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

Cancer Clinical Trial

— VENCLL regPMOS  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04198415
• Other study ID #: P19-830
• Status: Completed
• Start date: February 3, 2020
• Est. completion date: October 21, 2022

Study information

• Verified date: October 2023
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: October 21, 2022
• Est. primary completion date: October 21, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

-Prescribed and treated with venetoclax Exclusion Criteria: None

Related Conditions & MeSH terms

• Cancer
• Chronic Lymphocytic Leukemia (CLL)
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid
• Small Lymphocytic Leukemia (SLL)

Locations

Country	Name	City	State
Japan	Yuri Kumiai General Hospital /ID# 248002	?????
Japan	Akita University Hospital /ID# 228510	Akita-shi	Akita
Japan	Ako Central Hospital /ID# 230267	Ako-shi	Hyogo
Japan	Hyogo Prefectural Amagasaki General Medical Center /ID# 221138	Amagasaki-shi	Hyogo
Japan	Juntendo University Hospital /ID# 226744	Bunkyo-ku	Tokyo
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	Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital /ID# 240819	Bunkyo-ku	Tokyo
Japan	Chiba Aoba Municipal Hospital /ID# 224486	Chiba-shi	Chiba
Japan	National Cancer Center Hospital /ID# 225296	Chuo-ku	Tokyo
Japan	Medical Plaza Edogawa /ID# 244232	Edogawa Ward	Tokyo
Japan	Edogawa Hospital /ID# 239386	Edogawa-ku	Tokyo
Japan	Fujioka General Hospital /ID# 226840	Fujioka-shi	Gunma
Japan	Fujisawa City Hospital /ID# 222585	Fujisawa-shi
Japan	Fukuiken Saiseikai Hospital /ID# 239091	Fukui-shi	Fukui
Japan	National Hospital Organization Kyushu Medical Center /ID# 244229	Fukuoka shi	Fukuoka
Japan	Fukuoka University Hospital /ID# 239750	Fukuoka-shi	Fukuoka
Japan	Hamanomachi Hospital /ID# 224484	Fukuoka-shi	Fukuoka
Japan	Harasanshin Hospital /ID# 223309	Fukuoka-shi
Japan	Kyushu University Hospital /ID# 231759	Fukuoka-shi	Fukuoka
Japan	Gifu Municipal Hospital /ID# 244231	Gifu-shi	Gifu
Japan	Gifu University Hospital /ID# 225295	Gifu-shi	Gifu
Japan	Shiroyama Hospital /ID# 225298	Habikino-shi	Osaka
Japan	Hachinohe Red Cross Hospital /ID# 250953	Hachinohe-shi
Japan	Seirei Mikatahara General Hospital /ID# 225888	Hamamatsu-shi	Shizuoka
Japan	Saitama Medical University International Medical Center /ID# 232528	Hidaka-shi	Saitama
Japan	Takenaka Medical Clinic /ID# 224964	Higashiomi-shi
Japan	Kansai Medical University Hospital /ID# 224956	Hirakata-shi	Osaka
Japan	Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital /ID# 230274	Hiroshima-shi	Hiroshima
Japan	Hitachi General Hospital /ID# 218530	Hitachi-shi	Ibaraki
Japan	Yamaguchi Grand Medical Center /ID# 224965	Hohu-shi	Yamaguchi
Japan	Aso Iizuka Hospital /ID# 221140	Iizuka-shi	Fukuoka
Japan	Ikeda City Hospital /ID# 221139	Ikeda	Osaka
Japan	Nara Hospital Kinki University Faculty of Medicine, /ID# 224969	Ikoma-shi	Nara
Japan	Tokiwakai Jyoban Hospital /ID# 239752	Iwaki-shi	Fukushima
Japan	Shimane Prefectural Central Ho /ID# 227437	Izumo-shi	Shimane
Japan	Juntendo University Shizuoka Hospital /ID# 225297	Izunokuni-shi	Shizuoka
Japan	Imakiire General Hospital /ID# 229643	Kagoshima-shi	Kagoshima
Japan	Imamura General Hospital /ID# 228512	Kagoshima-shi	Kagoshima
Japan	Imamura General Hospital /ID# 234007	Kagoshima-shi	Kagoshima
Japan	Shonan Kamakura General Hospital /ID# 224958	Kamakura-shi	Kanagawa
Japan	Kameda General Hospital /ID# 232142	Kamogawa-shi	Chiba
Japan	Ishikawa Prefectural Central Hospital /ID# 230275	Kanazawa-shi	Ishikawa
Japan	Medical Corporation Seijinkai Ikeda Hospital /ID# 248713	Kanoya-shi	Kagoshima
Japan	Ibaraki Prefectural Central Hospital /ID# 226745	Kasama-shi	Ibaraki
Japan	National Cancer Center Hospital East /ID# 225885	Kashiwa-shi	Chiba
Japan	Kawaguchi Municipal Medical Center /ID# 225301	Kawaguchi-shi
Japan	Kawasaki Municipal Ida Hospital /ID# 226842	Kawasaki-shi	Kanagawa
Japan	Kimitsu Chuo Hospital /ID# 243748	Kisarazu-shi	Chiba
Japan	Kitakyushu Municipal Medical Center /ID# 239525	Kitakyushu-shi	Fukuoka
Japan	Kitami Red Cross Hospital /ID# 224190	Kitami-shi	Hokkaido
Japan	Showa Inan General Hospital /ID# 227431	Komagane-shi	Nagano
Japan	The Cancer Institute Hospital Of JFCR /ID# 224485	Koto-ku	Tokyo
Japan	Kumamoto University Hospital /ID# 228511	Kumamoto shi	Kumamoto
Japan	Kumamoto Shinto General Hospital /ID# 224957	Kumamoto-shi	Kumamoto
Japan	JCHO Kyoto Kuramaguchi Medical /ID# 250196	Kyoto-shi	Kyoto
Japan	Kyoto University Hospital /ID# 239090	Kyoto-shi	Kyoto
Japan	University Hospital Kyoto Prefectural University of Medicine /ID# 240577	Kyoto-shi	Kyoto
Japan	Gunmaken Saiseikai Maebashi Hospital /ID# 225887	Maebashi-shi	Gunma
Japan	National Hospital Organization Matsumoto Medical Center /ID# 224487	Matsumoto-shi	Nagano
Japan	The Jikei University Hospital /ID# 227434	Minato-ku	Tokyo
Japan	Toranomon Hospital /ID# 224115	Minato-ku	Tokyo
Japan	Koga General Hospital /ID# 248005	Miyazaki-shi	Miyazaki
Japan	Iwate Prefectural Central Hospital /ID# 224191	Morioka-shi	Iwate
Japan	Steel Memorial Muroran Hospita /ID# 248003	Muroran-shi	Hokkaido
Japan	Miyazaki Prefectural Nobeoka Hospital /ID# 248714	Nabeoka-shi	Miyazaki
Japan	Nagasaki University Hospital /ID# 223272	Nagasaki-shi	Nagasaki
Japan	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	Nagoya University Hospital /ID# 225300	Nagoya-shi	Aichi
Japan	Naha City Hospital /ID# 227432	Naha-shi	Okinawa
Japan	Japanese Red Cross Narita Hospital /ID# 230276	Narita-shi	Chiba
Japan	Miyagi Cancer Center /ID# 227435	Natori-shi	Miyagi
Japan	Niigata University Medical & Dental Hospital /ID# 244227	Niigata-shi	Niigata
Japan	Hyogo Medical University Hospital /ID# 224959	Nishinomiya-shi	Hyogo
Japan	Ogaki Municipal Hospital /ID# 225886	Ogaki-shi	Gifu
Japan	Oita Prefectural Hospital /ID# 224967	Oita-shi	Oita
Japan	Okayama City General Medical Center /ID# 224116	Okayama
Japan	Okayama Medical Center /ID# 223271	Okayama-shi	Okayama
Japan	Okayama University Hospital /ID# 229641	Okayama-shi	Okayama
Japan	Daini Osaka Police Hospital /ID# 243746	Osaka-shi	Osaka
Japan	Osaka City General Hospital /ID# 224605	Osaka-shi	Osaka
Japan	Gunma Prefectural Cancer Center /ID# 231760	Ota-shi	Gunma
Japan	Japanese Red Cross Saitama Hospital /ID# 224966	Saitama-shi	Saitama
Japan	Minami Sakai Hospital /Id# 228513	Sakai-sh	Osaka
Japan	Sakai City Medical Center /ID# 224970	Sakai-shi	Osaka
Japan	Hokkaido University Hospital /ID# 227635	Sapporo-shi	Hokkaido
Japan	Sapporo Hokushin Hospital /ID# 221137	Sapporo-shi	Hokkaido
Japan	Japanese Red Cross Medical Center /ID# 225299	Shibuya-ku	Tokyo
Japan	NTT Medical Center Tokyo /ID# 224117	Shinagawa-ku	Tokyo
Japan	Japan Community Health care Organization Tokyo Yamate Medical Center /ID# 227436	Shinjuku-ku	Tokyo
Japan	Shizuoka Saiseikai Genaral Hospital /ID# 238768	Shizuoka-shi	Shizuoka
Japan	Sunagawa City Medical Center /ID# 231761	Sunagawa	Hokkaido
Japan	Shizuoka Cancer Center /ID# 239523	Sunto-gun	Shizuoka
Japan	Tokushima University Hospital /ID# 245090	Tokushima-shi	Tokushima
Japan	Ehime University Hospital /ID# 229642	Toon-shi	Ehime
Japan	JA Toride Medical Center /ID# 248004	Toride-shi	Ibaraki
Japan	Toyohashi Municipal Hospital /ID# 227433	Toyohashi-shi	Aichi
Japan	University of Tsukuba Hospital /ID# 229738	Tsukuba-shi	Ibaraki
Japan	Juntendo University Urayasu Hospital /ID# 239735	Urayasu-shi	Chiba
Japan	Yokosuka Genrl Hospital Uwamachi /ID# 225294	Yokosuka-shi	Kanagawa
Japan	Duplicate_Oita University Hospital /ID# 224118	Yufu-shi	Oita

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Incidence of TLS According to Physician Assessment	Incidence of TLS according to physician assessment.	Approximately 37 weeks
Primary	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
Primary	Incidence of Bone Marrow Suppression	Incidence of bone marrow suppression including neutropenia (all grades) and febrile neutropenia.	Approximately 37 weeks
Primary	Incidence of Infections	Incidence of infections.	Approximately 37 weeks
Primary	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
Primary	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
Primary	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
Primary	Number of Participants with Dose Modifications	Summary data will be collected for participants with dose modifications.	Approximately 37 weeks
Primary	Number of Participants with Dose Interruptions	Summary data will be collected for participants with dose interruptions.	Approximately 37 weeks
Primary	Number of Participants Who Discontinued Venetoclax	Summary data will be collected for participants who discontinued treatment with venetoclax.	Approximately 37 weeks
Primary	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
Primary	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

External Links

•   clinical study report synopsis