Chronic lymphocytic leukemia/Small lymphocytic lymphoma; Richters transformation; Mantle cell lymphoma, Marginal zone lymphoma; Follicular lymphoma; Waldenström’s macroglobulinemia
Conditions
Brief summary
Part 1: Number of participants experiencing dose-limiting toxicities (DLTs), Part 1: Number of participants experiencing adverse events (AEs), Part 1: Number of participants discontinuing study treatment due to AEs, Part 2: Objective Response Rate (ORR) per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria 2018 as assessed by independent central review (ICR), Part 2: ORR per Lugano criteria 2014 as assessed by ICR, Part 2: ORR per International Workshop on Waldenström’s Macroglobulinemia (IWWM) criteria 2014 as assessed by ICR
Detailed description
Part 1: Area Under the Curve (AUC) of nemtabrutinib, Part 1: Minimum Concentration (Cmin) of nemtabrutinib, Part 1: Maximum Concentration (Cmax) of nemtabrutinib, Part 1: ORR per iwCLL criteria 2018 as assessed by ICR, Part 1: Duration of Response (DOR) per iwCLL criteria 2018 as assessed by ICR, Part 2: Number of participants experiencing AEs, Part 2: Number of participants discontinuing study treatment due to AEs, Part 2: AUC of nemtabrutinib, Part 2: Cmin of nemtabrutinib, Part 2: Cmax of nemtabrutinib, Part 2: DOR per iwCLL criteria 2018 as assessed by ICR, Part 2: DOR per Lugano criteria 2014 as assessed by ICR, Part 2: DOR per IWWM criteria 2014 as assessed by ICR
Interventions
DRUGNemtabrutinib
Sponsors
Merck Sharp & Dohme LLC
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part 1: Number of participants experiencing dose-limiting toxicities (DLTs), Part 1: Number of participants experiencing adverse events (AEs), Part 1: Number of participants discontinuing study treatment due to AEs, Part 2: Objective Response Rate (ORR) per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria 2018 as assessed by independent central review (ICR), Part 2: ORR per Lugano criteria 2014 as assessed by ICR, Part 2: ORR per International Workshop on Waldenström’s Macroglobulinemia (IWWM) criteria 2014 as assessed by ICR | — |
Secondary
| Measure | Time frame |
|---|---|
| Part 1: Area Under the Curve (AUC) of nemtabrutinib, Part 1: Minimum Concentration (Cmin) of nemtabrutinib, Part 1: Maximum Concentration (Cmax) of nemtabrutinib, Part 1: ORR per iwCLL criteria 2018 as assessed by ICR, Part 1: Duration of Response (DOR) per iwCLL criteria 2018 as assessed by ICR, Part 2: Number of participants experiencing AEs, Part 2: Number of participants discontinuing study treatment due to AEs, Part 2: AUC of nemtabrutinib, Part 2: Cmin of nemtabrutinib, Part 2: Cmax of nemtabrutinib, Part 2: DOR per iwCLL criteria 2018 as assessed by ICR, Part 2: DOR per Lugano criteria 2014 as assessed by ICR, Part 2: DOR per IWWM criteria 2014 as assessed by ICR | — |
Countries
Czechia, Denmark, France, Germany, Hungary, Ireland, Italy, Poland, Romania, Spain
Outcome results
None listed