Leukemia, Lymphocytic, Chronic, B-CellREALITY-RONCT07602088
A Real-world Study of Ibrutinib and Venetoclax (I+V) First-Line Treatment Given for Fixed-duration of Time in Participants With Chronic Lymphocytic Leukemia
An observational study of Leukemia, Lymphocytic, Chronic, B-Cell, run by Janssen Research & Development, LLC at 1 site in Romania.
Trial summary
The purpose of this study is to see how well Ibrutinib and Venetoclax (I+V) treatment works (effectiveness) for participants with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) when it is used in routine, everyday medical care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia, Lymphocytic, Chronic, B-Cell
- How many people
- 60 participants
- Where
- 1 siteRomania
- Study dates
- 18 May 2026to 30 Nov 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: The study will include adult participants with a confirmed diagnosis of Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) requiring first-line treatment, per international workshop on chronic lymphocytic leukemia (iwCLL) 2018 criteria or at the discretion of the treating physician using I+V treatment in routine clinical practice.
Who may be able to join
- Has a confirmed diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) requiring treatment according to international workshop on chronic lymphocytic leukemia (iwCLL) 2018 guidelines
- Intented for the treatment with fixed-duration ibrutinib plus venetoclax treatment (I+V) according to the approved indication. Decision to start I+V treatment must have been taken before and independently of participant's inclusion in the study
- Participant must sign an informed consent form (ICF) allowing source data verification in accordance with local requirements
- Is able to read, understand, and complete the PRO instruments in local language and comply with completion of all patient-reported outcome (PRO) instruments
Who cannot join
- Has a history of CLL/SLL treatment
- Has received an investigational medicinal product (including investigational vaccines) or used an invasive investigational medical device within 30 days before the start of the study or the first data collection time point
- Is currently enrolled or plans to participate in an interventional clinical study (participation in a non-Janssen sponsored non-interventional study or registry is allowed)
- Falls under any restrictions or limitations preventing treatment with I+V as per the current approved label of ibrutinib or venetoclax in Romania
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Romania1 site, 1 recruiting
- Recruiting
Spitalul Universitar de Urgenta Bucuresti
Bucharest, 050098
About this study
Official title: Prospective Cohort Study With Fixed-Duration Ibrutinib + Venetoclax (I+V) First-Line Treatment in Patients With Chronic Lymphocytic Leukemia in a Real-World Setting
The purpose of this study is to see how well Ibrutinib and Venetoclax (I+V) treatment works (effectiveness) for participants with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) when it is used in routine, everyday medical care.
- Conditions
- Leukemia, Lymphocytic, Chronic, B-Cell
- 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)/Small Lymphocytic Lymphoma (SLL) Participants | Participants with a confirmed diagnosis of CLL/SLL requiring first-line treatment, per international workshop on chronic lymphocytic leukemia (iwCLL) 2018 or at the discretion of the treating physician using ibrutinib plus venetoclax treatment in routine clinical practice will be enrolled in this study. No drug will be administered and only data available within routine clinical practice will be collected in this study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (ORR)
The ORR is defined as the percentage of participants achieving the best response of complete or partial response (including complete response [CR], complete response with incomplete hematological recovery [CRi], partial response [PR] or partial response with lymphocytosis [PR-L]).
Measured: Up to approximately Week 60
Secondary outcomes (15)
Number of Participants with Factors Affecting the Physician Treatment Decision Using the Physician's Treatment Decision Questionnaire
Participants with factors affecting the physicians treatment decision using the physician's treatment decision questionnaire (European Organization for Research and Treatment of Cancer [EORTC] Quality of Life Questionnaire]) will be reported.
Measured: At baseline
Number of Participants with Factors Affecting Participant's Decision to Accept or Continue with the Proposed Treatment Using the Physician's Treatment Decision Questionnaire
Participants with factors affecting the participant's decision to accept or continue with the proposed treatment using the physician's treatment decision questionnaire (EORTC Quality of Life Questionnaire) will be reported.
Measured: At baseline
Overall Response Rate (ORR) By the End of Treatment Cycles
ORR is defined as the percentage of participants achieving the best response of complete or partial response (including CR, CRi, PR or PR-L).
Measured: Up to approximately Week 48
Duration of response (DoR)
DoR is defined as time (in months ) from the first date of achieving complete or partial response (including CR, CRi, PR, or PR-L) to the date of first documented evidence of progressive disease (PD) or death.
Measured: Up to approximately Week 60
Progression-free survival (PFS)
PFS is measured from the start of I+V treatment to documented disease progression, relapse, or death due to any cause.
Measured: Up to approximately 4 years
Overall survival (OS)
OS is measured from the start of I+V treatment to date of death due to any cause.
Measured: Up to approximately 4 years
Time on treatment (TOT)
TOT is defined as time from the start of I+V treatment to the time of the end of treatment.
Measured: Up to approximately Week 60
Time to Treatment Discontinuation (TTD)
TTD is defined as the time from the start of I+V treatment to the premature discontinuation of ibrutinib or venetoclax (whichever is earlier).
Measured: Up to approximately Week 60
Time to Next Treatment (TTNT)
TTNT is measured from the start of I+V treatment to the start of subsequent chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) treatment where applicable.
Measured: Up to approximately Week 60
Change from Baseline in Health-Related Quality of Life as Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Chronic lymphocytic leukemia 17 (EORTC QLQ-CLL17)
The EORTC QLQ-CLL17, comprising 17 questions, was developed to supplement the core questionnaire and to specifically assess the health status of participants with CLL. It comprises 17 items grouped into 3 multi-item scales: 1) symptom burden, 2) physical condition/fatigue, and 3) worries/fears about health and functioning. Each question is rated using a 4-point response scale ("not at all," "a little," "quite a bit," and "very much"). The scores of each subscale are calculated and then transformed to a 0 to 100 scale. Higher scores represent higher levels of symptom burden, physical condition/fatigue, or worries/fears about health and functioning.
Measured: From Baseline up to approximately 4 years
Number of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs) and Special Situations
An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. An SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above. Number of participants with AEs, all serious AEs, and all special situations (for example, medication error, overdosing, abuse, lack of effect, unexpected benefits following exposure to ibrutinib etc.) will be reported.
Measured: Up to approximately 4 years
Number of Participants with Tumor Lysis Risk
Number of participants with tumor lysis risk (absolute lymphocyte count [ALC] and lymph node diameter) will be reported. Tumor lysis will be categorized as: 1) high: any lymph node with largest diameter greater than or equal to (>=) 10 centimeter (cm) or any lymph node with largest diameter >=5 cm and ALC >=25 gram/liter (G/L); 2) intermediate: any lymph node >=5 cm to less than (<) 10 cm or ALC >=25 G/L; and 3) low: all lymph nodes <5 cm and ALC <25 G/L.
Measured: At Baseline and After 12 Weeks
Number of Participants with Hospitalization for Venetoclax Ramp-up For The I+V Treatment
Participants with hospitalization for venetoclax ramp-up for The I+V treatment will be reported.
Measured: Up to approximately 4 years
Duration of Hospitalization
Duration of hospitalization is defined as number of days from the day of admission to discharge.
Measured: Up to approximately 4 years
Number of Emergency Room Visits
Emergency room visits, other than due to a serious adverse event following exposure to ibrutinib will be reported.
Measured: Up to approximately 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start18 May 2026
- Primary completion30 Jan 2029 (estimated)
- Study completion30 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leukemia, Lymphocytic, Chronic, B-CellStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07602088
- Sponsor's protocol ID
- 54179060CLL4039
- Acronym
- REALITY-RO
- Status last verified
- Nov 2026
- First submitted
- 16 May 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- Yes: The data sharing policy of Johnson \& Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Cohort Study With Fixed-Duration Ibrutinib + Venetoclax (I+V) First-Line Treatment in Patients With Chronic Lymphocytic Leukemia in a Real-World Setting
- ClinicalTrials.gov ID
- NCT07602088
- Acronym / sponsor ID
- REALITY-RO / 54179060CLL4039
- Conditions
- Leukemia, Lymphocytic, Chronic, B-Cell
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 18 May 2026 (actual)
- Primary completion
- 30 Jan 2029 (estimated)
- Study completion
- 30 Nov 2029 (estimated)
- First posted
- 22 May 2026 (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.
The purpose of this study is to see how well Ibrutinib and Venetoclax (I+V) treatment works (effectiveness) for participants with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) when it is used in routine, everyday medical care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) Participants | – | –Participants with a confirmed diagnosis of CLL/SLL requiring first-line treatment, per international workshop on chronic lymphocytic leukemia (iwCLL) 2018 or at the discretion of the treating physician using ibrutinib plus venetoclax treatment in routine clinical practice will be enrolled in this study. No drug will be administered and only data available within routine clinical practice will be collected in this study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will include adult participants with a confirmed diagnosis of Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) requiring first-line treatment, per international workshop on chronic lymphocytic leukemia (iwCLL) 2018 criteria or at the discretion of the treating physician using I+V treatment in routine clinical practice.
Key inclusion criteria (4 listed)
- Has a confirmed diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) requiring treatment according to international workshop on chronic lymphocytic leukemia (iwCLL) 2018 guidelines
- Intented for the treatment with fixed-duration ibrutinib plus venetoclax treatment (I+V) according to the approved indication. Decision to start I+V treatment must have been taken before and independently of participant's inclusion in the study
- Participant must sign an informed consent form (ICF) allowing source data verification in accordance with local requirements
- Is able to read, understand, and complete the PRO instruments in local language and comply with completion of all patient-reported outcome (PRO) instruments
Key exclusion criteria (4 listed)
- Has a history of CLL/SLL treatment
- Has received an investigational medicinal product (including investigational vaccines) or used an invasive investigational medical device within 30 days before the start of the study or the first data collection time point
- Is currently enrolled or plans to participate in an interventional clinical study (participation in a non-Janssen sponsored non-interventional study or registry is allowed)
- Falls under any restrictions or limitations preventing treatment with I+V as per the current approved label of ibrutinib or venetoclax in Romania
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
Overall Response Rate (ORR)
Time frame: Up to approximately Week 60
The ORR is defined as the percentage of participants achieving the best response of complete or partial response (including complete response [CR], complete response with incomplete hematological recovery [CRi], partial response [PR] or partial response with lymphocytosis [PR-L]).
15 secondary outcomes
Number of Participants with Factors Affecting the Physician Treatment Decision Using the Physician's Treatment Decision Questionnaire
Time frame: At baseline
Number of Participants with Factors Affecting Participant's Decision to Accept or Continue with the Proposed Treatment Using the Physician's Treatment Decision Questionnaire
Time frame: At baseline
Overall Response Rate (ORR) By the End of Treatment Cycles
Time frame: Up to approximately Week 48
Duration of response (DoR)
Time frame: Up to approximately Week 60
Progression-free survival (PFS)
Time frame: Up to approximately 4 years
Overall survival (OS)
Time frame: Up to approximately 4 years
Time on treatment (TOT)
Time frame: Up to approximately Week 60
Time to Treatment Discontinuation (TTD)
Time frame: Up to approximately Week 60
Time to Next Treatment (TTNT)
Time frame: Up to approximately Week 60
Change from Baseline in Health-Related Quality of Life as Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Chronic lymphocytic leukemia 17 (EORTC QLQ-CLL17)
Time frame: From Baseline up to approximately 4 years
Number of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs) and Special Situations
Time frame: Up to approximately 4 years
Number of Participants with Tumor Lysis Risk
Time frame: At Baseline and After 12 Weeks
Number of Participants with Hospitalization for Venetoclax Ramp-up For The I+V Treatment
Time frame: Up to approximately 4 years
Duration of Hospitalization
Time frame: Up to approximately 4 years
Number of Emergency Room Visits
Time frame: Up to approximately 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: Yes. The data sharing policy of Johnson \& Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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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.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
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 Leukemia, Lymphocytic, Chronic, B-Cell, run by Janssen Research & Development, LLC at 1 site in Romania.
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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 3 Nov 2026. 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 Romania. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Contact (844-434-4210, Participate-In-This-Study1@its.jnj.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate (ORR) (time frame: Up to approximately Week 60). 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 3 Nov 2026.