A Phase 2 Safety and Efficacy Study of Parsaclisib in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (CITADEL-202)

Inclusion Criteria:

- Eligible 19 years and older in South Korea

- Relapsed or refractory DLBCL, which has been histologically documented, defined as
having received at least 2 but no more than 5 prior treatment regimens and ineligible
for high-dose chemotherapy supported by autologous stem cell transplant.

- Must have ≥ 1 measurable lesion (≥2 cm in longest dimension) or ≥ 1 measurable
extranodal lesion (≥1 cm in longest dimension) on computed tomography (CT) scan or
magnetic resonance imaging (MRI).

- Subjects must be willing to undergo an incisional or excisional lymph node biopsy of
accessible adenopathy or provide the most recent, available archived tumor biopsy.

- Eastern Cooperative Oncology Group performance status 0 to 2.

Exclusion Criteria:

- Primary mediastinal (thymic) large B-cell lymphoma.

- Known brain or central nervous system metastases or history of uncontrolled seizures.

- Allogeneic stem cell transplant within the last 6 months, or active graft versus host
disease following allogeneic transplant, or autologous stem cell transplant within the
last 3 months.

- Use or expected use during the study of any prohibited medications, including potent
cytochrome P450 3A4 inhibitors or inducers within 14 days or 5 half lives (whichever
is longer) before the first dose of study drug.

- Prior treatment with the following:

- Group A: Prior treatment with a selective phosphatidylinositol 3-kinase (PI3K) δ
inhibitor (eg, idelalisib), a pan-PI3K inhibitor, or a BTK inhibitor (eg,
ibrutinib).

- Group B: Prior treatment with a selective PI3Kδ inhibitor (eg, idelalisib) or a
pan PI3K inhibitor.