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CancerVENCLL regPMOSNCT04198415

A Study of the Safety and Efficacy of Venetoclax in Japanese Participants With Relapsed and Refractory Chronic Lymphocytic Leukemia (Including Small Lymphocytic Leukemia)

An observational study of Cancer and Chronic Lymphocytic Leukemia (CLL), run by AbbVie at 102 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age
How many people
4 participants
Where
102 sitesJapan
Study dates
3 Feb 2020to 21 Oct 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: All participants treated with venetoclax per the local label.

Who may be able to join

  • -Prescribed and treated with venetoclax

Who cannot join

  • None

Trial locations and contacts

102 sites in 1 country.

102 sites in 1 country

Japan102 sites

  • Akita University Hospital /ID# 228510

    Akita, Akita, 010-8543

  • Ako Central Hospital /ID# 230267

    Ako-shi, Hyōgo, 678-0241

  • Hyogo Prefectural Amagasaki General Medical Center /ID# 221138

    Amagasaki-shi, Hyōgo, 660-8550

  • Juntendo University Hospital /ID# 226744

    Bunkyo-ku, Tokyo, 113-8431

  • Tokyo Medical And Dental University Hospital /ID# 226841

    Bunkyo-ku, Tokyo, 113-8519

  • Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital /ID# 224604

    Bunkyo-ku, Tokyo, 113-8677

  • Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital /ID# 240819

    Bunkyo-ku, Tokyo, 113-8677

  • Chiba Aoba Municipal Hospital /ID# 224486

    Chiba, Chiba, 260-0852

  • National Cancer Center Hospital /ID# 225296

    Chuo-ku, Tokyo, 104-0045

  • Medical Plaza Edogawa /ID# 244232

    Edogawa Ward, Tokyo, 133-0052

  • Edogawa Hospital /ID# 239386

    Edogawa-ku, Tokyo, 133-0052

  • Fujioka General Hospital /ID# 226840

    Fujioka-shi, Gunma, 375-0015

  • Fujisawa City Hospital /ID# 222585

    Fujisawa-shi, 251-8550

  • Fukuiken Saiseikai Hospital /ID# 239091

    Fukui-shi, Fukui, 918-8235

  • Hamanomachi Hospital /ID# 224484

    Fukuoka, Fukuoka, 810-8539

  • National Hospital Organization Kyushu Medical Center /ID# 244229

    Fukuoka, Fukuoka, 810-8563

  • Kyushu University Hospital /ID# 231759

    Fukuoka, Fukuoka, 812-8582

  • Fukuoka University Hospital /ID# 239750

    Fukuoka, Fukuoka, 814-0180

  • Harasanshin Hospital /ID# 223309

    Fukuoka, 812-0033

  • Gifu Municipal Hospital /ID# 244231

    Gifu, Gifu, 500-8513

  • Gifu University Hospital /ID# 225295

    Gifu, Gifu, 501-1194

  • Shiroyama Hospital /ID# 225298

    Habikino-shi, Osaka, 583-0872

  • Hachinohe Red Cross Hospital /ID# 250953

    Hachinohe-shi, 039-1104

  • Seirei Mikatahara General Hospital /ID# 225888

    Hamamatsu, Shizuoka, 433-8558

  • Saitama Medical University International Medical Center /ID# 232528

    Hidaka-shi, Saitama, 350-1298

  • Takenaka Medical Clinic /ID# 224964

    Higashiomi-shi, 527-0121

  • Kansai Medical University Hospital /ID# 224956

    Hirakata-shi, Osaka, 573-1191

  • Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital /ID# 230274

    Hiroshima, Hiroshima, 730-8619

  • Hitachi General Hospital /ID# 218530

    Hitachi-shi, Ibaraki, 317-0077

  • Yamaguchi Grand Medical Center /ID# 224965

    Hohu-shi, Yamaguchi, 747-8511

  • Aso Iizuka Hospital /ID# 221140

    Iizuka-shi, Fukuoka, 820-8505

  • Ikeda City Hospital /ID# 221139

    Ikeda, Osaka, 563-8510

  • Nara Hospital Kinki University Faculty of Medicine, /ID# 224969

    Ikoma-shi, Nara, 630-0227

  • Tokiwakai Jyoban Hospital /ID# 239752

    Iwaki, Fukushima, 972-8322

  • Shimane Prefectural Central Ho /ID# 227437

    Izumo-shi, Shimane, 693-8555

  • Juntendo University Shizuoka Hospital /ID# 225297

    Izunokuni-shi, Shizuoka, 410-2295

  • Imakiire General Hospital /ID# 229643

    Kagoshima, Kagoshima-ken, 890-0051

  • Imamura General Hospital /ID# 228512

    Kagoshima, Kagoshima-ken, 890-0064

  • Imamura General Hospital /ID# 234007

    Kagoshima, Kagoshima-ken, 890-0064

  • Shonan Kamakura General Hospital /ID# 224958

    Kamakura-shi, Kanagawa, 247-8533

  • Kameda General Hospital /ID# 232142

    Kamogawa-shi, Chiba, 296-8602

  • Ishikawa Prefectural Central Hospital /ID# 230275

    Kanazawa, Ishikawa-ken, 920-8530

  • Medical Corporation Seijinkai Ikeda Hospital /ID# 248713

    Kanoya-shi, Kagoshima-ken, 893-0024

  • Ibaraki Prefectural Central Hospital /ID# 226745

    Kasama-shi, Ibaraki, 309-1793

  • National Cancer Center Hospital East /ID# 225885

    Kashiwa-shi, Chiba, 277-8577

  • Kawaguchi Municipal Medical Center /ID# 225301

    Kawaguchi-shi, 333-0833

  • Kawasaki Municipal Ida Hospital /ID# 226842

    Kawasaki-shi, Kanagawa, 211-0035

  • Kimitsu Chuo Hospital /ID# 243748

    Kisarazu-shi, Chiba, 292-8535

  • Kitakyushu Municipal Medical Center /ID# 239525

    Kitakyushu-shi, Fukuoka, 802-8561

  • Kitami Red Cross Hospital /ID# 224190

    Kitami-shi, Hokkaido, 090-0026

  • Showa Inan General Hospital /ID# 227431

    Komagane-shi, Nagano, 3994117

  • The Cancer Institute Hospital Of JFCR /ID# 224485

    Koto-ku, Tokyo, 135-8550

  • Kumamoto University Hospital /ID# 228511

    Kumamoto, Kumamoto, 8608556

  • Kumamoto Shinto General Hospital /ID# 224957

    Kumamoto, Kumamoto, 862-8655

  • University Hospital Kyoto Prefectural University of Medicine /ID# 240577

    Kyoto, Kyoto, 602-8566

  • JCHO Kyoto Kuramaguchi Medical /ID# 250196

    Kyoto, Kyoto, 603-8151

  • Kyoto University Hospital /ID# 239090

    Kyoto, Kyoto, 606-8507

  • Gunmaken Saiseikai Maebashi Hospital /ID# 225887

    Maebashi, Gunma, 371-0821

  • National Hospital Organization Matsumoto Medical Center /ID# 224487

    Matsumoto-shi, Nagano, 3998701

  • Toranomon Hospital /ID# 224115

    Minato-ku, Tokyo, 105-8470

  • The Jikei University Hospital /ID# 227434

    Minato-ku, Tokyo, 105-8471

  • Koga General Hospital /ID# 248005

    Miyazaki, Miyazaki, 8800041

  • Iwate Prefectural Central Hospital /ID# 224191

    Morioka, Iwate, 020-0066

  • Steel Memorial Muroran Hospita /ID# 248003

    Muroran-shi, Hokkaido, 050-0076

  • Miyazaki Prefectural Nobeoka Hospital /ID# 248714

    Nabeoka-shi, Miyazaki, 882-0835

  • Nagasaki University Hospital /ID# 223272

    Nagasaki, Nagasaki, 852-8501

  • Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital /ID# 239524

    Nagoya, Aichi-ken, 466-8650

  • Nagoya University Hospital /ID# 225300

    Nagoya, Aichi-ken, 4668560

  • Nagoya City University Hospital /ID# 240820

    Nagoya, Aichi-ken, 467-8602

  • Naha City Hospital /ID# 227432

    Naha, Okinawa, 902-8511

  • Japanese Red Cross Narita Hospital /ID# 230276

    Narita-shi, Chiba, 286-8523

  • Miyagi Cancer Center /ID# 227435

    Natori-shi, Miyagi, 981-1293

  • Niigata University Medical & Dental Hospital /ID# 244227

    Niigata, Niigata, 951-8520

  • Hyogo Medical University Hospital /ID# 224959

    Nishinomiya-shi, Hyōgo, 663-8501

  • Ogaki Municipal Hospital /ID# 225886

    Ogaki-shi, Gifu, 503-8502

  • Oita Prefectural Hospital /ID# 224967

    Ōita, Oita Prefecture, 870-0855

  • Okayama University Hospital /ID# 229641

    Okayama, Okayama-ken, 700-8558

  • Okayama Medical Center /ID# 223271

    Okayama, Okayama-ken, 701-1192

  • Okayama City General Medical Center /ID# 224116

    Okayama, 700-8557

  • Osaka City General Hospital /ID# 224605

    Osaka, Osaka, 534-0021

  • Daini Osaka Police Hospital /ID# 243746

    Osaka, Osaka, 543-8922

  • Gunma Prefectural Cancer Center /ID# 231760

    Ota-shi, Gunma, 373-8550

  • Japanese Red Cross Saitama Hospital /ID# 224966

    Saitama-shi, Saitama, 338-8553

  • Minami Sakai Hospital /Id# 228513

    Sakai-sh, Osaka, 599-8233

  • Sakai City Medical Center /ID# 224970

    Sakai-shi, Osaka, 593-8304

  • Sapporo Hokushin Hospital /ID# 221137

    Sapporo, Hokkaido, 004-0052

  • Hokkaido University Hospital /ID# 227635

    Sapporo, Hokkaido, 060-8648

  • Japanese Red Cross Medical Center /ID# 225299

    Shibuya-ku, Tokyo, 150-8935

  • NTT Medical Center Tokyo /ID# 224117

    Shinagawa-ku, Tokyo, 141-8625

  • Japan Community Health care Organization Tokyo Yamate Medical Center /ID# 227436

    Shinjuku-ku, Tokyo, 169-0073

  • Shizuoka Saiseikai Genaral Hospital /ID# 238768

    Shizuoka, Shizuoka, 422-8527

  • Sunagawa City Medical Center /ID# 231761

    Sunagawa, Hokkaido, 073-0164

  • Shizuoka Cancer Center /ID# 239523

    Sunto-gun, Shizuoka, 411-8777

  • Tokushima University Hospital /ID# 245090

    Tokushima, Tokushima, 770-8503

  • Ehime University Hospital /ID# 229642

    Toon-shi, Ehime, 791-0295

  • JA Toride Medical Center /ID# 248004

    Toride-shi, Ibaraki, 302-0022

  • Toyohashi Municipal Hospital /ID# 227433

    Toyohashi, Aichi-ken, 441-8570

  • University of Tsukuba Hospital /ID# 229738

    Tsukuba, Ibaraki, 305-8576

  • Juntendo University Urayasu Hospital /ID# 239735

    Urayasu-shi, Chiba, 279-0021

  • Yokosuka Genrl Hospital Uwamachi /ID# 225294

    Yokosuka-shi, Kanagawa, 238-8567

  • Duplicate_Oita University Hospital /ID# 224118

    Yufu-shi, Oita Prefecture, 879-5593

  • Yuri Kumiai General Hospital /ID# 248002

    Yurihonjō, 015-0051

Other trials in Japan

About this study

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)

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.

Keywords
Cancer, Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Leukemia (SLL), Relapsed/Refractory, Venetoclax
Medical subject headings
Neoplasms, Leukemia, Lymphocytic, Chronic, B-Cell, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04198415
Study groupRoleWhat they receive
Venetoclax ParticipantsParticipants prescribed and treated with venetoclax.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Approximately 37 weeks

  2. 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.

    Measured: Approximately 37 weeks

  3. 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.

    Measured: Approximately 37 weeks

  4. Incidence of TLS According to Physician Assessment

    Incidence of TLS according to physician assessment.

    Measured: Approximately 37 weeks

  5. 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.

    Measured: Approximately 37 weeks

  6. Incidence of Bone Marrow Suppression

    Incidence of bone marrow suppression including neutropenia (all grades) and febrile neutropenia.

    Measured: Approximately 37 weeks

  7. Incidence of Infections

    Incidence of infections.

    Measured: Approximately 37 weeks

  8. 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.

    Measured: Approximately 37 weeks

  9. Number of Prophylactic Measures Used for TLS

    Number and description of prophylactic measures used in real-world clinical practice for TLS will be collected.

    Measured: Approximately 37 weeks

  10. Number of Monitoring Measures Used for TLS

    Number and description of monitoring measures used in real-world clinical practice for TLS will be collected.

    Measured: Approximately 37 weeks

  11. Number of Participants with Dose Modifications

    Summary data will be collected for participants with dose modifications.

    Measured: Approximately 37 weeks

  12. Number of Participants with Dose Interruptions

    Summary data will be collected for participants with dose interruptions.

    Measured: Approximately 37 weeks

  13. Number of Participants Who Discontinued Venetoclax

    Summary data will be collected for participants who discontinued treatment with venetoclax.

    Measured: Approximately 37 weeks

  14. 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.

    Measured: Approximately 37 weeks

  15. 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.

    Measured: Approximately 37 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Dec 2019
  2. Study start3 Feb 2020
  3. Primary completion21 Oct 2022
  4. Study completion21 Oct 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
4 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04198415
Sponsor's protocol ID
P19-830
Acronym
VENCLL regPMOS
Status last verified
Oct 2023
First submitted
12 Dec 2019
Last updated
19 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 39167348

Questions about this trial

What is this clinical trial studying?

An observational study of Cancer and Chronic Lymphocytic Leukemia (CLL), run by AbbVie at 102 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 102 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Adverse Events (time frame: Approximately 37 weeks). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04198415, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2023.

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