Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Conditions
Brief summary
PFS, defined as the time from the date of randomization until date of objective progressive disease per iwCLL 2018 criteria as assessed by the investigator or death from any cause in the absence of progression
Detailed description
Rate of peripheral blood uMRD, Overall survival, Event-free survival, Overall response rate, CR rate after completion of 12 cycles of venetoclax, Change from baseline in EORTC QLQ-C30, EORTC QLQ-CLL17 scales, Proportion of participants experiencing bruising, Proportion of participants reporting each response option of the PGI-BR
Interventions
DRUGVenclyxto 10 mg film-coated tablets
DRUGVenclyxto 100 mg film-coated tablets
DRUGGazyvaro 1
DRUG000 mg concentrate for solution for infusion.
DRUGVenclyxto 50 mg film-coated tablets
Sponsors
Astrazeneca AB
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS, defined as the time from the date of randomization until date of objective progressive disease per iwCLL 2018 criteria as assessed by the investigator or death from any cause in the absence of progression | — |
Secondary
| Measure | Time frame |
|---|---|
| Rate of peripheral blood uMRD, Overall survival, Event-free survival, Overall response rate, CR rate after completion of 12 cycles of venetoclax, Change from baseline in EORTC QLQ-C30, EORTC QLQ-CLL17 scales, Proportion of participants experiencing bruising, Proportion of participants reporting each response option of the PGI-BR | — |
Countries
Czechia, France, Hungary, Poland, Spain
Outcome results
None listed