Mantle Cell Lymphoma
Conditions
Brief summary
The primary endpoint of the study is the overall response rate (ORR), defined as the proportion of subjects achieving either a partial response (PR) or complete response (CR) according to the Lugano Classification for NHL as assessed by investigators.
Detailed description
Efficacy: • duration of response (DOR) • progression-free survival (PFS) • overall survival (OS) • IRC-assessed ORR, DOR and PFS per Lugano Classification, Safety: • frequency and severity of adverse events • frequency of adverse events requiring discontinuation of study drug or dose reductions • effect of acalabrutinib on peripheral T/B/natural killer (NK) cell counts • effect of acalabrutinib on serum immunoglobulin levels, Pharmacokinetics: • plasma pharmacokinetics of acalabrutinib
Interventions
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 the overall response rate (ORR), defined as the proportion of subjects achieving either a partial response (PR) or complete response (CR) according to the Lugano Classification for NHL as assessed by investigators. | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy: • duration of response (DOR) • progression-free survival (PFS) • overall survival (OS) • IRC-assessed ORR, DOR and PFS per Lugano Classification, Safety: • frequency and severity of adverse events • frequency of adverse events requiring discontinuation of study drug or dose reductions • effect of acalabrutinib on peripheral T/B/natural killer (NK) cell counts • effect of acalabrutinib on serum immunoglobulin levels, Pharmacokinetics: • plasma pharmacokinetics of acalabrutinib | — |
Countries
France, Poland
Outcome results
None listed