Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) / Small Lymphocytic Lymphoma (SLL)
Conditions
Brief summary
CLL PFS per iwCLL 2018 criteria assessed by independent review committee (IRC); SLL PFS per Lugano 2014 criteria assessed by IRC.
Detailed description
OS as key secondary endpoint, time to next treatment (TTNT), event-free survival (EFS) assessed by investigators (INV)., Overall response rate (ORR), duration of response (DOR) assessed by IRC and INV., CLL PFS per iwCLL 2018 criteria assessed by INV; SLL PFS per Lugano 2014 criteria assessed by INV., Concordance between IRC-assessed PFS and INV-assessed PFS., Including, but not limited to, serious adverse events (SAEs), adverse events (AEs), deaths and clinical laboratory abnormalities per National Cancer Institute Common Terminology Criteria in Adverse Events v5.0 (NCI CTCAE v5.0)., Plasma concentrations of rocbrutinib at scheduled sparse PK timepoints and population PK parameters and derived individual exposure estimates.
Interventions
Sponsors
Newave Pharmaceutical Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CLL PFS per iwCLL 2018 criteria assessed by independent review committee (IRC); SLL PFS per Lugano 2014 criteria assessed by IRC. | — |
Secondary
| Measure | Time frame |
|---|---|
| OS as key secondary endpoint, time to next treatment (TTNT), event-free survival (EFS) assessed by investigators (INV)., Overall response rate (ORR), duration of response (DOR) assessed by IRC and INV., CLL PFS per iwCLL 2018 criteria assessed by INV; SLL PFS per Lugano 2014 criteria assessed by INV., Concordance between IRC-assessed PFS and INV-assessed PFS., Including, but not limited to, serious adverse events (SAEs), adverse events (AEs), deaths and clinical laboratory abnormalities per National Cancer Institute Common Terminology Criteria in Adverse Events v5.0 (NCI CTCAE v5.0)., Plasma concentrations of rocbrutinib at scheduled sparse PK timepoints and population PK parameters and derived individual exposure estimates. | — |
Outcome results
None listed