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

April 9, 2024 updated by: AbbVie

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

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

89

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Japan
    • Chiba
      • Kashiwa, Chiba, Japan, 277-8577
        • Recruiting
        • National Cancer Center Hospital East /ID# 265970

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Chronic Lymphocytic Leukemia (CLL) Participants
Participants will receive treatments for CLL in accordance with approved local label.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Investigators

  • Study Director: ABBVIE INC., AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 7, 2023

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

April 9, 2024

First Submitted That Met QC Criteria

April 9, 2024

First Posted (Actual)

April 12, 2024

Study Record Updates

Last Update Posted (Actual)

April 12, 2024

Last Update Submitted That Met QC Criteria

April 9, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P24-120

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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