NCT07602088 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
| NCT ID | NCT07602088 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Janssen Research & Development, LLC |
| Condition | Leukemia, Lymphocytic, Chronic, B-Cell |
| Study Type | OBSERVATIONAL |
| Enrollment | 60 participants |
| Start Date | 2026-05-18 |
| Primary Completion | 2029-01-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 60 participants in total. It began in 2026-05-18 with a primary completion date of 2029-01-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria * 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 Exclusion Criteria * 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
Contact & Investigator
Janssen Research & Development, LLC Clinical Trial
STUDY DIRECTOR
Janssen Research & Development, LLC
Frequently Asked Questions
Who can join the NCT07602088 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Leukemia, Lymphocytic, Chronic, B-Cell. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07602088 currently recruiting?
Yes, NCT07602088 is actively recruiting participants. Contact the research team at Participate-In-This-Study1@its.jnj.com for enrollment information.
Where is the NCT07602088 trial being conducted?
This trial is being conducted at Bucharest, Romania.
Who is sponsoring the NCT07602088 clinical trial?
NCT07602088 is sponsored by Janssen Research & Development, LLC. The principal investigator is Janssen Research & Development, LLC Clinical Trial at Janssen Research & Development, LLC. The trial plans to enroll 60 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.