DUO: a phase 3 trial of the PL3K-delta,gamma inhibitor IPI-145 versus ofatumumab in patients with relapsed or refractory chronic lymphocytic leukemia or small lymphorytic lymphoma

TPS7122 Background: Phosphoinositide 3-kinase (PI3K)-δ,γ isoforms are preferentially expressed in leukocytes and are central to the growth and survival of certain B and T cell malignancies. Inhibition of these isoforms by IPI-145, an oral PI3K-δ,γ inhibitor, has unique therapeutic potential in hematologic malignancies. IPI-145 has shown clinical activity and a favorable safety profile in a broad range of hematologic malignancies in an ongoing phase 1 trial (IPI-145-02). Based on these data, the DUO phase 3 trial (IPI-145-07; ClinicalTrials.gov number: NCT02004522) has been initiated to evaluate the efficacy and safety of IPI-145 compared to ofatumumab in patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Methods: This open-label, two-arm trial includes adult patients with active CLL/SLL who meet at least one of the International Workshop on CLL (IWCLL) 2008 treatment criteria; have disease progression during or after previous CLL therapy; are not a...