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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
333
Ibrutinib capsules will be administered orally.
Venetoclax tablets will be administered orally.
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.
Time frame: Up to 5 years
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.
Time frame: Up to 5 years
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.
Time frame: Up to 5 years
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.
Time frame: Up to 5 years
Overall Survival (OS)
OS is defined as the time from date of randomization to date of death from any cause.
Time frame: Up to 5 years
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.
Time frame: Up to 5 years
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The Oncology Institute Clinical Research
Cerritos, California, United States
Cancer and Blood Specialty Clinic
Los Alamitos, California, United States
SLO Oncology and Hematology Health Center
San Luis Obispo, California, United States
Providence Medical Foundation
Santa Rosa, California, United States
PIH Health Hospital
Whittier, California, United States
Grand Valley Oncology
Grand Junction, Colorado, United States
Mount Sinai Medical Center Campus
Miami Beach, Florida, United States
The Oncology Institute
North Miami Beach, Florida, United States
Mid Florida Hematology Oncology
Orange, Florida, United States
Boise VA Medical Center
Boise, Idaho, United States
...and 64 more locations
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.
Time frame: Up to 5 years
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.
Time frame: Up to 5 years
Percentage of Participants with Rate of Discontinuation due to AEs
Percentage of participants with rate of discontinuation due to AEs will be reported.
Time frame: Up to 5 years
Percentage of Participants with Dose Reduction due AEs
Percentage of participants with dose reduction due AEs will be reported.
Time frame: Up to 5 years
Adherence Rates
The adherence rate is defined as the percentage of total dose taken over the total dose prescribed.
Time frame: Up to 5 years
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.
Time frame: Up to 5 years
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.
Time frame: Up to 5 years
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.
Time frame: Up to 5 years
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.
Time frame: Up to 5 years
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.
Time frame: Up to 5 years