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

Small Lymphocytic Lymphoma Clinical Trial

— TAILOR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05963074
• Other study ID #: 54179060CLL2032
• Secondary ID: 2023-504044-34-0
• Status: Recruiting
• Phase: Phase 2
• Start date: January 31, 2024
• Est. completion date: March 19, 2029

Study information

• Verified date: April 2024
• Source: Janssen Research & Development, LLC
• Contact: Study Contact
• Phone: 844-434-4210
• Email: Participate-In-This-Study[@]its.jnj.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 320
• Est. completion date: March 19, 2029
• Est. primary completion date: September 29, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid
• Small Lymphocytic Lymphoma

Intervention

Drug:
• Ibrutinib
Ibrutinib capsules will be administered orally.
• Venetoclax
Venetoclax tablets will be administered orally.

Locations

Country	Name	City	State
Spain	Hosp. Univ. Marques de Valdecilla	Santander
United States	The Oncology Institute Clinical Research	Cerritos	California
United States	Oncology Hematology Care	Cincinnati	Ohio
United States	Willamette Valley Cancer Institute and Research Center	Eugene	Oregon
United States	Hunterdon Hematology Oncology	Flemington	New Jersey
United States	Texas Oncology-Fort Worth Cancer Center	Fort Worth	Texas
United States	Virginia Cancer Specialists	Gainesville	Virginia
United States	Southeastern Medical Oncology Center	Goldsboro	North Carolina
United States	Grand Valley Oncology	Grand Junction	Colorado
United States	Hope and Healing Cancer Services	Hinsdale	Illinois
United States	Iowa City VA Health Care System	Iowa City	Iowa
United States	Research Medical Center	Kansas City	Missouri
United States	Mount Sinai Medical Center Campus	Miami Beach	Florida
United States	Minnesota Oncology Hematology, P.A.	Minneapolis	Minnesota
United States	Community Cancer Trials of Utah	Ogden	Utah
United States	Providence Medical Foundation	Santa Rosa	California
United States	VA Puget Sound Healthcare System	Seattle	Washington
United States	Springfield Clinic	Springfield	Illinois
United States	Texas Oncology-Gulf Coast	The Woodlands	Texas
United States	Northwest Cancer Specialists PC	Vancouver	Washington
United States	Virginia Oncology Associates	Virginia Beach	Virginia
United States	PIH Health Hospital	Whittier	California

Sponsors (2)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC	Pharmacyclics LLC.

Countries where clinical trial is conducted

United States,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Best Overall Response Rate (ORR)	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.	Up to 5 years
Secondary	Complete Response (CR) Rate	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.	Up to 5 years
Secondary	Duration of Response (DOR)	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.	Up to 5 years
Secondary	Progression Free Survival (PFS)	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.	Up to 5 years
Secondary	Overall Survival (OS)	OS is defined as the time from date of randomization to date of death from any cause.	Up to 5 years
Secondary	Cohorts 1a and 1b: Minimal Residual Disease (MRD) Negative Rate	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.	Up to 5 years
Secondary	Number of Participants with Adverse Events (AEs)	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.	Up to 5 years
Secondary	Number of Participants with AEs by Severity	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.	Up to 5 years
Secondary	Percentage of Participants with Rate of Discontinuation due to AEs	Percentage of participants with rate of discontinuation due to AEs will be reported.	Up to 5 years
Secondary	Percentage of Participants with Dose Reduction due AEs	Percentage of participants with dose reduction due AEs will be reported.	Up to 5 years
Secondary	Adherence Rates	The adherence rate is defined as the percentage of total dose taken over the total dose prescribed.	Up to 5 years
Secondary	Duration of Treatment	Duration of treatment is defined as the time period in days between the date of first study treatment administration and date of last administration.	Up to 5 years
Secondary	Time to Worsening as Measured by EuroQol 5 Dimension 5 Level Questionnaire (EQ-5D-5L)	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.	Up to 5 years
Secondary	Time to Worsening as Measured by European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire (EORTC QLQ)-C30)	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.	Up to 5 years
Secondary	Time to Worsening as Measured by EORTC QLQ-CLL17	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.	Up to 5 years
Secondary	Time to Worsening as Measured by Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Total Score	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.	Up to 5 years