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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
630
Administered orally
Administered intravenously
Administered intravenously
Administered Orally
Uci Health Laguna Hills
Laguna Hills, California, United States
RECRUITINGChao Family Comprehensive Cancer Center
Orange, California, United States
RECRUITINGStanford Cancer Institute
Palo Alto, California, United States
RECRUITINGScripps Prebys Cancer Center
San Diego, California, United States
Progression-Free Survival (PFS) as assessed by Blinded Independent Review Committee (BIRC) for Arm A versus Arm D
PFS is defined as the time from randomization to the date of progression or death, whichever occurs first.
Time frame: Up to approximately 51 months
Progression-Free Survival (PFS) as assessed by BIRC for Arm B versus Arm D
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
Rate of uMRD4 for Arm A versus Arm D
The rate of undetectable minimal residual disease (uMRD4) in peripheral blood based on next-generation sequencing (NGS)
Time frame: Up to approximately 12 months
Complete Response Rate as assessed by BIRC for Arm A versus Arm D
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 25 months
Overall Survival for Arm A versus Arm D
Overall survival (OS) is defined as the time from the date of randomization to the date of death
Time frame: Up to approximately 84 months
PFS per Investigator Assessment (INV) for Arm B versus Arm D
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
CRR per BIRC and by INV for Arm B versus Arm D
CRR is defined as the percentage of participants that achieve a best response of CR or CRi
Time frame: Up to approximately 25 months
OS for Arm B versus Arm D
OS is defined as the time from the date of randomization to the date of death
Time frame: Up to approximately 84 months
Rate of uMRD4 for Arm B versus Arm D
The rate of uMRD4 in peripheral blood based on NGS
Time frame: Up to approximately 25 months
PFS per BIRC and by INV for Arm A versus Arm B
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
CRR per BIRC and by INV for Arm A versus Arm B
CRR is defined as the percentage of participants that achieve a best response of CR or CRi
Time frame: Up to approximately 25 months
OS for Arm A versus Arm B
OS is defined as the time from the date of randomization to the date of death
Time frame: Up to approximately 84 months
Rate of uMRD4 for Arm A versus Arm B
The rate of uMRD4 in peripheral blood based on NGS
Time frame: Up to approximately 25 months
Rate of uMRD4 for Arm A versus Arm D
The rate of uMRD4 in peripheral blood based on NGS
Time frame: Up to approximately 25 months
CRR per INV for Arm A versus Arm D
CRR is defined as the percentage of participants that achieve a best response of CR or CRi
Time frame: Up to approximately 25 months
PFS per INV for Arm A versus Arm D
PFS is defined as the time from randomization to the date of progression or death, whichever occurs first.
Time frame: Up to approximately 51 months
PFS per INV for Arm C versus Arm D
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
CRR per INV for Arm C versus Arm D
CRR is defined as the percentage of participants that achieve a best response of CR or CRi
Time frame: Up to approximately 25 months
OS for Arm C versus Arm D
OS is defined as the time from the date of randomization to the date of death
Time frame: Up to approximately 84 months
Rate of uMRD4 for Arm C versus Arm D
The rate of uMRD4 in peripheral blood based on NGS
Time frame: Up to approximately 25 months
Overall Response Rate (ORR) per BIRC and by INV
ORR is defined as the percentage of participants that achieve a best response of partial response (PR) or better
Time frame: Up to approximately 25 months
Duration of Response (DOR) per BIRC and by INV
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 69 months
Time to Response (TTR) per BIRC and by INV
TTR is defined as the time from the date of randomization to the date response criteria were first met
Time frame: Up to approximately 25 months
Time to Next Anti-CLL/SLL Treatment (TTNT)
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 84 months
Rate of uMRD4
The rate of uMRD4 in peripheral blood based on NGS
Time frame: Up to approximately 25 months
Change from Baseline in the European Organisation of Research and Treatment of Cancer-Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30) Global Health Status/Quality of Life and Physical Functioning Scales
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
Change from Baseline in EORTC QLQ for Chronic Lymphocytic Leukemia (EORTC QLQ-CLL17) Symptom Burden and Fatigue Scales
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: Baseline and up to approximately 69 months
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
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.
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Rocky Mountain Cancer Centers (Williams) Usor
Aurora, Colorado, United States
RECRUITINGYale University Yale Cancer Center
New Haven, Connecticut, United States
RECRUITINGEastern Connecticut Hematology and Oncology
Norwich, Connecticut, United States
RECRUITINGCleveland Clinic Florida
Weston, Florida, United States
RECRUITINGNorthwestern University
Chicago, Illinois, United States
RECRUITINGIllinois Cancer Specialists (Niles) Usor
Niles, Illinois, United States
RECRUITING...and 185 more locations