Chronic Lymphocytic LeukemiaNCT06362044
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
An observational study of Chronic Lymphocytic Leukemia, run by AbbVie at 1 site in Japan.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Lymphocytic Leukemia
- How many people
- 89 participants
- Where
- 1 siteJapan
- Study dates
- 7 Jun 2023to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- No data on information on the start and end dates or continuation of treatment with Venetoclax.
- Participating in other clinical trials.
Trial locations and contacts
1 site in 1 country.
Japan1 site
National Cancer Center Hospital East /ID# 265970
Kashiwa-shi, Chiba, 277-8577
About this study
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
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.
Read more
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
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Chronic Lymphocytic Leukemia (CLL) Participants | Participants will receive treatments for CLL in accordance with approved local label. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants with Undetectable Minimal Residual Disease (uMRD)
UMRD is defined as <10^-4 in peripheral blood (PB) assessed by flow cytometry (FCM).
Measured: Up to 27 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2024
- Study start7 Jun 2023
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lymphocytic LeukemiaStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06362044
- Sponsor's protocol ID
- P24-120
- Status last verified
- Nov 2025
- First submitted
- 9 Apr 2024
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06362044
- Acronym / sponsor ID
- P24-120
- Conditions
- Chronic Lymphocytic Leukemia
- Keywords
- Chronic Lymphocytic Leukemia, CLL, Venetoclax, Rituximab, ABT-199
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 7 Jun 2023 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 12 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic Lymphocytic Leukemia (CLL) Participants | – | –Participants will receive treatments for CLL in accordance with approved local label. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- No data on information on the start and end dates or continuation of treatment with Venetoclax.
- Participating in other clinical trials.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
- Individual participant dataSharing planned: Undecided
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Nemtabrutinib for Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Leukemia (SLL) Refractory to Covalent Bruton Tyrosine Kinase Inhibitor or Pirtobrutinib and Previously Treated With a BCL2 Inhibitor
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RecruitingObservational study
Natural History Study of Monoclonal B Cell Lymphocytosis (MBL), Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL), Lymphoplasmacytic Lymphoma (LPL)/Waldenstrom Macroglobulinemia (WM), and Splenic Marginal Zone Lymphoma (SMZL)
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RecruitingPhase 3
A Study of Nemtabrutinib Plus Venetoclax vs Venetoclax + Rituximab (VR) in Second-line (2L) + Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) (MK-1026-010/BELLWAVE-010).
Leukemia, Lymphocytic, Chronic, B-Cell, Leukemia, Chronic Lymphocytic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ABBVIE INC. study director
AbbVie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Lymphocytic Leukemia, run by AbbVie at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants with Undetectable Minimal Residual Disease (uMRD) (time frame: Up to 27 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2025.