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

NCT07602088 | Recruiting

• 1 other identifier: 54179060CLL4039
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Outcome Measures

Primary Outcomes (1)

• 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 \[PR-L\]).

  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

  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

  At baseline

• Overall Response Rate (ORR) By the End of Treatment Cycles

  Up to approximately Week 48

• Duration of response (DoR)

  Up to approximately Week 60

• Progression-free survival (PFS)

  Up to approximately 4 years

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (1)

Spitalul Universitar de Urgenta Bucuresti

Bucharest, 050098, Romania

RECRUITING

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Central Study Contacts

Study Contact

CONTACT

844-434-4210; Participate-In-This-Study1@its.jnj.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2026
• First Posted: May 22, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): January 30, 2029
• Study Completion (Estimated): November 30, 2029
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

RO (1)