Waldenström Macroglobulinemia
Conditions
Brief summary
ORR, defined as a subject achieving a MR or better according to the response assessment criteria for WM as assessed by the investigator, ORR, defined as a subject achieving a MR or better according to the response assessment criteria defined by modified 3rd IWWM workshop criteria as assessed by the investigator
Detailed description
Efficacy: •DOR assessed by the investigator using response assessment criteria for WM and modified 3rd IWWM workshop criteria • PFS assessed by the investigator using response assessment criteria for WM and Modified 3rd IWWM workshop criteria • Overall survival (OS) •Effect of acalabrutinib on peripheral T/B/NK cell counts •Effect of acalabrutinib on serum immunoglobulin levels, Safety: •Frequency, severity, and relatedness of AEs •Frequency of AEs requiring discontinuation of study drug or dose reductions, Pharmacokinetics: •Plasma pharmacokinetics of acalabrutinib, Patient Reported Outcomes (PRO): •Health-related quality of life
Interventions
Sponsors
Acerta Pharma B.V.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Efficacy: •DOR assessed by the investigator using response assessment criteria for WM and modified 3rd IWWM workshop criteria • PFS assessed by the investigator using response assessment criteria for WM and Modified 3rd IWWM workshop criteria • Overall survival (OS) •Effect of acalabrutinib on peripheral T/B/NK cell counts •Effect of acalabrutinib on serum immunoglobulin levels, Safety: •Frequency, severity, and relatedness of AEs •Frequency of AEs requiring discontinuation of study drug or dose reductions, Pharmacokinetics: •Plasma pharmacokinetics of acalabrutinib, Patient Reported Outcomes (PRO): •Health-related quality of life | — |
Primary
| Measure | Time frame |
|---|---|
| ORR, defined as a subject achieving a MR or better according to the response assessment criteria for WM as assessed by the investigator, ORR, defined as a subject achieving a MR or better according to the response assessment criteria defined by modified 3rd IWWM workshop criteria as assessed by the investigator | — |
Countries
France, Greece, Italy
Outcome results
None listed