Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Chronic Lymphocytic Leukemia (CLL) Participants
- description
- Participants will receive treatments for CLL in accordance with approved local label.
Primary outcomes (1)
- measure
- Percentage of Participants with Undetectable Minimal Residual Disease (uMRD)
- timeFrame
- Up to 27 Months
- description
- UMRD is defined as \<10\^-4 in peripheral blood (PB) assessed by flow cytometry (FCM).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available