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

Completed

• 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

Study Timeline

• Study First Submitted: 2019-12-12
• Study First Submitted QC: 2019-12-12
• Study First Posted: 2019-12-13
• Study Start: 2020-02-03
• Primary Completion: 2022-10-21
• Study Completion: 2022-10-21
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-18
• Last Update Posted: 2023-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

-Prescribed and treated with venetoclax

Exclusion Criteria

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.

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

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

Chiba Aoba Municipal Hospital /ID# 224486; 🇯🇵 Chiba-shi, Chiba, Japan

Kameda General Hospital /ID# 232142; 🇯🇵 Kamogawa-shi, Chiba, Japan

National Cancer Center Hospital East /ID# 225885; 🇯🇵 Kashiwa-shi, Chiba, Japan

Kimitsu Chuo Hospital /ID# 243748; 🇯🇵 Kisarazu-shi, Chiba, Japan

Japanese Red Cross Narita Hospital /ID# 230276; 🇯🇵 Narita-shi, Chiba, Japan

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