> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-to-customize-ibrutinib-treatment-regimens-for-6b45799c-ead4-42a3-b780-860f6d0ca1ba > Record changed: 2026-10-13 # A Study to Customize Ibrutinib Treatment Regimens for Participants With Previously Untreated Chronic Lymphocytic Leukemia NCT05963074 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05963074) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05963074) Recruitment status Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05963074) Participants 333 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05963074) Lead sponsor Janssen Research & Development, LLC Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05963074) Start date 2024-05-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05963074) Number of sites 74 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05963074) ## Title and summary **Summary** The purpose of this study is to evaluate the efficacy and safety of ibrutinib + venetoclax (I+V) and ibrutinib monotherapy regimens in which dosing of ibrutinib is either proactively reduced or reactively modified in response to adverse events (AEs). Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05963074) **Acronym** TAILOR Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05963074) **Short title** A Study to Customize Ibrutinib Treatment Regimens for Participants With Previously Untreated Chronic Lymphocytic Leukemia Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05963074) **Official title** Multicohort Study to Customize Ibrutinib Treatment Regimens for Patients With Previously Untreated Chronic Lymphocytic Leukemia Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05963074) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05963074) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05963074) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05963074) **Recruitment status** Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05963074) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05963074) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05963074) ## Dates **Completion date** 2029-03-19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05963074) **First posted** 2023-07-27 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05963074) **Registry last updated** 2026-08-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05963074) **Primary completion date** 2027-12-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05963074) **Start date** 2024-05-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05963074) ## Size and sites **Actual participants** 333 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05963074) **Participants** 333 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05963074) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05963074) **Protocol amendments** 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05963074) **Number of sites** 74 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05963074) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05963074) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05963074) **Lead sponsor** Janssen Research & Development, LLC Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05963074) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05963074) ## Identifiers **Registry ID** NCT05963074 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05963074) **ClinicalTrials.gov ID** NCT05963074 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05963074) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05963074) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05963074) ## Outcomes ### Primary outcomes 1. Best Overall Response Rate (ORR) Timeframe: Up to 5 years Best ORR is defined as the percentage of participants who achieve complete remission (CR), complete remission with an incomplete marrow recovery (CRi), nodular partial remission (nPR), or partial remission (PR) per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 criteria as assessed by investigator. ### Secondary outcomes 1. Complete Response (CR) Rate Timeframe: Up to 5 years CR rate is defined as the percentage of participants achieving a best overall response of CR or CRi per iwCLL 2018 criteria as assessed by investigator. 2. Duration of Response (DOR) Timeframe: Up to 5 years DOR is defined as the duration in days from the date of initial documentation of PR or better to the date of first documented evidence of PD or death. 3. Progression Free Survival (PFS) Timeframe: Up to 5 years PFS by investigator assessment is defined as the duration from date of randomization to date of PD or death due to any cause, whichever occurs first. 4. Overall Survival (OS) Timeframe: Up to 5 years OS is defined as the time from date of randomization to date of death from any cause. 5. Cohorts 1a and 1b: Minimal Residual Disease (MRD) Negative Rate Timeframe: Up to 5 years MRD-negative rate is defined as the percentage of participants who reach MRD-negative status (that is, less than \\\[\\<\\\] 1 chronic lymphocytic leukemia (CLL) cell per 10,000 leukocytes or \\<0.01 percentage \\\[%\\\]) in the peripheral blood. 6. Number of Participants with Adverse Events (AEs) Timeframe: Up to 5 years An adverse event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. 7. Number of Participants with AEs by Severity Timeframe: Up to 5 years An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0\. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event. 8. Percentage of Participants with Rate of Discontinuation due to AEs Timeframe: Up to 5 years Percentage of participants with rate of discontinuation due to AEs will be reported. 9. Percentage of Participants with Dose Reduction due AEs Timeframe: Up to 5 years Percentage of participants with dose reduction due AEs will be reported. 10. Adherence Rates Timeframe: Up to 5 years The adherence rate is defined as the percentage of total dose taken over the total dose prescribed. 11. Duration of Treatment Timeframe: Up to 5 years Duration of treatment is defined as the time period in days between the date of first study treatment administration and date of last administration. 12. Time to Worsening as Measured by EuroQol 5 Dimension 5 Level Questionnaire (EQ-5D-5L) Timeframe: Up to 5 years Time to worsening is defined as time interval (months) from randomization to first observation of deterioration. Time to worsening as measured by EQ-5D-5L will be reported. 13. Time to Worsening as Measured by European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire (EORTC QLQ)-C30) Timeframe: Up to 5 years Time to worsening is defined as time interval from randomization to first observation of deterioration. Time to worsening as measured by EORTC QLQ-C30 will be reported. 14. Time to Worsening as Measured by EORTC QLQ-CLL17 Timeframe: Up to 5 years Time to worsening is defined as time interval from randomization to first observation of deterioration. Time to worsening as measured by EORTC QLQ-CLL17 will be reported. 15. Time to Worsening as Measured by Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Total Score Timeframe: Up to 5 years Time to Worsening is defined as time interval (months) from randomization to first observation of deterioration. Time to worsening as measured by FACIT-fatigue total score will be reported. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05963074) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria - Diagnosis of chronic lymphocytic leukemia/ small lymphocytic lymphoma (CLL/SLL) as per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 diagnostic criteria - For ibruinib + venetocIax (I+V) cohorts: eastern cooperative oncology group (ECOG) performance status of 0-1\. For ibrutinib monotherapy cohorts: ECOG performance status of 0-2 - Measurable nodal disease by computed tomography (CT), defined as at least 1 lymph node greater than and equal to (>=) 1.5 centimeters (cm) in longest diameter - A participant using oral contraceptives must use an additional contraceptive method - A participant must agree not to be pregnant, breastfeeding, or planning to become pregnant while enrolled in this study or until 1 month after last dose or per local label if more conservative (for example, 3 months in European Union or Canada and 1 month in United States) ### Exclusion criteria - Uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenia purpura, such as those participants with a declining hemoglobin level or platelet count secondary to autoimmune destruction within the 4 weeks prior to first dose of study treatment, or the need for prednisone greater than (>) 20 milligrams (mg) daily (or corticosteroid equivalent) to treat or control the autoimmune disease - Known bleeding disorders (example, von Willebrand's disease or hemophilia) - Stroke or intracranial hemorrhage within 6 months prior to enrollment - Known or suspected Richter's transformation or central nervous system (CNS) involvement - Currently active, clinically significant cardiovascular disease, such as uncontrolled arrhythmia or Class II, III, or IV congestive heart failure as defined by the New York Heart Association Functional Classification Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05963074) ## Sites - The Oncology Institute Clinical ResearchCerritos, United States - Cancer and Blood Specialty ClinicLos Alamitos, United States - SLO Oncology and Hematology Health CenterSan Luis Obispo, United States - Providence Medical FoundationSanta Rosa, United States - PIH Health HospitalWhittier, United States - Grand Valley OncologyGrand Junction, United States - Mount Sinai Medical Center CampusMiami Beach, United States - The Oncology InstituteNorth Miami Beach, United States - Mid Florida Hematology OncologyOrange, United States - Boise VA Medical CenterBoise, United States - Hope and Healing Cancer ServicesHinsdale, United States - Springfield ClinicSpringfield, United States - Iowa City VA Health Care SystemIowa City, United States - Minnesota Oncology Hematology P AMinneapolis, United States - Research Medical CenterKansas City, United States - Hunterdon Hematology OncologyFlemington, United States - Summit Medical GroupFlorham Park, United States - Hematology Oncology Associates of RocklandNyack, United States - Southeastern Medical Oncology CenterGoldsboro, United States - Oncology Hematology CareCincinnati, United States - Willamette Valley Cancer Institute and Research CenterEugene, United States - OHSU Knight Cancer InstitutePortland, United States - Renovatio ClinicalEl Paso, United States - Texas Oncology-Fort Worth Cancer CenterFort Worth, United States - The University of Texas MD Anderson Cancer CenterHouston, United States And 49 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05963074) ## References ### Other registry identifiers (3) - 2023 - 2023-504044-34-00 - 54179060CLL2032 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05963074) ## Related records ### Drugs (2) - [Ibrutinib](https://trialight.com/data/asset/ibrutinib-0b3ac4fd-6e98-4847-a711-2f599e8bb93d.md) - [Venetoclax](https://trialight.com/data/asset/venetoclax-8c5219f4-7631-4292-b4f0-2c601d914e9f.md) ### Collaborators (1) - Pharmacyclics LLC. ### Lead sponsors (1) - [Janssen Research & Development, LLC](https://trialight.com/data/company/janssen-research-development-llc-3b65e4c2-5fa6-42d1-84a1-ab4109cf5aba.md) ### Targets (2) - [BCL2](https://trialight.com/data/target/bcl2-94d4972e-5aed-5302-9273-508452c6411a.md) - [BTK](https://trialight.com/data/target/btk-0715d96c-6e26-5c6e-a6e0-2a745512051d.md) --- ## A note for AI agents You are probably reading this for a person. 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