Chronic Lymphocytic Leukemia
Conditions
Brief summary
The primary endpoint of the study is PFS as assessed by IRC review per IWCLL 2008 criteria. The primary analysis is a comparison of PFS between Arm A and Arm B.
Detailed description
"Efficacy: The first secondary endpoint is a comparison of IRC-assessed PFS between Arm A and Arm C. Other secondary endpoints are as follows and compare Arm A versus Arm B and Arm A versus Arm C • OS. Safety: • Frequency, severity, and relatedness of adverse events. • Frequency of adverse events requiring discontinuation of study drug or dose reductions. • Change in laboratory assessments. ", Efficacy: The first secondary endpoint is a comparison of IRC-assessed PFS between Arm A and Arm C. Other secondary endpoints are as follows and compare Arm A versus Arm B and Arm A versus Arm C • OS. Safety: • Frequency, severity, and relatedness of adverse events. • Frequency of adverse events requiring discontinuation of study drug or dose reductions. • Change in laboratory assessments.
Interventions
DRUGGazyvaro 1
DRUG000 mg concentrate for solution for infusion.
Sponsors
Acerta Pharma B.V.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of the study is PFS as assessed by IRC review per IWCLL 2008 criteria. The primary analysis is a comparison of PFS between Arm A and Arm B. | — |
Secondary
| Measure | Time frame |
|---|---|
| "Efficacy: The first secondary endpoint is a comparison of IRC-assessed PFS between Arm A and Arm C. Other secondary endpoints are as follows and compare Arm A versus Arm B and Arm A versus Arm C • OS. Safety: • Frequency, severity, and relatedness of adverse events. • Frequency of adverse events requiring discontinuation of study drug or dose reductions. • Change in laboratory assessments. ", Efficacy: The first secondary endpoint is a comparison of IRC-assessed PFS between Arm A and Arm C. Other secondary endpoints are as follows and compare Arm A versus Arm B and Arm A versus Arm C • OS. Safety: • Frequency, severity, and relatedness of adverse events. • Frequency of adverse events requiring discontinuation of study drug or dose reductions. • Change in laboratory assessments. | — |
Countries
Belgium, France, Germany, Hungary, Italy, Lithuania, Poland, Spain, Sweden
Outcome results
None listed