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NCT06362044 Clinical Trial

A Study to Assess Frequency of Undetectable Minimal Residual Disease (uMRD) in Adult Participants With Chronic Lymphocytic Leukemia (CLL) Receiving Oral Venetoclax Tablets ± Intravenously (IV) Infused Rituximab in Routine Clinical Practice in Japan

Chronic Lymphocytic Leukemia Clinical Trial

Official title:
The Frequency of uMRD in Japanese Patients With CLL After 24 Months of Treatment With Venetoclax±Rituximab in the 2L+ in the Real-World Setting

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06362044
Other study ID # P24-120
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 7, 2023
Est. completion date December 31, 2024

Study information
Verified date April 2024
Source AbbVie
Contact AbbVie GK Clinical Trial Registration Desk
Phone +81-3-4577-1111
Email abbvie_jpn_info_clingov@abbvie.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Most cases of Chronic lymphocytic leukemia (CLL) remain an incurable disease with the goal of therapy being to improve quality of life and to prolong survival. This study will evaluate the participant's related outcomes and experience of CLL in adult participants who are treated in the Japan. Study participants will receive oral treatments of Venetoclax±Rituximab for CLL as prescribed by their study doctor in accordance with approved local label. Adult participants prescribed various treatments Venetoclax±Rituximab will be enrolled. Around 89 participants will be enrolled in the study in sites in Japan. Participants will receive oral venetoclax tablets ± intravenously (IV) infused rituximab treatments for CLL according to the approved local label. The overall study duration will be 27 months. There is expected to be no additional burden for participants in this trial. All study visits will occur during routine clinical practice.

Recruitment information / eligibility
Status Recruiting
Enrollment 89
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Diagnosed with relapsed/refractory (2 Line [2L]+) chronic lymphocytic leukemia (CLL) in Japan based on International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria at the time of informed consent (IC). - Treatment with Venetoclax±Rituximab for 24 months who are not treated with any other concurrent CLL treatment. - Expected to visit the hospital at + 3 months after treatment with Venetoclax±Rituximab for 24 months. Exclusion Criteria: - No data on information on the start and end dates or continuation of treatment with Venetoclax. - Participating in other clinical trials.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Japan National Cancer Center Hospital East /ID# 265970 Kashiwa Chiba

Sponsors (1)
Lead Sponsor Collaborator
AbbVie

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of Participants with Undetectable Minimal Residual Disease (uMRD) UMRD is defined as <10^-4 in peripheral blood (PB) assessed by flow cytometry (FCM). Up to 27 Months
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