Sonrotoclax
DrugAdministered orally
Other names: BGB-11417
NCT Number: NCT06943872
The goal of this study is to compare how well sonrotoclax plus obinutuzumab works versus venetoclax plus rituximab in treating adults with relapsed and/or refractory (R/R) chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). The study will also compare how well sonrotoclax plus rituximab works versus venetoclax plus rituxumab in treating adults with R/R CLL/SLL. The safety of these treatments will also be assessed.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 3
Hospital Aleman, CABA, Argentina
Our company, previously known as BeiGene, is now officially BeOne Medicines. Because some of our older studies were sponsored under the name BeiGene, you may see both names used for this study on this website.
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 intravenously
Other names: Gazyva
Administered intravenously
Other names: Rituxan
Administered Orally
Other names: Venclexta
Time frame: Up to approximately 51 months
PFS is defined as the time from randomization to the date of progression or death, whichever occurs first.
Time frame: Up to approximately 69 months
PFS is defined as the time from randomization to the date of progression or death, whichever occurs first.
Time frame: Up to approximately 12 months
The rate of undetectable minimal residual disease (uMRD4) in peripheral blood based on next-generation sequencing (NGS)
Time frame: Up to approximately 25 months
Complete Response Rate (CRR) is defined as the percentage of participants that achieve a best response of complete response (CR) or complete response with incomplete hematopoietic recovery (CRi)
Time frame: Up to approximately 84 months
Overall survival (OS) is defined as the time from the date of randomization to the date of death
Time frame: Up to approximately 69 months
PFS is defined as the time from randomization to the date of progression or death, whichever occurs first.
Time frame: Up to approximately 25 months
CRR is defined as the percentage of participants that achieve a best response of CR or CRi
Time frame: Up to approximately 84 months
OS is defined as the time from the date of randomization to the date of death
Time frame: Up to approximately 25 months
The rate of uMRD4 in peripheral blood based on NGS
Time frame: Up to approximately 69 months
PFS is defined as the time from randomization to the date of progression or death, whichever occurs first.
Time frame: Up to approximately 25 months
CRR is defined as the percentage of participants that achieve a best response of CR or CRi
Time frame: Up to approximately 84 months
OS is defined as the time from the date of randomization to the date of death
Time frame: Up to approximately 25 months
The rate of uMRD4 in peripheral blood based on NGS
Time frame: Up to approximately 25 months
The rate of uMRD4 in peripheral blood based on NGS
Time frame: Up to approximately 25 months
CRR is defined as the percentage of participants that achieve a best response of CR or CRi
Time frame: Up to approximately 51 months
PFS is defined as the time from randomization to the date of progression or death, whichever occurs first.
Time frame: Up to approximately 69 months
PFS is defined as the time from randomization to the date of progression or death, whichever occurs first.
Time frame: Up to approximately 25 months
CRR is defined as the percentage of participants that achieve a best response of CR or CRi
Time frame: Up to approximately 84 months
OS is defined as the time from the date of randomization to the date of death
Time frame: Up to approximately 25 months
The rate of uMRD4 in peripheral blood based on NGS
Time frame: Up to approximately 25 months
ORR is defined as the percentage of participants that achieve a best response of partial response (PR) or better
Time frame: Up to approximately 69 months
DOR is defined as the time from the date that response criteria were first met to the date of first documentation of disease progression or death, whichever occurs first
Time frame: Up to approximately 25 months
TTR is defined as the time from the date of randomization to the date response criteria were first met
Time frame: Up to approximately 84 months
TTNT is defined as the time from the date of randomization to the date of next anti-CLL/SLL treatment
Time frame: Up to approximately 25 months
The rate of uMRD4 in peripheral blood based on NGS
Time frame: Baseline and up to approximately 69 months
The EORTC QLQ-30 contains 30 questions that incorporate 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 1 global health status scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The participant answers questions about their health during the past week. There are 28 questions answered on a 4-point scale where 1 =Not at all (best) to 4 =Very Much (worst) and 2 questions answered on a 7-point scale where 1 =Very poor (worst) to 7 =Excellent (best). Higher scores in global health status (GHS) and functional scales indicate better health-related quality of life (HRQoL).
Time frame: Baseline and up to approximately 69 months
The EORTC QLQ-CLL17 is the CLL module of QLQ-C30 consisting of 17 items and comprising 3 scales: symptom burden due to disease and/or treatment (6 items), physical condition/fatigue (4 items), and worries/fears about health and functioning (7 items) Items are rated using a 4-point response scale ("not at all," "a little," "quite a bit," and "very much") and the recall period for all items is the past 7 days. Lower scores indicate better HRQoL.
Time frame: From the first dose of study drug(s) to 30 days after the last dose of sonrotoclax or venetoclax, or 90 days after the last dose of obinutuzumab or rituximab; up to approximately 26 months
Number of participants with TEAEs, including laboratory values, vital signs, and physical examination findings, graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0.
Contact information is provided by the study sponsor or research team.
BeOne Medicines
Industry
A Phase 3 Randomized, Open-Label, Multicenter Study of Sonrotoclax Plus Anti-CD20 Antibody Therapies Versus Venetoclax Plus Rituximab in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
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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