Previously Untreated Chronic Lymphocytic Leukemia
Conditions
Brief summary
Cohort 1: PFS, defined as time from the date of enrollment to the date of first confirmed disease progression or death due to any cause, whichever occurs first, as determined by IRC., Intermediate (Cohort 1): Undetectable minimal residual disease at < 10^-4 sensitivity (uMRD4) rate at the first Post-treatment Follow-up (PTFU1) Visit based on next-generation sequencing (NGS [clonoSEQ]).
Detailed description
Cohort 1: Overall complete response rate (CRR) defined as the proportion of patients that achieved best response of CR/CRi, determined by IRC., Cohort 1: OS, defined as time from the date of enrollment to the date of death because of any cause
Interventions
DRUGBGB-11417
DRUGZanubrutinib
DRUGGazyvaro 1
DRUG000 mg concentrate for solution for infusion.
DRUGVenclyxto 100 mg film-coated tablets
Sponsors
BeOne Medicines AG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cohort 1: PFS, defined as time from the date of enrollment to the date of first confirmed disease progression or death due to any cause, whichever occurs first, as determined by IRC., Intermediate (Cohort 1): Undetectable minimal residual disease at < 10^-4 sensitivity (uMRD4) rate at the first Post-treatment Follow-up (PTFU1) Visit based on next-generation sequencing (NGS [clonoSEQ]). | — |
Secondary
| Measure | Time frame |
|---|---|
| Cohort 1: Overall complete response rate (CRR) defined as the proportion of patients that achieved best response of CR/CRi, determined by IRC., Cohort 1: OS, defined as time from the date of enrollment to the date of death because of any cause | — |
Countries
Austria, Czechia, France, Germany, Italy, Netherlands, Poland, Spain, Sweden
Outcome results
None listed