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

NCT06362044 | Completed

• 1 other identifier: P24-120
• Study Type: observational
• Target: 89
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Lymphocytic Leukemia

Keywords

Chronic Lymphocytic Leukemia; CLL; Venetoclax; Rituximab; ABT-199

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Chronic Lymphocytic Leukemia (CLL) Participants

Participants will receive treatments for CLL in accordance with approved local label.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult participants diagnosed with chronic lymphocytic leukemia (CLL) treated with Venetoclax±Rituximab and attend to a regular follow up visit at a Japanese participating hospital will be eligible to participate in the study.

You may qualify if:

• 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.

You may not qualify if:

• No data on information on the start and end dates or continuation of treatment with Venetoclax.
• Participating in other clinical trials.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (1)

National Cancer Center Hospital East /ID# 265970

Kashiwa-shi, Chiba, 277-8577, Japan

Location

Related Links

• Clinical Study Report Synopsis

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2024
• First Posted: April 12, 2024
• Study Start: June 7, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: November 25, 2025

Record last verified: 2025-11

Locations

JP (1)