Chronic lymphocytic leukemia/small lymphocytic lymphoma
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - Diagnosis of active CLL or SLL - Disease that has progressed during or relapsed after at least one previous CLL/SLL therapy - Measurable disease > 1.5 cm - ECOG PS of 0 or 1 - Presence of adequate organ and bone-marrow functions
Exclusion criteria
Exclusion criteria: - History of Richter's transformation or prolymphocytic leukemia - Known central nervous system lymphoma or leukemia - Prior exposure to a PI3K inhibitor - Unstable or severe uncontrolled medical condition - Pregnant or lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy ORR | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy PFS OS | — |
Countries
Japan