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

NCT05963074
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Phase
Phase 2
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Recruitment status
Active, not recruiting
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Participants
333
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Lead sponsor
Janssen Research & Development, LLC
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Start date
2024-05-30
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Number of sites
74
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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).
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Acronym
TAILOR
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Short title
A Study to Customize Ibrutinib Treatment Regimens for Participants With Previously Untreated Chronic Lymphocytic Leukemia
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Official title
Multicohort Study to Customize Ibrutinib Treatment Regimens for Patients With Previously Untreated Chronic Lymphocytic Leukemia
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Active, not recruiting
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Phase
Phase 2
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Study type
Interventional
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Completion date
2029-03-19
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First posted
2023-07-27
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Registry last updated
2026-08-28
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Primary completion date
2027-12-15
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Start date
2024-05-30
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Actual participants
333
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Participants
333
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Participant count basis
Actual
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Protocol amendments
3
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Number of sites
74
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Janssen Research & Development, LLC
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Source registry
ClinicalTrials.gov
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Registry ID
NCT05963074
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ClinicalTrials.gov ID
NCT05963074
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

  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.

  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
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • 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)

  • 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
clinicaltrials.gov

  • 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
clinicaltrials.gov

  • 2023
  • 2023-504044-34-00
  • 54179060CLL2032
Sources for references
clinicaltrials.gov

Related records

Drugs (2)

Collaborators (1)

Lead sponsors (1)

Targets (2)