An observational study in Leukemia, Lymphocytic, Chronic, B-Cell, sponsored by Janssen Research & Development, LLC. Recruiting at 1 site in Romania. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Janssen Research & Development, LLC (part of Johnson & Johnson) · Observational
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Among 26 studies in Leukemia, Lymphocytic, Chronic, B-Cell by Johnson & Johnson — 3 open to participants now, 7 under way, 2 of them phase 3. Leukemia, Lymphocytic, Chronic, B-Cell · Johnson & Johnson.
Among the 26 studies in Leukemia, Lymphocytic, Chronic, B-Cell by Johnson & Johnson, this one is the only one that started in 2026, is one of 7 observational ones, and was the 26th registered.
2,036 studies on the registry are indexed under Leukemia, Lymphocytic, Chronic, B-Cell; 237 are open to participants now.
Browse Leukemia, Lymphocytic, Chronic, B-Cell studies →3 of the 26 studies in Leukemia, Lymphocytic, Chronic, B-Cell by Johnson & Johnson are open now, in 12 countries. Recruiting first, the newest first:
Janssen Cilag S.A.S. · Sites in France
Ages 18+
Janssen Research & Development, LLC · Sites in Australia, Belgium, Denmark and 12 more countries
Ages 18+
By country, each count listing its studies:
Of the 188 Leukemia, Lymphocytic, Chronic, B-Cell studies recruiting now, 150 (80%) set no upper age limit and 15 (8%) stop at 75 or younger; 17 take children under 18; 13 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
26 studies; the count open now beside each. This study's row is marked.
First in 1990; this study’s year is marked. 1 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 60 is below the median of 146 across 215 observational studies indexed under Leukemia, Lymphocytic, Chronic, B-Cell.
Median enrollment 134 across the 18 interventional studies, 180 across the 7 observational. Of the 16 that completed or were terminated, 3 (19%) have results posted.
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This study is registered under Janssen Research & Development, LLC, one of the names counted as Johnson & Johnson. Under that name alone:
Janssen Research & Development, LLC is the lead sponsor of 932 studies on the registry; 76 are open to participants now.
Of its 285 completed or terminated interventional studies of FDA-regulated products, 136 (48%) have results posted.
1 of the studies in Leukemia, Lymphocytic, Chronic, B-Cell by Johnson & Johnson that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT01804686Phase 3Janssen Research & Development, LLCA Long-term Extension Study of PCI-32765 (Ibrutinib) | 2026-12-31 |
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Among the 26 studies in Leukemia, Lymphocytic, Chronic, B-Cell by Johnson & Johnson, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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 \[PR-L\]).
Time frame: Up to approximately Week 60
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.
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
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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
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)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to approximately 4 years
Duration of Hospitalization
Duration of hospitalization is defined as number of days from the day of admission to discharge.
Time frame: 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.
Time frame: Up to approximately 4 years
Plan to share: 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
Data sharing details ↗ · www.jnj.com
No publications or documents are linked to this record.
Started May 2026 (actual). Primary completion is estimated for Jan 2029, 32 months after the start.
Of 34 industry-sponsored observational studies under Leukemia, Lymphocytic, Chronic, B-Cell, half reached primary completion within 54 months of starting (the median), counting those still running; a quarter within 35 and three quarters within 66. This study's planned 32 months is below that.
Counting every sponsor, half of 104 studies reached it within 60 months; a quarter within 32 and three quarters within 176.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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