Sonrotoclax
DrugAdministered orally.
Other names: BGB-11417
NCT Number: NCT07277231
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).
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 3
Blacktown Cancer and Haematology Centre, Blacktown, New South Wales, Australia
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Administered orally.
Other names: BGB-11417
Administered orally.
Other names: BGB-3111, Brukinsa
Administered orally.
Other names: Calquence
Administered orally.
Other names: Venclexta, Venclyxto
Time frame: Up to approximately 70 months
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 16 months
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 70 months
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
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
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 16 months
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 70 months
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 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
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 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 (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
TTNT is defined as the time from randomization to the start of the next treatment for CLL.
Time frame: At baseline and up to approximately 70 months
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.
Contact information is provided by the study sponsor or research team.
BeOne Medicines
Industry
A Phase 3, Open-Label, Randomized Study of Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Acalabrutinib in Patients With Previously Untreated Chronic Lymphocytic Leukemia
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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