Ibrutinib and Venetoclax for Chronic Lymphocytic Leukemia in Real-World Care

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study follows patients treated with fixed-duration Ibrutinib plus Venetoclax (I+V) in routine clinical practice to see how effective the regimen is outside of a controlled trial. Participants must have CLL or SLL requiring treatment per iwCLL 2018 guidelines and have started I+V before joining the study, with data collected from medical records and patient-reported outcomes. The study relies on consent and real-world data sources to assess treatment outcomes and PROs in diverse clinical settings. No experimental interventions are performed by the researchers beyond standard care, and there is no randomization. Results will help understand how I+V performs in everyday clinical use.

Why it matters

Who can join: the full rules

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

Where it's running

• Spitalul Universitar de Urgenta Bucuresti
  Bucharest, Romania Recruiting

Study contacts

• Study coordinator: Study Contact
• Email: Participate-In-This-Study1@its.jnj.com
• Phone: 844-434-4210

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.