukuba Hospital /ID# 229738
    • Ishikawa
      • Kanazawa-shi, Ishikawa, Japan, 920-8530
        • Ishikawa Prefectural Central Hospital /ID# 230275
    • Iwate
      • Morioka-shi, Iwate, Japan, 020-0066
        • Iwate Prefectural Central Hospital /ID# 224191
    • Kagoshima
      • Kagoshima-shi, Kagoshima, Japan, 890-0051
        • Imakiire General Hospital /ID# 229643
      • Kagoshima-shi, Kagoshima, Japan, 890-0064
        • Imamura General Hospital /ID# 228512
      • Kagoshima-shi, Kagoshima, Japan, 890-0064
        • Imamura General Hospital /ID# 234007
      • Kanoya-shi, Kagoshima, Japan, 893-0024
        • Medical Corporation Seijinkai Ikeda Hospital /ID# 248713
    • Kanagawa
      • Kamakura-shi, Kanagawa, Japan, 247-8533
        • Shonan Kamakura General Hospital /ID# 224958
      • Kawasaki-shi, Kanagawa, Japan, 211-0035
        • Kawasaki Municipal Ida Hospital /ID# 226842
      • Yokosuka-shi, Kanagawa, Japan, 238-8567
        • Yokosuka Genrl Hospital Uwamachi /ID# 225294
    • Kumamoto
      • Kumamoto shi, Kumamoto, Japan, 8608556
        • Kumamoto University Hospital /ID# 228511
      • Kumamoto-shi, Kumamoto, Japan, 862-8655
        • Kumamoto Shinto General Hospital /ID# 224957
    • Kyoto
      • Kyoto-shi, Kyoto, Japan, 602-8566
        • University Hospital Kyoto Prefectural University of Medicine /ID# 240577
      • Kyoto-shi, Kyoto, Japan, 603-8151
        • JCHO Kyoto Kuramaguchi Medical /ID# 250196
      • Kyoto-shi, Kyoto, Japan, 606-8507
        • Kyoto University Hospital /ID# 239090
    • Miyagi
      • Natori-shi, Miyagi, Japan, 981-1293
        • Miyagi Cancer Center /ID# 227435
    • Miyazaki
      • Miyazaki-shi, Miyazaki, Japan, 8800041
        • Koga General Hospital /ID# 248005
      • Nabeoka-shi, Miyazaki, Japan, 882-0835
        • Miyazaki Prefectural Nobeoka Hospital /ID# 248714
    • Nagano
      • Komagane-shi, Nagano, Japan, 3994117
        • Showa Inan General Hospital /ID# 227431
      • Matsumoto-shi, Nagano, Japan, 3998701
        • National Hospital Organization Matsumoto Medical Center /ID# 224487
    • Nagasaki
      • Nagasaki-shi, Nagasaki, Japan, 852-8501
        • Nagasaki University Hospital /ID# 223272
    • Nara
      • Ikoma-shi, Nara, Japan, 630-0227
        • Nara Hospital Kinki University Faculty of Medicine, /ID# 224969
    • Niigata
      • Niigata-shi, Niigata, Japan, 951-8520
        • Niigata University Medical & Dental Hospital /ID# 244227
    • Oita
      • Oita-shi, Oita, Japan, 870-0855
        • Oita Prefectural Hospital /ID# 224967
      • Yufu-shi, Oita, Japan, 879-5593
        • Duplicate_Oita University Hospital /ID# 224118
    • Okayama
      • Okayama-shi, Okayama, Japan, 700-8558
        • Okayama University Hospital /ID# 229641
      • Okayama-shi, Okayama, Japan, 701-1192
        • Okayama Medical Center /ID# 223271
    • Okinawa
      • Naha-shi, Okinawa, Japan, 902-8511
        • Naha City Hospital /ID# 227432
    • Osaka
      • Habikino-shi, Osaka, Japan, 583-0872
        • Shiroyama Hospital /ID# 225298
      • Hirakata-shi, Osaka, Japan, 573-1191
        • Kansai Medical University Hospital /ID# 224956
      • Ikeda, Osaka, Japan, 563-8510
        • Ikeda City Hospital /ID# 221139
      • Osaka-shi, Osaka, Japan, 534-0021
        • Osaka City General Hospital /ID# 224605
      • Osaka-shi, Osaka, Japan, 543-8922
        • Daini Osaka Police Hospital /ID# 243746
      • Sakai-sh, Osaka, Japan, 599-8233
        • Minami Sakai Hospital /Id# 228513
      • Sakai-shi, Osaka, Japan, 593-8304
        • Sakai City Medical Center /ID# 224970
    • Saitama
      • Hidaka-shi, Saitama, Japan, 350-1298
        • Saitama Medical University International Medical Center /ID# 232528
      • Saitama-shi, Saitama, Japan, 338-8553
        • Japanese Red Cross Saitama Hospital /ID# 224966
    • Shimane
      • Izumo-shi, Shimane, Japan, 693-8555
        • Shimane Prefectural Central Ho /ID# 227437
    • Shizuoka
      • Hamamatsu-shi, Shizuoka, Japan, 433-8558
        • Seirei Mikatahara General Hospital /ID# 225888
      • Izunokuni-shi, Shizuoka, Japan, 410-2295
        • Juntendo University Shizuoka Hospital /ID# 225297
      • Shizuoka-shi, Shizuoka, Japan, 422-8527
        • Shizuoka Saiseikai Genaral Hospital /ID# 238768
      • Sunto-gun, Shizuoka, Japan, 411-8777
        • Shizuoka Cancer Center /ID# 239523
    • Tokushima
      • Tokushima-shi, Tokushima, Japan, 770-8503
        • Tokushima University Hospital /ID# 245090
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 113-8431
        • Juntendo University Hospital /ID# 226744
      • Bunkyo-ku, Tokyo, Japan, 113-8519
        • Tokyo Medical And Dental University Hospital /ID# 226841
      • Bunkyo-ku, Tokyo, Japan, 113-8677
        • Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital /ID# 224604
      • Bunkyo-ku, Tokyo, Japan, 113-8677
        • Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital /ID# 240819
      • Chuo-ku, Tokyo, Japan, 104-0045
        • National Cancer Center Hospital /ID# 225296
      • Edogawa Ward, Tokyo, Japan, 133-0052
        • Medical Plaza Edogawa /ID# 244232
      • Edogawa-ku, Tokyo, Japan, 133-0052
        • Edogawa Hospital /ID# 239386
      • Koto-ku, Tokyo, Japan, 135-8550
        • The Cancer Institute Hospital Of JFCR /ID# 224485
      • Minato-ku, Tokyo, Japan, 105-8470
        • Toranomon Hospital /ID# 224115
      • Minato-ku, Tokyo, Japan, 105-8471
        • The Jikei University Hospital /ID# 227434
      • Shibuya-ku, Tokyo, Japan, 150-8935
        • Japanese Red Cross Medical Center /ID# 225299
      • Shinagawa-ku, Tokyo, Japan, 141-8625
        • NTT Medical Center Tokyo /ID# 224117
      • Shinjuku-ku, Tokyo, Japan, 169-0073
        • Japan Community Health care Organization Tokyo Yamate Medical Center /ID# 227436
    • Yamaguchi
      • Hohu-shi, Yamaguchi, Japan, 747-8511
        • Yamaguchi Grand Medical Center /ID# 224965

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All participants treated with venetoclax per the local label.

Description

Inclusion Criteria:

-Prescribed and treated with venetoclax

Exclusion Criteria:

None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Venetoclax Participants
Participants prescribed and treated with venetoclax.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Adverse Events
Time Frame: 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.
Approximately 37 weeks
Overall Incidence of Averse Drug Reactions (ADRs) of Tumor Lysis Syndrome (TLS), Bone Marrow Suppression, and Infections
Time Frame: 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.
Approximately 37 weeks
Incidence of Adverse Drug Reactions (ADR)
Time Frame: 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.
Approximately 37 weeks
Incidence of TLS According to Physician Assessment
Time Frame: Approximately 37 weeks
Incidence of TLS according to physician assessment.
Approximately 37 weeks
Incidence of TLS According to Howard Criteria
Time Frame: 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.
Approximately 37 weeks
Incidence of Bone Marrow Suppression
Time Frame: Approximately 37 weeks
Incidence of bone marrow suppression including neutropenia (all grades) and febrile neutropenia.
Approximately 37 weeks
Incidence of Infections
Time Frame: Approximately 37 weeks
Incidence of infections.
Approximately 37 weeks
Incidence of ADRs When Venetoclax is Used Concomitantly with CYP3A Inhibitors
Time Frame: Approximately 37 weeks
Incidence of ADRs when venetoclax is used concomitantly with CYP3A inhibitors will be collected.
Approximately 37 weeks
Number of Prophylactic Measures Used for TLS
Time Frame: Approximately 37 weeks
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
Time Frame: Approximately 37 weeks
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
Time Frame: Approximately 37 weeks
Summary data will be collected for participants with dose modifications.
Approximately 37 weeks
Number of Participants with Dose Interruptions
Time Frame: Approximately 37 weeks
Summary data will be collected for participants with dose interruptions.
Approximately 37 weeks
Number of Participants Who Discontinued Venetoclax
Time Frame: Approximately 37 weeks
Summary data will be collected for participants who discontinued treatment with venetoclax.
Approximately 37 weeks
Best Overall Response Rate (ORR)
Time Frame: 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.
Approximately 37 weeks
Time to Best Response
Time Frame: 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.
Approximately 37 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Investigators

  • Study Director: ABBVIE INC., AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 3, 2020

Primary Completion (Actual)

October 21, 2022

Study Completion (Actual)

October 21, 2022

Study Registration Dates

First Submitted

December 12, 2019

First Submitted That Met QC Criteria

December 12, 2019

First Posted (Actual)

December 13, 2019

Study Record Updates

Last Update Posted (Actual)

October 19, 2023

Last Update Submitted That Met QC Criteria

October 18, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P19-830

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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