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NCT Number: NCT05963074

A Study to Customize Ibrutinib Treatment Regimens for Participants With Previously Untreated Chronic Lymphocytic Leukemia

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).

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

QEII Health Sciences Centre, Halifax, Nova Scotia, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ibrutinib

Drug

Ibrutinib capsules will be administered orally.

Other names: JNJ-54179060, IMBRUVICA

Venetoclax

Drug

Venetoclax tablets will be administered orally.

Other names: VENCLEXTA, VENCLYXTO

Primary outcomes

  1. Best Overall Response Rate (ORR)

    Time frame: 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

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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

    Time frame: 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)

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: Up to 5 years

    Percentage of participants with dose reduction due AEs will be reported.

  10. Adherence Rates

    Time frame: 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

    Time frame: 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)

    Time frame: 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)

    Time frame: 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

    Time frame: 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

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Study Contact

CONTACT

[email protected]

844-434-4210

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Collaborators

  • Pharmacyclics LLC.

Registry information

Official study title

Multicohort Study to Customize Ibrutinib Treatment Regimens for Patients With Previously Untreated Chronic Lymphocytic Leukemia

Acronym: TAILOR

Important dates

Study start
2024
Primary completion
2027
Study completion
2029
First posted
Jul 27, 2023
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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