The purpose of this study is to investigate the efficacy and safety of fixed-duration sonrotoclax (also known as BGB-11417) plus zanubrutinib (also known as BGB-3111) (SZ) compared with fixed-duration of venetoclax plus acalabrutinib (AV) in participants with previously untreated chronic lymphocytic leukemia (CLL).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
500
Administered orally.
Administered orally.
Administered orally.
Administered orally.
Concord Repatriation General Hospital
Concord, New South Wales, Australia
RECRUITINGGenesiscare North Shore
St Leonards, New South Wales, Australia
RECRUITINGPrincess Alexandra Hospital
Woolloongabba, Queensland, Australia
RECRUITINGMonash Health
Clayton, Victoria, Australia
RECRUITINGCabrini Hospital Malvern
Malvern East, Victoria, Australia
RECRUITINGThe Alfred Hospital
Melbourne, Victoria, Australia
RECRUITINGCentro Gaucho Integrado de Oncologia Hospital Mae de Deus
Porto Alegre, Brazil
RECRUITINGInstituto Dor de Pesquisa E Ensino Sao Paulo
São Paulo, Brazil
RECRUITINGCiusss Nim Hscm
Montreal, Quebec, Canada
RECRUITINGJewish General Hospital
Montreal, Quebec, Canada
RECRUITING...and 10 more locations
Progression-Free Survival (PFS) as Determined by Independent Review Committee (IRC)
PFS is defined as the time from the date of randomization to the date of disease progression as determined by IRC or death due to any cause, whichever occurs first.
Time frame: Up to approximately 70 months
Rate of Undetectable Minimal Residual Disease at < 10^-4 sensitivity (uMRD4)
Rate of uMRD4 is defined as the percentage of participants that achieved uMRD4 measured in both peripheral blood (PB) and bone marrow aspirate (BMA) at the post-treatment follow-up visit (PTFU1) based on next generation sequencing (NGS).
Time frame: Up to approximately 16 months
PFS in High-Risk Participants
PFS is defined as the time from the date of randomization to the date of disease progression as determined by IRC or death due to any cause, whichever occurs first.
Time frame: Up to approximately 70 months
Overall Survival (OS)
OS is defined as the time from the date of randomization to the date of death due to any cause.
Time frame: Up to approximately 70 months
Overall Response Rate (ORR) as Determined by IRC
ORR is defined as the percentage of participants with a complete response (CR), complete response with incomplete hematopoietic recovery (CRi), nodal partial response (nPR), or partial response (PR), before disease progression, death, or the start of new anti-CLL treatment (whichever is earlier), as assessed by IRC.
Time frame: Up to approximately 70 months
Rate of Undetectable Minimal Residual Disease at < 10^-5 sensitivity (uMRD5)
Rate of uMRD5 is defined as the percentage of participants who achieved uMRD5 measured in both PB and BMA at the PTFU1 Visit based on NGS, before disease progression, death, or the start of new anti-CLL treatment (whichever is earlier).
Time frame: Up to approximately 16 months
Number of Participants with Adverse Events
Number of participants with treatment-emergent adverse events (TEAEs), adverse events of clinical interest, and serious adverse events (SAEs), including laboratory values, vital signs, and physical examination findings.
Time frame: Up to approximately 70 months
PFS Determined by Investigator Assessment
PFS is defined as the time from the date of randomization to the date of disease progression as determined by investigator or death due to any cause, whichever occurs first.
Time frame: Up to approximately 70 months
Complete Response Rate (CRR) by IRC and Investigator Assessment
CRR is defined as the percentage of participants with a CR or CRi before disease progression, death, or the start of new anti-CLL treatment (whichever is earlier).
Time frame: Up to approximately 70 months
ORR Determined by Investigator Assessment
ORR is defined as the percentage of participants with a complete response or partial response, before disease progression, death, or the start of new anti-CLL treatment (whichever is earlier), as assessed by investigator.
Time frame: Up to approximately 70 months
Duration of Response (DOR)
Duration of response (determined by both IRC and investigator assessment) is defined as the time from the first qualifying response (CR, CRi, nPR, or PR) until CLL progression or death. DOR analysis will only include responders.
Time frame: Up to approximately 70 months
Time to Next Treatment (TTNT)
TTNT is defined as the time from randomization to the start of the next treatment for CLL.
Time frame: Up to approximately 70 months
Change from Baseline in Score on European Organization for Research and Treatment of Cancer (EORTC) Item Library (IL)-409 Questionnaire
Patient-reported symptoms of global health status (GHS), role functioning, and physical functioning, symptom burden and physical condition/fatigue will be measured using the European Organization for Research and Treatment of Cancer quality of life questionnaire EORTC IL-409 (an itemized version of \[EORTC\] quality of life questionnaire core 30 \[QLQ-C30\] and its CLL module CLL17). The EORTC-IL-409 consists of 17 questions answered on a 4-point scale where 1 = Not at all (best) to 4 = Very Much (worst) and 2 global health questions answered on a 7-point scale where 1 = Very poor (worst) to 7 = Excellent (best). Higher scores in GHS and functional scales and lower scores in symptom scales indicate better quality of life.
Time frame: At baseline and up to approximately 70 months
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