This study is designed to evaluate progression-free survival (PFS) endpoint for acalabrutinib versus (vs) ibrutinib in previously treated chronic lymphocytic leukemia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
533
Participants will receive oral acalabrutinib as stated in arm description.
Participants will receive oral ibrutinib as stated in arm description.
Progression-free Survival (PFS) Based on Independent Review Committee (IRC) Assessment
The PFS is defined as the time from date of randomization to the date of first IRC-assessed PD or death due to any cause, whichever occurred first. PD (per International Workshop on Chronic Lymphocytic Leukemia \[iwCLL\] 2008 criteria): Lymphocytes \>= 50% increase over baseline, or \>= 50% increase in lymphadenopathy/hepatomegaly/splenomegaly, or \>= 50% platelets or \> 2 g/dL hemoglobin decreases from baseline secondary to chronic lymphocytic leukemia (CLL). The PFS is assessed using the Kaplan-Meier method.
Time frame: Baseline (Days -28 to -1) through 55.2 months (maximum observed duration)
Number of Participants With Treatment-emergent Infections Grade >= 3
Number of participants with treatment-emergent infections Grade \>=3 are reported.
Time frame: Day 1 through 83.5 months (maximum observed duration)
Number of Participants With Treatment-emergent Richter's Transformation
Richter's transformation is defined as the occurrence of an aggressive lymphoma in participants with a previous or concomitant diagnosis of CLL. Richter's transformation was assessed by central pathology. Number of participants with treatment-emergent Richter's transformation are reported.
Time frame: Day 1 through 83.5 months (maximum observed duration)
Number of Participants With Treatment-emergent Atrial Fibrillation
Number of participants with treatment-emergent atrial fibrillation (including atrial flutter) are reported.
Time frame: Day 1 through 83.5 months (maximum observed duration)
Overall Survival (OS)
The OS is defined as the time from date of randomization to date of death due to any cause. The OS is assessed using the Kaplan-Meier method.
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Research Site
Phoenix, Arizona, United States
Research Site
Anaheim, California, United States
Research Site
Berkeley, California, United States
Research Site
Duarte, California, United States
Research Site
La Jolla, California, United States
Research Site
Los Angeles, California, United States
Research Site
Palo Alto, California, United States
Research Site
Santa Rosa, California, United States
Research Site
Jacksonville, Florida, United States
Research Site
Tampa, Florida, United States
...and 120 more locations
Time frame: Baseline (Days -28 to -1) through 83.7 months (maximum observed duration)
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.
Time frame: Day 1 through 83.5 months (maximum observed duration)
Number of Participants With Treatment-emergent Laboratory Abnormalities
Number of participants with treatment-emergent laboratory abnormalities are reported. Laboratory abnormality is defined as any abnormal finding during analysis of hematology and serum chemistry.
Time frame: Day 1 through 83.5 months (maximum observed duration)
Number of Participants With Abnormal Vital Signs Reported as TEAEs
Number of participants with abnormal vital signs reported as TEAEs are reported. Abnormal vital signs are defined as any abnormal finding in the vital sign parameters (body temperature, blood pressure, heart rate, and respiratory rate).
Time frame: Day 1 through 83.5 months (maximum observed duration)
Percentage of Participants With Lymphocytosis
Percentage of participants with at least one occurrence of treatment-related lymphocytosis defined as an elevation in ALC of \>= 50% compared with baseline and a postbaseline assessment of \> 5000/μL in the peripheral blood are reported.
Time frame: Day 1 through 83.5 months (maximum observed duration)
Number of Participants With Electrocardiogram (ECG) Abnormality at Baseline
Number of participants with ECG abnormality at baseline are reported.
Time frame: Baseline (Days -28 to -1)
Number of Participants With Shift From Baseline to Worst (Grade 3 and 4) Postbaseline in Eastern Cooperative Oncology Group (ECOG) Performance Status
The ECOG performance status assessed participant's performance status on 5 point scale: 0=Fully active/able to carry on all pre-disease activities without restriction; 1=restricted in physically strenuous activity, ambulatory/able to carry out light or sedentary work; 2=ambulatory (\>50% of waking hours), capable of all self-care, unable to carry out any work activities; 3=capable of only limited self care, confined to bed/chair \>50% of waking hrs; 4=completely disabled, cannot carry on any self care, totally confined to bed/chair; 5=death. Number of participants with shift from baseline (Days -28 to -1) to worst Grade 3 and 4 in ECOG performance status are reported.
Time frame: Baseline (Days -28 to -1) through 83.5 months (maximum observed duration)