Summary:
A Phase 2, Open-Label, 2-Cohort Study of INCB050465, a PI3Kδ Inhibitor, in Subjects With Relapsed or Refractory Marginal Zone Lymphoma With or Without Prior Exposure to a BTK Inhibitor
Inclusions:
- Men and women, aged 18 or older
- Histologically confirmed MZL, including extranodal, nodal, and splenic subtypes.
- Previously received 1 or more lines of systemic therapy, including at least 1 anti-CD20 antibody (either as monotherapy or in combination as chemoimmunotherapy), with documented progression or documented failure to achieve CR or PR after the most recent systemic treatment regimen.
a. Subjects in Cohort 1 must have received prior ibrutinib.
b. Subjects in Cohort 2 must not have received a prior BTK inhibitor (eg, ibrutinib).
c. Subjects with H. pylori-positive gastric extranodal MZL who received an initial treatment with currently accepted antibiotics may be considered eligible if, after antibiotic regimen, subject has histologically confirmed MZL and was subsequently treated with at least 1 line of systemic therapy
Qualified Participants May Receive:
Eligible particpants will receive treatment and procedures at no cost