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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06362044

Enrollment

Registered

2024-04-12

Start date

2023-06-07

Completion date

2024-12-31

Last updated

2025-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Lymphocytic Leukemia

Keywords

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

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Countries

Japan

Outcome results