Ibrutinib Plus Venetoclax Long-Term Outcomes in CLL

NCT07774390 | Recruiting

• 1 other identifier: I+V-LT
• Study Type: observational
• Target: 323
• Locations: 1 country
• Sites: 1

Brief Summary

This study is focused on tracking the long-term health of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) treated with a combination of two drugs, ibrutinib and venetoclax, as part of the original CAPTIVATE clinical trial. Purpose and Goals While new treatments have significantly improved survival for patients with CLL, the disease remains incurable and often requires multiple rounds of treatment over a person's life. The primary goal of this study is to understand what happens to patients after they have completed their initial (frontline) treatment with a combination of two drugs, ibrutinib and venetoclax, as part of the original CAPTIVATE clinical trial. Researchers specifically want to:

• Identify the types and frequency of "second-line" treatments patients receive if their disease returns.
• Assess the long-term safety and effectiveness of the initial ibrutinib and venetoclax treatment.
• Study how the disease might become resistant to these treatments over time. Who Can Participate? The study is specifically for individuals who were previously enrolled in the original CAPTIVATE study. Only patients at participating medical centers who provide their informed consent can join. Study Methods and Procedures This is an observational study, meaning researchers will monitor patients' health during their routine medical care rather than testing a new, experimental treatment. Key aspects of the study include:
• Long-Term Monitoring: Patients will be followed for up to 10 years.
• Data Collection: Researchers will collect information on disease status, treatment history, new health issues (comorbidities), and survival.
• Optional Testing: With additional consent, patients may provide blood samples every six months to check for "measurable residual disease" (MRD)-very small amounts of cancer cells that remain after treatment.
• Genetic Analysis: If a patient's CLL progresses, researchers may analyze blood samples to look for specific genetic mutations that might explain why the treatment stopped working. Participation is entirely voluntary, and patients can choose to withdraw from the study or opt out of specific tests (like blood sampling) at any time without affecting their standard medical care.

Conditions

Chronic Lymphocytic Leukemia (CLL); Small Lymphocytic Lymphoma (SLL)

Keywords

ibrutinib; venetoclax; CLL; SLL

Outcome Measures

Primary Outcomes (1)

• Type and frequency of second line treatments

  Type and frequency of second line treatments (including re-treatment with ibrutinib or ibrutinib + venetoclax) of patients with CLL treated with the combination of frontline ibrutinib plus venetoclax in the CAPTIVATE study.

  Assessed annually after baseline up to 10 years

Secondary Outcomes (14)

• Duration of response

  Assessed annually after baseline up to 10 years

• Complete response rate

  Assessed annually after baseline up to 10 years

• Overall response rate

  Assessed annually after baseline up to 10 years

• Richter transformation rate

  Assessed annually after baseline up to 10 years

• Adverse events

  Assessed annually after baseline up to 10 years

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Only patients enrolled in the CAPTIVATE study will be enrolled in this study.

You may qualify if:

• Participant is willing and able to give informed consent for participation in this study.
• Previously enrolled into the CAPTIVATE study.
• Being treated in a center that has agreed to participate in this follow-up study.

You may not qualify if:

• \. Inability or refusal to provide informed consent.

Sponsors & Collaborators

• Pharmacyclics LLC.: collaborator
• European Research Initiative on CLL: lead

Study Sites (1)

IRCCS Ospedale San Raffaele

Milan, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Samples will be collected, optionally only for patients enrolled in Spain and Italy.

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

Central Study Contacts

Paolo Ghia, Prof

CONTACT

+39 02 26433919; ghia.paolo@hsr.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2026
• First Posted: August 19, 2026
• Study Start: December 18, 2025
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): November 20, 2034
• Last Updated: August 19, 2026

Record last verified: 2026-08

Locations

IT (1)