An observational study in Leukemia, Lymphocytic, Chronic, B-Cell, sponsored by Janssen Cilag S.A.S.. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Janssen Cilag S.A.S. (part of Johnson & Johnson) · Observational
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
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 one of 3 that started in 2024, is one of 7 observational ones, and was the 24th 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 Research & Development, LLC · Sites in Romania
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. 3 started in 2024.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 180 is above 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.
This tab as a report to print or save as PDF → With an account.
This study is registered under Janssen Cilag S.A.S., one of the names counted as Johnson & Johnson. Under that name alone:
Janssen Cilag S.A.S. is the lead sponsor of 8 studies on the registry; 2 are open to participants now.
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 |
Add it to your calendar (.ics) → With an account.
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 assess the impact of an individual physical activity intervention (IPAI) on health-related quality of life (HRQoL) in participants with first line or relapsed chronic lymphocytic leukemia (CLL) initiating ibrutinib in a routine clinical practice setting. HRQoL will be measured using functional assessment of cancer therapy - general scale (FACT-G).
The study population will include participants aged at least 18 years of age with chronic lymphocytic leukemia (CLL).
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.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
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.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
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 chronic lymphocytic leukemia (CLL) will be invited to perform physical activity according to a predefined intervention program. This program includes walking and weekly remote adapted physical activity sessions (2 sessions per week, the duration and difficulty of which will be adapted by the adapted physical activity \[APA\] trainer according to the Participant's abilities).
Behavioral: Individual Physical Activity Intervention (IPAI) · Drug: Ibrutinib
Participants with CLL will continue physical activity according to their lifestyle and the recommendations of the medical team.
Drug: Ibrutinib
No drug will be administered as a part of this study. The intervention will consist in an IPAI provided to participants for 6 months to practice physical activity in addition to their medical treatment in routine clinical practice settings. IPAI will be an adaptive program and will comprise two periods, the first period consisting in a supervised 4-month program and the second one in an unsupervised 2-month program to achieve greater autonomy.
No drug will be administered as a part of this study. Participants received ibrutinib as per their routine clinical practice settings.
Change from Baseline in Health-related Quality of Life (HRQoL) by Using Functional Assessment of Cancer Therapy General (FACT-G) Total Score at Month 4.5
The FACT-G consists of 27 questions grouped in 4 dimensions: physical well-being (PWB; 7 items), social/family well-being (SWB; 7 items), emotional well-being (EWB; 6 items), and functional well-being (FWB; 7 items). Each item is given a weighted score of 0 to 4 and the score of each dimension are obtained by addition of the weighted scores of each item corresponding to the dimension. Total FACT-G score is the summation of 4 subscale scores and ranges from 0-108. Higher scores for the scales and subscales indicate better HRQoL.
Time frame: Baseline and Month 4.5
Change from Baseline in HRQoL by Using Functional Assessment of Cancer Therapy - Leukemia (FACT-Leu) Total Score at Month 4.5, Month 6.5 and Month 12
The FACT-Leu questionnaire consists of 44 questions grouped into 5 dimensions: PWB (7 items), SWB (7 items), EWB (6 items), FWB (7 items) and additional concerns (LEUS; 17 items). Each item is given a weighted score of 0 to 4 and the score of each dimension are obtained by addition of the weighted scores of each item corresponding to the dimension. Total FACT-Leu score is the summation of 5 subscale scores and ranges from 0-176. Higher scores for the scales and subscales indicate better HRQoL.
Time frame: Baseline, Month 4.5, Month 6.5, and Month 12
Change from Month 4.5 in HRQoL by Using FACT-Leu Total Score at Month 6.5
The FACT-Leu questionnaire consists of 44 questions grouped into 5 dimensions: PWB (7 items), SWB (7 items), EWB (6 items), FWB (7 items) and additional concerns (LEUS; 17 items). Each item is given a weighted score of 0 to 4 and the score of each dimension are obtained by addition of the weighted scores of each item corresponding to the dimension. Total FACT-Leu score is the summation of 5 subscale scores and ranges from 0-176. Higher scores for the scales and subscales indicate better HRQoL.
Time frame: Month 4.5 and Month 6.5
Change from Month 6.5 in HRQoL by Using FACT-Leu Total Score at Month 12
The FACT-Leu questionnaire consists of 44 questions grouped into 5 dimensions: PWB (7 items), SWB (7 items), EWB (6 items), FWB (7 items) and additional concerns (LEUS; 17 items). Each item is given a weighted score of 0 to 4 and the score of each dimension are obtained by addition of the weighted scores of each item corresponding to the dimension. Total FACT-Leu score is the summation of 5 subscale scores and ranges from 0-176. Higher scores for the scales and subscales indicate better HRQoL.
Time frame: Month 6.5 and Month 12
Change from Baseline in HRQoL by Using Trial Outcome Index (TOI) Total Score at Month 4.5, Month 6.5, and Month 12
The TOI questionnaire consists of 31 questions grouped into 5 dimensions: PWB (7 items), FWB (7 items) and additional concerns (LEUS; 17 items). Each item is given a weighted score of 0 to 4 and the score of each dimension are obtained by addition of the weighted scores of each item corresponding to the dimension. Total TOI score is the summation of 5 subscale scores and ranges from 0-176. Higher scores for the scales and subscales indicate better HRQoL.
Time frame: Baseline, Month 4.5, Month 6.5, and Month 12
Change from Month 4.5 in HRQoL by Using Trial Outcome Index (TOI) Total Score at Month 6.5
The TOI questionnaire consists of 31 questions grouped into 5 dimensions: PWB (7 items), FWB (7 items) and additional concerns (LEUS; 17 items). Each item is given a weighted score of 0 to 4 and the score of each dimension are obtained by addition of the weighted scores of each item corresponding to the dimension. Total TOI score is the summation of 5 subscale scores and ranges from 0-176. Higher scores for the scales and subscales indicate better HRQoL.
Time frame: Month 4.5 and Month 6.5
Change from Month 6.5 in HRQoL by Using Trial Outcome Index (TOI) Total Score at Month 12
The TOI questionnaire consists of 31 questions grouped into 5 dimensions: PWB (7 items), FWB (7 items) and additional concerns (LEUS; 17 items). Each item is given a weighted score of 0 to 4 and the score of each dimension are obtained by addition of the weighted scores of each item corresponding to the dimension. Total TOI score is the summation of 5 subscale scores and ranges from 0-176. Higher scores for the scales and subscales indicate better HRQoL.
Time frame: Month 6.5 and Month 12
Change from Baseline in HRQoL by Using FACT-G Scale at Month 6.5 and Month 12
The FACT-G consists of 27 questions grouped in 4 dimensions: physical well-being (PWB; 7 items), social/family well-being (SWB; 7 items), emotional well-being (EWB; 6 items), and functional well-being (FWB; 7 items). Each item is given a weighted score of 0 to 4 and the score of each dimension are obtained by addition of the weighted scores of each item corresponding to the dimension. Total FACT-G score is the summation of 4 subscale scores and ranges from 0-108. Higher scores for the scales and subscales indicate better HRQoL.
Time frame: Baseline, Month 6.5, and Month 12
Change from Month 4.5 in HRQoL by Using FACT-G Scale at Month 6.5
The FACT-G consists of 27 questions grouped in 4 dimensions: physical well-being (PWB; 7 items), social/family well-being (SWB; 7 items), emotional well-being (EWB; 6 items), and functional well-being (FWB; 7 items). Each item is given a weighted score of 0 to 4 and the score of each dimension are obtained by addition of the weighted scores of each item corresponding to the dimension. Total FACT-G score is the summation of 4 subscale scores and ranges from 0-108. Higher scores for the scales and subscales indicate better HRQoL.
Time frame: Month 4.5 and Month 6.5
Change from Month 6.5 in HRQoL by Using FACT-G Scale at Month 12
The FACT-G consists of 27 questions grouped in 4 dimensions: physical well-being (PWB; 7 items), social/family well-being (SWB; 7 items), emotional well-being (EWB; 6 items), and functional well-being (FWB; 7 items). Each item is given a weighted score of 0 to 4 and the score of each dimension are obtained by addition of the weighted scores of each item corresponding to the dimension. Total FACT-G score is the summation of 4 subscale scores and ranges from 0-108. Higher scores for the scales and subscales indicate better HRQoL.
Time frame: Month 6.5 and Month 12
Percentage of Participants Achieving a Greater Than or Equal to (>=) 5-Point Improvement in the FACT-G Total Score at Months 4.5, 6.5, and 12 as Compared to Baseline
The FACT-G consists of 27 questions grouped in 4 dimensions: physical well-being (PWB; 7 items), social/family well-being (SWB; 7 items), emotional well-being (EWB; 6 items), and functional well-being (FWB; 7 items). Each item is given a weighted score of 0 to 4 and the score of each dimension are obtained by addition of the weighted scores of each item corresponding to the dimension. Total FACT-G score is the summation of 4 subscale scores and ranges from 0-108. Higher scores for the scales and subscales indicate better HRQoL.
Time frame: Baseline, Month 4.5, Month 6.5, and Month 12
Change from Baseline in the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Total Score at Month 4.5, Month 6.5, and Month 12
The FACIT-fatigue is a questionnaire that assesses self-reported tiredness, weakness, and difficulty conducting usual activities due to fatigue. The subscale consists of 13-item instrument to measure fatigue. Each of the 13 items has a set of five response categories: Not at all (=0), A little bit (=1), Somewhat (=2), Quite a bit (=3) and Very much (=4). A total FACIT-Fatigue subscale score is calculated as the sum of the 13 item scores (reserved scores \[4 - score\]) and ranges from 0 to 52, with a higher score indicating less fatigue. Positive changes from baseline indicate improvement of fatigue. Items are reverse scored when appropriate to provide a scale in which higher scores represent better functioning or less fatigue.
Time frame: Baseline, Month 4.5, Month 6.5, and Month 12
Change From Baseline in Total Sleep Time Using Connected Watch
Change from baseline in total sleep time (in hours) using connected watch will be assessed.
Time frame: Baseline, Month 4.5, Month 6.5, and Month 12
Change From Baseline in Total Sleep Score Using Connected Watch
Change from baseline in total sleep score (time asleep/time in bed) based on duration, regularity, depth and interruption using connected watch will be assessed.
Time frame: Baseline, Month 4.5, Month 6.5, and Month 12
Change From Baseline in Sleep Stages Using Connected Watch
Change from baseline in sleep stages (deep/light) using connected watch will be assessed.
Time frame: Baseline, Month 4.5, Month 6.5, and Month 12
Change From Baseline in Hospital Anxiety and Depression (HAD) Score at Month 4.5, Month 6.5, and Month 12
The HAD scale is a 14-items measure that assesses anxiety and depressive disorders. The scale includes seven questions related to anxiety (total A) and seven others to the depressive dimension (total D). Each item is rated from 0 to 3. Two scores are derived from the scale, one related to anxiety and the other related to depression (maximum score for each score = 21). Higher scores indicate increased anxiety or depression.
Time frame: Baseline, Month 4.5, Month 6.5, and Month 12
Change From Baseline in Physical Fitness as Measured by Six-Minute Walk Test (6MWT) at Month 4.5, Month 6.5, and Month 12
The 6MWT is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. It is easy to administer, better tolerated, and more reflective of activities of daily living than the other walk tests.
Time frame: Baseline, Month 4.5, Month 6.5, and Month 12
Change From Baseline in Physical Activity as Assessed by Number of Steps per Day Using Connected Watch
Change from baseline in physical activity as assessed by number of steps per day using connected watch will be reported.
Time frame: Baseline, Month 4.5, Month 6.5, and Month 12
Change From Baseline in Physical Activity as Assessed by the Number of Walking Sessions per Week using Connected Watch
Change from baseline in physical activity as assessed by the number of walking sessions per week using connected watch will be reported.
Time frame: Baseline, Month 4.5, Month 6.5, and Month 12
Change From Baseline in Physical Activity as Assessed by the Time of Walking Sessions per Week Using Connected Watch
Change from baseline in physical activity as assessed by the time of walking sessions per week using connected watch will be reported.
Time frame: Baseline, Month 4.5, Month 6.5, and Month 12
Change From Baseline in Physical Activity as Assessed by the Distance of Walking Sessions per Week Using Connected Watch
Change from baseline in physical activity as assessed by the distance of walking sessions per week using connected watch will be reported.
Time frame: Baseline, Month 4.5, Month 6.5, and Month 12
Percentage of Participants with Treatment-related Adverse Events
Percentage of participants with treatment-related adverse events especially musculoskeletal and cardiovascular treatment-related adverse events will be reported.
Time frame: Up to 30 months
Time to Treatment Discontinuation (TTD)
TTD is defined as the time between the first day of ibrutinib treatment and the day that ibrutinib is definitely stopped for whatever reason or death.
Time frame: Months 6 and 12
Reasons for Treatment Discontinuation
Number of participants in each reason for treatment discontinuation will be reported. Reasons for treatment discontinuation are defined as: adverse events, lack of efficacy, patient's convenience, physician's decision, progression, death or other.
Time frame: Up to Month 12
Percentage of Participants Who Still Wear the Connected Watch
Percentage of participants who still wear the connected watch (adherence) will be assessed.
Time frame: Months 1, 3, 4.5, 6.5, and 12
Percentage of Participants Retained by the Connected Watch (Start Wearing the Watch)
Percentage of participants retained by the connected watch (start wearing the watch) will be assessed.
Time frame: Months 1, 3, 4.5, 6.5, and 12
Percentage of Participants Agreed to Participate in the Study Among Eligible participants with Chronic Lymphocytic Leukemia (CLL) Initiation Ibrutinib Treatment
Percentage of participants agreed to participate in the study among eligible participants with CLL initiation ibrutinib treatment will be reported.
Time frame: During the first 6 months (Feasibility period)
For Group 1: Percentage of Participants Who Still Follow the Individual Physical Activity Intervention (IPAI) Among Those Who Have Started IPAI
Percentage of participants who still follow the IPAI among those who have started IPAI (Adherence) in group 1 will be assessed.
Time frame: Months 1, 3, 4.5, and 6.5
For Group 1: Percentage of Participants Who Follow the Adapted Physical Activity (APA) Sessions, the Walking Objectives and the APA Appointment as Scheduled With the APA Among Those Who Have Started IPAI
Percentage of participants who follow the adapted physical activity sessions, the walking objectives and the APA appointment as scheduled with the APA among those who have started IPAI (Compliance) in group 1 will be assessed.
Time frame: Months 1, 3, 4.5, and 4.6
For Group 1: Percentage of Participants Retained by the IPAI (First APA Videoconference Attended) Among Participants Enrolled in the Study
Percentage of participants retained by the IPAI (first APA videoconference attended) among participants enrolled in the study will be assessed.
Time frame: Months 1 and 3
For Group 1: Percentage of Participants who Completed the Supervised Period Among Participants Enrolled in the Study
Percentage of participants who completed the supervised period among participants enrolled in the study will be assessed.
Time frame: Month 4.5
For Group 1: Percentage of Participants who Completed the Unsupervised Period Among Participants Enrolled in the Study
Percentage of participants who completed the unsupervised period among participants enrolled in the study will be assessed.
Time frame: Month 6.5
For Group 1: Participant Satisfaction With the IPAI Measured With the Satisfaction Likert Scale
Participant's' satisfaction will be assessed by Likert scales at Months 4.5 and 6.5 regarding coaching, proposed sessions, program content, program duration, impact on APA practice, overall satisfaction, willingness to continue and recommendation to others. Likert scales will assess participant's' satisfaction at Month 12 regarding impact on APA practice, overall satisfaction, willingness to continue and recommendation to others. Only one question is quantitative with score range from 0 (not at all satisfied) to 10 (totally satisfied) for global satisfaction. Participants are considered satisfied when score is greater than or equal to (\>=) 6 and highly-satisfied when score is \>=8. All other questions are qualitative and have 5-level Likert scales including: very satisfied, rather satisfied, neither satisfied nor dissatisfied, not really satisfied, not at all satisfied.
Time frame: Months 4.5, 6.5, and 12
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 ↗ · innovativemedicine.jnj.com
No publications or documents are linked to this record.
Started May 2024 (actual). Primary completion is estimated for Oct 2026, 29 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 29 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.
Primary completion moved once since we started tracking on Sep 25, 2026: Sep 2026 → Oct 2026, on Nov 3, 2026.
Completion moved once since we started tracking on Sep 25, 2026: Oct 2027 → Nov 2027, on Sep 25, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
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 ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Leukemia, Lymphocytic, Chronic, B-Cell →