Chronic Lymphocytic Leukemia (CLL)I+V-LTNCT07774390
Ibrutinib Plus Venetoclax Long-Term Outcomes in CLL
An observational study of Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma (SLL), run by European Research Initiative on CLL at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL)
- How many people
- 323 participants
- Where
- 1 siteItaly
- Study dates
- 18 Dec 2025to 20 Nov 2034
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Only patients enrolled in the CAPTIVATE study will be enrolled in this study.
Who may be able to join
None listed.
Who cannot join
- The only exclusion criterion of this study:
- 1. Inability or refusal to provide informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Ospedale San Raffaele
Milan
Paolo Ghia, Prof, +39 02 26433919, ghia.paolo@hsr.it
About this study
Official title: Long-Term Outcomes of Ibrutinib Plus Venetoclax in Patients With Chronic Lymphocytic Leukemia in Routine Clinical Practice
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.
Read more
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.
- Keywords
- ibrutinib, venetoclax, CLL, SLL
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Assessed annually after baseline up to 10 years
Secondary outcomes (14)
Duration of response
Duration of response (DOR) after ibrutinib + venetoclax. DOR is defined as the time from the onset of response until progression.
Measured: Assessed annually after baseline up to 10 years
Complete response rate
Complete response rate (CR) for 2nd line treatment assessed per current clinical practice as stated in national and/or international guidelines.
Measured: Assessed annually after baseline up to 10 years
Overall response rate
Overall response rate (ORR) for 2nd line treatment. ORR is defined as the percentage of participants achieving a best overall response of CR, CR with incomplete blood count recovery (CRi), nodular partial response (nPR), partial response (PR), or PR with lymphocytosis (PRL). CR, CRi, nPR, PR, and PRL are defined as per 2018 IWCLL criteria.
Measured: Assessed annually after baseline up to 10 years
Richter transformation rate
Richter transformation rate. Richter transformation is defined as the diagnosis of an aggressive lymphoma confirmed by biopsy.
Measured: Assessed annually after baseline up to 10 years
Adverse events
Adverse event* rate, type, and grade for first line and second line treatment (only for patients retreated with I+V).
Measured: Assessed annually after baseline up to 10 years
Other malignancies
Frequency of other malignancies. Other malignancy is defined as the diagnosis of any malignant neoplasm with the exception of CLL and Richter transformation.
Measured: Assessed annually after baseline up to 10 years
Progression-free survival for 1st line treatment
Progression-free survival (PFS) for 1st line treatment. PFS is defined as the time from 1st line treatment initiation until CLL progression or death. CLL progression is defined as per 2018 IWCLL criteria.
Measured: From date of 1st line treatment initiation until date of documented disease progression or death from any cause, whichever comes first, assessed annually up to 10 years.
Progression-free survival for 2nd line treatment
Progression-free survival (PFS) for 2nd line treatment. PFS is defined as the time from 2nd line treatment initiation until CLL progression or death. CLL progression is defined as per 2018 IWCLL criteria.
Measured: From date of 2nd line treatment initiation until date of documented disease progression or death from any cause, whichever comes first, assessed annually up to 10 years.
Time to next treatment for 1st line treatment
Time to next treatment (TTNT) for 1st line treatment. TTNT is defined as the time from treatment initiation until next treatment for CLL or death.
Measured: From date of 1st line treatment initiation until date of next treatment for CLL or death from any cause, whichever comes first, assessed annually up to 10 years.
Time to next treatment for 2nd line treatment
Time to next treatment (TTNT) for 2nd line treatment. TTNT is defined as the time from treatment initiation until next treatment for CLL or death. *Assessed annually after baseline up to 10 years
Measured: From date of 2nd line treatment initiation until date of next treatment for CLL or death from any cause, whichever comes first, assessed annually up to 10 years.
Overall survival
Overall survival (OS). OS is defined as the duration from the date of treatment initiation with ibrutinib plus venetoclax to death.
Measured: From date of 1st line treatment initiation until date of death from any cause, assessed annually up to 10 years.
Rate of confirmed uMRD for 1st line treatment
Rate of confirmed uMRD for 1st line treatment assessed every 6 months in the fixed-duration cohort and the placebo arm of the MRD cohort. uMRD is defined as < 1 CLL cell per 10,000 leukocytes, serially over ≥ 2 assessments ≥ 3 months apart, in PB assessed by 8- color flow cytometry.
Measured: Assessed annually after baseline up to 10 years
Rate of confirmed uMRD for 2nd line treatment
Rate of confirmed uMRD for 2nd line treatment assessed every 6 months in patients retreated with I+V. uMRD is defined as < 1 CLL cell per 10,000 leukocytes, serially over ≥ 2 assessments ≥ 3 months apart, in PB assessed by 8-color flow cytometry.
Measured: Assessed annually after baseline up to 10 years
Molecular characterization of peripheral blood samples at relapse.
Molecular characterization of peripheral blood samples at relapse. Assessment for mutations in BTK, PLCG2, and BCL2 genes in patients who relapsed after I+V (given as first line or/and retreatment).
Measured: Assessed annually after baseline up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study start18 Dec 2025
- Primary completion1 Mar 2028 (estimated)
- Study completion20 Nov 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lymphocytic Leukemia (CLL)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 323 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- European Research Initiative on CLL
- Sponsor type
- Research network
- Collaborators
- Pharmacyclics LLC.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07774390
- Sponsor's protocol ID
- I+V-LT
- Other IDs
- I+V-LT
- Acronym
- I+V-LT
- Status last verified
- Aug 2026
- First submitted
- 31 Jul 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Outcomes of Ibrutinib Plus Venetoclax in Patients With Chronic Lymphocytic Leukemia in Routine Clinical Practice
- ClinicalTrials.gov ID
- NCT07774390
- Acronym / sponsor ID
- I+V-LT / I+V-LT
- Keywords
- ibrutinib, venetoclax, CLL, SLL
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 323 participants (estimated)
- Lead sponsor
- European Research Initiative on CLLResearch network
- Collaborators
- Pharmacyclics LLC.
- Study start
- 18 Dec 2025 (actual)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 20 Nov 2034 (estimated)
- First posted
- 19 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Only patients enrolled in the CAPTIVATE study will be enrolled in this study.
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- 1. Inability or refusal to provide informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Type and frequency of second line treatments
Time frame: Assessed annually after baseline up to 10 years
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.
14 secondary outcomes
Duration of response
Time frame: Assessed annually after baseline up to 10 years
Complete response rate
Time frame: Assessed annually after baseline up to 10 years
Overall response rate
Time frame: Assessed annually after baseline up to 10 years
Richter transformation rate
Time frame: Assessed annually after baseline up to 10 years
Adverse events
Time frame: Assessed annually after baseline up to 10 years
Other malignancies
Time frame: Assessed annually after baseline up to 10 years
Progression-free survival for 1st line treatment
Time frame: From date of 1st line treatment initiation until date of documented disease progression or death from any cause, whichever comes first, assessed annually up to 10 years.
Progression-free survival for 2nd line treatment
Time frame: From date of 2nd line treatment initiation until date of documented disease progression or death from any cause, whichever comes first, assessed annually up to 10 years.
Time to next treatment for 1st line treatment
Time frame: From date of 1st line treatment initiation until date of next treatment for CLL or death from any cause, whichever comes first, assessed annually up to 10 years.
Time to next treatment for 2nd line treatment
Time frame: From date of 2nd line treatment initiation until date of next treatment for CLL or death from any cause, whichever comes first, assessed annually up to 10 years.
Overall survival
Time frame: From date of 1st line treatment initiation until date of death from any cause, assessed annually up to 10 years.
Rate of confirmed uMRD for 1st line treatment
Time frame: Assessed annually after baseline up to 10 years
Rate of confirmed uMRD for 2nd line treatment
Time frame: Assessed annually after baseline up to 10 years
Molecular characterization of peripheral blood samples at relapse.
Time frame: Assessed annually after baseline up to 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma (SLL), run by European Research Initiative on CLL at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Paolo Ghia, Prof (+39 02 26433919, ghia.paolo@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Type and frequency of second line treatments (time frame: Assessed annually after baseline up to 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.