Chronic Lymphocytic Leukemia, Prolymphocytic Leukemia, Richter's Syndrome
Conditions
Brief summary
Efficacy Parameters • Overall response rate • Duration of response • Progression-free survival (with a subgroup analysis by sex, male vs female for overall response rate, duration of response), Safety Parameters • DLTs and MTD • Frequency, severity, and attribution of adverse events (AEs), Pharmacokinetic and Pharmacodynamic Parameters The occupancy of BTK by acalabrutinib will be measured in peripheral blood mononuclear cells (PBMCs) with the aid of a biotin-tagged acalabrutinib analogue probe. The effect of acalabrutinib on biologic markers of B-cell function will also be evaluated
Interventions
Sponsors
Acerta Pharma B.V.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy Parameters • Overall response rate • Duration of response • Progression-free survival (with a subgroup analysis by sex, male vs female for overall response rate, duration of response), Safety Parameters • DLTs and MTD • Frequency, severity, and attribution of adverse events (AEs), Pharmacokinetic and Pharmacodynamic Parameters The occupancy of BTK by acalabrutinib will be measured in peripheral blood mononuclear cells (PBMCs) with the aid of a biotin-tagged acalabrutinib analogue probe. The effect of acalabrutinib on biologic markers of B-cell function will also be evaluated | — |
Countries
Italy
Outcome results
None listed